CompletedInterventionalPhase 4Updated Oct 31, 2011
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms | NCT00761202 | Trialant
CompletedInterventionalPhase 4Updated Nov 19, 2013
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
ClinicalTrials.gov ID
NCT00761202
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 4
Enrollment
50Actual
Last Update Posted
Nov 19, 2013Estimated
Start Date
Aug 2007
Primary Completion Date
Jun 2008Actual
Completion Date
Jun 2008Actual
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.
Dry Eye Syndromes
A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE®
Sodium hyaluronate
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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