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

Phase 3

Completed

• Conditions: Dry Eye Syndrome
• Interventions: Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%; Other: Vehicle

• Registration Number: NCT01382225
• Lead Sponsor: Alcon Research

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2011-07
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-05
• Results First Submitted: 2013-05-20
• Results First Submitted QC: 2013-05-20
• Last Update Submitted: 2013-05-20
• Results First Posted: 2013-07-08
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1936

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Hyaluronate	Sodium Hyaluronate Ophthalmic Solution, 0.18%	Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
Vehicle	Vehicle	Inactive ingredients, 1-2 drops instilled in each eye 3-6 times a day for 14 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7	Baseline, 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.
Change From Baseline in Global Symptom Frequency (GSF) Total Score at Day 7	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in LGS Total Score at Day 14	Baseline, 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.
Change From Baseline in GSF Total Score at Day 14	Baseline, 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.
Percentage Change From Baseline in Corneal Fluorescein Staining (CFS) Total Score	Baseline, up to Day 14	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.
Percentage Change From Baseline in Schirmer I Score	Baseline, up to Day 14	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.
Percentage Change From Baseline in Global Symptom Intensity (GSI) Total Score	Baseline, up to Day 14	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.
Percentage Change From Baseline in Global Symptom Composite Index (GSCI) Score	Baseline, up to Day 14	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.
Proportion of Improved Scores on the Global Impact on Dry Eye Syndrome on Daily Life (GIDL) Rating	Baseline, Up to Day 14	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.