Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms

Phase 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®; Drug: Sodium hyaluronate

• Registration Number: NCT00761202
• Lead Sponsor: Allergan

Brief Summary

This study evaluates the performance and acceptance of Optive versus Hylocomod eyedrops, when administered for one month to patients with mild to moderate dry eye symptoms, with and without contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-29
• Results First Submitted: 2010-01-12
• Results First Submitted QC: 2010-01-12
• Results First Posted: 2010-02-04
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 18 years or over
• Contact lens wearer, spectacle wearer or non-spectacle wearer
• Mild to severe dry eye symptoms, defined as OSDI score 13 to 100
• Mild to moderate conjunctival staining in each eye and/or mild to moderate corneal staining in each eye
• Best corrected visual acuity of 6/9 in each eye

Exclusion Criteria

• Previously used Hylocomod or Optive eyedrops
• Systemic allergy or eye allergy
• Systemic disease which might have an ocular component and/or interfere with contact lens wear
• Autoimmune disease which might have an ocular component and/or interfere with contact lens wear
• Systemic medication which might have eye side effects and or interfere with contact lens wear
• Eye infection or use of eye medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®	Optive Eyedrops
2	Sodium hyaluronate	Hylocomod Eyedrops

Primary Outcome Measures

Name	Time	Method
Conjunctival Staining by Lissamine Green	week 1, month 1	Percentage of cases of limbal staining by lissamine green at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)

Secondary Outcome Measures

Name	Time	Method
Corneal Staining by Fluorescein	week 1, month 1	Percentage of cases of limbal staining by sodium fluorescein at each point on a five point scale (0 = None, 1 = Trace, 2 = Mild, 3 = Moderate, 4 = Severe)
Conjunctival Hyperaemia	week 1, month 1	Percentage of conjunctival response reported in terms of limbal hyperaemia for the worst responses over the area at each point on a five point scale (0=clear/white conjunctiva, 1=slight redness, 2=Mild redness, 3=Moderate redness, 4=Severe redness)
Ocular Comfort and Ocular Symptoms on Visual Analogue Scale	week 1, month 1	Mean comfort judged on a 100 point visual analogue scale (0=Very Poor, 100=Excellent)
Daily Eyedrop Usage	Month 1	Average daily eyedrop use
Lipid Layer Pattern Assessment	Week 1, month 1	Lipid layer thickness as determined by lipid layer mixing pattern. A high mixing pattern = thick lipid layer.