Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Controlled, Double-Masked Study of Safety and Efficacy of Sodium Hyaluronate Ophthalmic Solution, 0.18% in Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382225
• Other study ID #: C-09-045
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2011
• Last updated: May 20, 2013
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to determine if Sodium Hyaluronate, 0.18% is effective in treating the signs and symptoms of dry eye disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1936
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Documented history of dry eyes for at least 3 months.

• Ocular discomfort due to dry eyes.

• Presence of corneal and conjunctival staining.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Women who are pregnant or lactating.

• Contact lens wear within 1 week before Screening and during the study.

• Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.

• Punctal plugs or punctal occlusion initiated within 3 months of screening

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Sodium Hyaluronate Ophthalmic Solution, 0.18%

Other:
• Vehicle
Inactive ingredients used as run-in and placebo comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7	The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.	Baseline, Day 7	No
Primary	Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7	The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.	Baseline, Day 7	No
Secondary	Change From Baseline in LGS Total Score at Day 14	The investigator instilled an ophthalmic dye on the eye and rated staining in three areas (cornea, nasal, and temporal conjunctiva). Staining was rated on a 5-point scale from 0 to 4 (0=0% to 4=>45%). The LGS Total Score (0-12) is the sum of the three individual ratings. A more negative change indicates a greater amount of improvement.	Baseline, Day 14	No
Secondary	Change From Baseline in GSF Total Score at Day 14	The subject completed a questionnaire and rated the frequency of five common dry eye symptoms. Frequency was rated on a 4-point scale from 0 to 3 (0=never to 3=constantly). The GSF Total Score (0-15) is the sum of the five individual ratings. A more negative change indicates a greater amount of improvement.	Baseline, Day 14	No
Secondary	Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score	The investigator instilled an ophthalmic dye on the eye and rated corneal staining by type, extent/surface area, and depth. Each staining was rated on a 5-point scale from 0 to 4 (0=no staining/0% to 4=patch/>45%/immediate diffuse stromal glow). The CFS Total Score (0-12) is the sum of the three individual ratings. A more negative percentage change indicates a greater amount of improvement.	Baseline, up to Day 14	No
Secondary	Percentage Change From Baseline in Schirmer I Score	The investigator placed a paper strip on the eye under the lower lid and left it in place for 5 minutes. The Schirmer I Score was the length of the strip wetted by the tears (0-35 millimeters). A more positive percentage change indicates a greater amount of improvement.	Baseline, up to Day 14	No
Secondary	Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score	The subject completed a questionnaire and rated the intensity of five common dry eye symptoms. Intensity was rated on a visual analog scale from 0-100 (0=no symptoms to 100=severe symptoms). The GSI Total Score (0 to 500) is the sum of the five individual ratings. A more negative percentage change indicates a greater amount of improvement.	Baseline, up to Day 14	No
Secondary	Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score	For each of 5 common dry eye symptoms, the frequency (0-3) and intensity (0-100) scores were multiplied to obtain the symptom score (0-300). The 5 symptom scores were summed to obtain the Global Symptom Composite Index Score (0-1500). A more negative percentage change indicates a greater amount of improvement.	Baseline, up to Day 14	No
Secondary	Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating	The subject was asked on a questionnaire, "Please consider how your dry eyes feel when doing daily activities such as working on the computer, watching television, reading, and driving. Based on this, please rate the impact of your dry eye symptoms on your daily life," and responded on a 4-point scale from 0-3 (0=Absent to 3=Severe). Improved was defined as a change in score of <0 from baseline. Proportion is reported as a percentage of participants. A greater percentage of subjects reporting a lower score indicates an improvement.	Baseline, Up to Day 14	No