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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: Sodium Hyaluronate Ophthalmic Solution, 0.18%; Other: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 1936
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Michela Montecchi-Palmer, BS, Alcon Research

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: June 9, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (Estimate): June 27, 2011

Study Record Updates

• Last Update Posted (Estimate): July 8, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Dry eyes; Ocular discomfort
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Pharmaceutical Solutions; Viscosupplements; Ophthalmic Solutions; Hyaluronic Acid
• Other Study ID Numbers: C-09-045