NCT01382225 - Sodium Hyaluronate Ophthalmic Solution, 0.18% for Treatment of Dry Eye Syndrome | Crick

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,936

Conditions

Dry Eye Syndrome

Interventions

Sodium Hyaluronate Ophthalmic Solution, 0.18%DRUG

VehicleOTHER

Inactive ingredients used as run-in and placebo comparator

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, Day 7

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.