A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

Dry Eye Syndromes Clinical Trial

Official title:

A Phase II, Prospective, Randomized, Double Masked/Investigator Masked, Vehicle And Comparator (Sodium Hyaluronate Eye Drops) Controlled, Dose Ranging Study Of CP-690,550 Eye Drops In Subjects With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135511
• Other study ID #: A3921072
• Status: Completed
• Phase: Phase 2
• First received: June 1, 2010
• Last updated: March 27, 2013
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: March 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Subjective symptoms of dry eye for at least 6 months

• Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)

Exclusion Criteria:

• Women who are nursing, pregnant or planning pregnancy during the study

• Participation in other studies within 30 days of screening visit

• Ocular disorders that may confound interpretation of study results

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• CP-690,550 Eye drops
Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
• CP-690,550 Eye drops
Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
• CP-690,550 Eye drops
Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
• CP-690,550 Eye drops-vehicle
Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
• Sodium Hyaluronate
Ophthalmic topical solution, dosed 6 times/day, 8 weeks

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Chiba
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Fuji	Shizuoka
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Hamura	Tokyo
Japan	Pfizer Investigational Site	Ichinomiya	Aichi
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Minato-ku	Tokyo
Japan	Pfizer Investigational Site	Narashino	Chiba
Japan	Pfizer Investigational Site	Numazu	Shizuoka
Japan	Pfizer Investigational Site	Ohta-ku	Tokyo
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Shizuoka
Japan	Pfizer Investigational Site	Sumida-ku	Tokyo
Japan	Pfizer Investigational Site	Susono	Shizuoka
Japan	Pfizer Investigational Site	Tachikawa	Tokyo
Japan	Pfizer Investigational Site	Taito-ku	Tokyo
Japan	Pfizer Investigational Site	Tokyo
Japan	Pfizer Investigational Site	Urayasu	Chiba
Japan	Pfizer Investigational Site	Yokohama	Kanagawa
Japan	Pfizer Investigational Site	Yokohama	Kangawa
Korea, Republic of	Pfizer Investigational Site	Gwangju
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Human Leukocyte Antigen-DR Antibody Bound Per Cell for Study Eye	The average level of HLA-DR expression per cell was reported as HLA-DR antibody bound per cell (ABC).; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change = value at observation minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in Expression of Inflammatory Markers on Conjunctival Cells From Baseline: Percentage of Human Leukocyte Antigen (HLA)-DR Positive for Study Eye	Percentage of conjunctival epithelial cells that were positive with HLA-DR expression was calculated as HLA-DR Positive.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Apolipoprotein C-3	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-18	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-6	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-7	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-8	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Monocyte Chemotactic Protein 1	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-12 P40/P35 Heterodimer (IL-12P70)	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Beta	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-1 Receptor Antagonist	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-23	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-3	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Matrix Metalloproteinase-9	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Vascular Endothelial Growth Factor	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Alpha-1 Antitrypsin	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Interleukin-17A	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 10 (CXCL10) (Alias Gamma-Interferon Inducible Protein 10: IP10)	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-X-C Motif) Ligand 9 (CXCL9) (Alias Monokine Induced by Gamma Interferon: MIG)	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine ( C-C Motif) Ligand 20 (CCL20) (Alias Macrophage Inflammatory Protein 3 Alpha: MIP3A)	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Chemokine (C-C Motif) Ligand 5 (CCL5) (Alias Regulated on Activation, Normal T Cell Expressed, and Secreted: RANTES)	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Tissue Inhibitor of Metalloproteinase 1 (TIMP-1)	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Epidermal Growth Factor	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Albumin	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 5AC	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Number of Participants Evaluated for Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 4	Number of analyzed with sufficient quantity for analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline - Mucin 16 Carbohydrate Antigen 125	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Mucin 1	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Lipocalin 1	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Other	Change in the Biomarker in Tear Fluid for Study Eye From Baseline -Total Protein	Analysis of biomarkers which were immune and inflammatory mediators such as cytokines, chemokines and matrix metalloproteinases.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change= value at visit minus value at baseline.	Baseline, Week 4 and 8	No
Primary	Changes in Corneal Staining Scores for Study Eye From Baseline at Week 8	Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 8	No
Secondary	Changes in Corneal Staining Scores for Study Eye From Baseline	Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale:0=none, 1=slight, 2=moderate, 3=severe. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 1, 2 and 4	No
Secondary	Percentage of Participants Demonstrating 100 Percent Clearing of Corneal Staining for Study Eye	Percentage of participants demonstrating corneal staining score = 0 which indicates no damage in corneal surface.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 1, 2, 4 and 8	No
