Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02254265
Other study ID # OTX-101-2014-001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 2014
Est. completion date May 2015

Study information

Verified date November 2021
Source Sun Pharmaceutical Industries Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).


Description:

Keratoconjunctivitis sicca (KCS) is a common multifactorial ophthalmologic disorder of the tears and ocular surface characterized by symptoms of burning, stinging, itching, grittiness, scratchiness, foreign body sensation, dryness, stickiness and tired eye sensation. This study is the first clinical safety and efficacy study with OTX-101 and is designed to compare two dose concentrations of OTX-101 against vehicle (placebo) in reducing the signs and symptoms of KCS and evaluate safety when dosed twice a day in both eyes over an 84 day period.


Recruitment information / eligibility

Status Completed
Enrollment 455
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects age 18 years or older on the date of informed consent. 2. All subjects must provide signed written consent prior to participation in any study-related procedures. 3. Patient-reported history of KCS for a period of at least 6 months. 4. Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments. 5. Lissamine green conjunctival staining sum score of = 3 to = 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at Screening and Baseline. 6. Global symptom score = 40 at both Screening and Baseline. 7. Corrected Snellen VA of better than 20/200 in each eye. 8. Willing to discontinue use of current dry eye therapy (including artificial tears or ocular lubricants) during the study as of the run-in period. 9. Female subjects of childbearing potential must have a negative urine pregnancy test at Screening. Women of childbearing potential (ie, women who are not either postmenopausal for one year or surgically sterile) must use an acceptable form of contraception throughout the study. Exclusion Criteria: 1. Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to Screening. 2. Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion 0.05% (Restasis). 3. Diagnosed with Sjögren's disease ?5 years prior to Screening. 4. Clinical diagnosis of seasonal and perennial allergic conjunctivitis. 5. Use of systemic and topical medications that are known to cause dry eye within 7 days prior to Screening and throughout the study period. These include the following medications: - Immunomodulators (permitted if dose is stable for 3 months prior to screening and does not change during the study period) - Antihistamines (including over-the counter (OTC)) - Cholinergics - Antimuscarinics - Tricyclic antidepressants - Phenothiazines - Retinoids 6. Oral omega-3 fatty acids (permitted if dose is stable for 3 months prior to Screening and does not change during the study period) 7. Use of any topical ophthalmic medications, prescription (including antiglaucoma medications) or OTC (including artificial tears), other than the assigned study medication during the study period. 8. Current active eye disease other than KCS (i.e., any disease for which topical or systemic ophthalmic medication is necessary). 9. History of herpes keratitis. 10. Unstable macular disease (e.g., age-related macular degeneration, diabetic maculopathy). Stable macular disease is defined as no reduction in central VA within 6 months prior to Screening. 11. Diagnosis of chronic uveitis. 12. Corneal transplant (e.g., penetrating keratoplasty, lamellar keratoplasty, Descemet's stripping endothelial keratoplasty (DSEK) ). 13. Corneal refractive surgery (e.g., laser-assisted in situ keratomileusis (LASIK]) photo refractive keratectomy (PRK), limbal relaxing incision (LRI) ) within 6 months prior to screening or postoperative refractive surgery symptoms of dryness that have not resolved. 14. Cataract surgery within 3 months prior to Screening. 15. Non-laser glaucoma surgery at any time; glaucoma laser procedures within 3 months prior to Screening. 16. Presence of punctal plugs or past history of permanent punctal occlusion (e.g., cautery). 17. Lagophthalmos or clinically significant eyelid margin irregularity of the study eye whether congenital or acquired. 18. Presence of conjunctivochalasis (i.e., mechanical blockage of the lower lid punctum by redundant conjunctiva). 19. Presence of pterygium in the study eye. 20. Unwilling to discontinue use of contact lenses during the duration of the study. 21. Preplanned elective surgery or hospitalization during the study period. 22. HIV-positive. 23. Unable to reliably report symptoms and history. 24. Has known hypersensitivity or contraindication to the study medication(s) or their components. 25. Has a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study. 26. Has a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up. 27. Women who are pregnant or breastfeeding. 28. Participation in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation. 29. Previous randomization into this study.

Study Design


Intervention

Drug:
OTX-101 0.05%
OTX-101 0.05% Ophthalmic Solution
OTX-101 0.09%
OTX-101 0.09% Ophthalmic Solution
Vehicle
Vehicle of OTX-101 Ophthalmic Solution

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Conjunctival Staining Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye.
The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale
Baseline to 84 days
Primary Global Symptom Score Mean change from baseline at day 84 for the global symptom score.
The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows:
Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe).
The global symptom score was calculated as the square root of the frequency score times the severity score
Baseline to 84 days
Secondary Tear Film Break up Time (TBUT) Mean change from baseline in TBUT in the study eye from baseline at Day 84 Baseline to 84 days
Secondary Corneal Staining Score Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale Baseline to 84 days
Secondary Schirmer's Test Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.
1: < 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: > 14 mm
Baseline to 84 days
Secondary Patient Satisfaction Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied) Baseline to 84 days
See also
  Status Clinical Trial Phase
Completed NCT03216096 - Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease Phase 1
Completed NCT05825599 - PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms N/A
Completed NCT04656197 - The Ocular Microbiome in Patients With Dry Eye Disease
Completed NCT05031806 - Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease Phase 1
Completed NCT03688802 - Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation Phase 2
Completed NCT05213156 - Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease Phase 4
Completed NCT04548427 - Study to Evaluate the Efficacy and Safety of CKD-352 Phase 3
Completed NCT06176651 - Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers Phase 4
Completed NCT00395759 - The Visual Effect of an Investigational Artificial Tear in the Tear Layer. N/A
Completed NCT00680108 - A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution Phase 2
Recruiting NCT06064071 - Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD N/A
Completed NCT04139122 - Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease Phase 1/Phase 2
Not yet recruiting NCT06375343 - Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® Phase 1
Completed NCT01468168 - A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients Phase 2
Completed NCT01014078 - A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease Phase 4
Completed NCT00799682 - Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z® Phase 4
Completed NCT05082974 - Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK) Phase 3
Recruiting NCT06146881 - Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia Phase 2
Completed NCT03292809 - CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) Phase 2/Phase 3
Completed NCT01636206 - Safety Study of Lifitegrast to Treat Dry Eye Phase 3