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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sodium Hyaluronate<br>Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days | Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%<br> <br> |
| Placebo Comparator: Vehicle<br>Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days | Other: Vehicle<br>* Inactive ingredients used as run-in and placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eyes, Ocular discomfort