Secondary	Changes in Conjunctival Staining Scores (Interpalpebral) for Study Eye From Baseline	Based on the Oxford grading system, the bulbar conjunctiva of each eye was divided into 2 different zones (nasal and temporal). The nasal and temporal bulbar conjunctival zones were each graded independently using a 6-point scale (0 [Absent] to 5 [Severe]). Total score ranged from 0 (Absent) to 10 (severe), higher score=higher damage to eyes due to dryness. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Changes in Tear Break Up Time (TBUT) for Study Eye From Baseline	TBUT is the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Using a stopwatch, the time between last complete blink and first appearance of dry spot was recorded.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Changes in Schirmer Test Values Without Anesthesia for Study Eye From Baseline	The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: value at observation minus value at baseline. Positive change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Percentage of Participants Who Achieve =10 mm Schirmer Test Value Without Anesthesia for Study Eye	The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 1, 2, 4 and 8	No
Secondary	Number of Participants Who Increase of =10 mm From Baseline in Schirmer Test Value Without Anesthesia for Study Eye	The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac. The length of wetting (distance from the notch) was recorded in millimeters (to the nearest 0.5 mm). If the wetting line was oblique, the halfway point was used.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 1, 2, 4 and 8	No
Secondary	Changes in the Ocular Comfort Index (OCI) Total Score From Baseline	The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Number of Participants Demonstrating at Least =3 Unit Decrease in Ocular Comfort Index (OCI) Total Score From Baseline	The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Total score ranged from 0 (none) to 72 (severe symptoms). A higher score indicates more severe dry eye symptoms.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change = scores at observation minus score at baseline. Negative change from baseline indicated improvement.	Week 1, 2, 4 and 8	No
Secondary	Changes in the Ocular Surface Disease Index (OSDI) Total Score From Baseline	The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.; The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].; The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Ocular Symptoms	The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.; The 12 items of the OSDI questionnaire were graded on a scale of 0 [the none of time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 1 to 3 answered) × 100]/[(total number of questions 1 to 3 answered) × 4].; The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Vision-Related Function	The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.; The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 4 to 9 answered) × 100]/[(total number of questions 4 to 9 answered) × 4].; Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Changes in the Ocular Surface Disease Index (OSDI) Subscale Score From Baseline: Environmental Triggers	The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.; The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The subscale OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for questions 10 to 12 answered) × 100]/[(total number of questions 10 to 12 answered) × 4].; The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.; Change: score at observation minus score at baseline. Negative change from baseline indicated improvement.	Baseline, Week 1, 2, 4 and 8	No
Secondary	Percentage of Participants Demonstrating =10 Unit Decrease in Ocular Surface Disease Index (OSDI) Total Score From Baseline	The OSDI is a validated instrument for ocular surface diseases, measuring the ocular symptoms, vision-related function, and environmental triggers.; The 12 items of the OSDI questionnaire were graded on a scale of 0 [none of the time] to 4 [all of the time]. The total OSDI score was then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) × 100]/[(total number of questions answered) × 4].; The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 1, 2, 4 and 8	No
Secondary	Number of Participants Evaluable for Time to Achievement of 100% Clearing of Corneal Staining for Study Eye	Based on the National Eye Institute (NEI) dry eye clinical trials workshop, the cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale. The maximum possible staining score is 15, higher score indicated greater staining.; 100% Clearing of Corneal Staining means corneal staining score = 0. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 8	No
Secondary	Number of Participants Evaluable for Time to Achievement of =10 mm Schirmer Wetting Score Without Anesthesia for Study Eye	The Schirmer test without anesthesia was used to estimate tear flow stimulated reflexly by insertion of a filter paper strip into the conjunctival sac.; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 8	No
Secondary	Number of Participants Evaluable for Time to Achievement of =3 Unit Decrease in OCI Scores	The OCI is a validated instrument developed to measure the frequency and intensity of 6 common dry eye symptoms: dryness, grittiness, stinging, eye tiredness, pain, and itching. It contains 12 questions, each measured on a 7-point rating scale (0 [Never] to 6 [Always], or 0 [Never had it] to 6 [Severe]). Negative change from baseline indicated improvement. Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	Week 8	No
Secondary	Number of Participants With Ocular Adverse Events (AEs)by Severity	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Ocular AEs are the events which are localized in the ocular region. Participants with multiple occurrences of an AE within a category were counted once within the category.	8 weeks	Yes
Secondary	Number of Participants With Nonocular Adverse Events (AEs) by Severity	Counts of participants who had treatment-emergent nonocular AEs, defined as newly occurring or worsening after first dose. Participants with multiple occurrences of an AE within a category were counted once within the category.	8 weeks	Yes
Secondary	Summary of Maximum Severity of Ocular Tolerability Assessments Post Baseline for Study Eye: Number of Participants in Each Severity Scale	Ocular tolerability was assessed for the 5 symptoms (burning sensation, blurred vision, ocular discomfort, pain, tearing), based on a 4-point severity scale (none, minor, moderate, and severe).; Results from study eye are reported. The study eye was defined as the eye with the worse (higher) corneal staining score at baseline.	8 weeks	Yes

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