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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:
Sponsor: Alcon Research

Current Primary Outcome:

• Change From Baseline in Lissamine Green Staining (LGS) Total Score at Day 7 [ Time Frame: 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 [ Time Frame: 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.

Original Primary Outcome:

• Change from baseline in lissamine green staining total score [ Time Frame: Day 7 ]
• Change from baseline in global symptom frequency total score [ Time Frame: Day 7 ]

Current Secondary Outcome:

• Change From Baseline in LGS Total Score at Day 14 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome:

Information By: Alcon Research

Dates:
Date Received: June 9, 2011
Date Started: July 2011
Date Completion:
Last Updated: May 20, 2013
Last Verified: May 2013