Phase 4 N=50 Randomized Single-blind Treatment

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

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT00761202 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2010

Primary outcome: Primary: Conjunctival Staining by Lissamine Green — 50.0; 53.8; 17.5; 15.4 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: A sterile solution containing sodium carboxymethylcellulose and glycerin, preserved with PURITE® (Drug); Sodium hyaluronate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Allergan
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Conjunctival Staining by Lissamine Green	50.0; 53.8; 17.5; 15.4; 17.5; 25.0	—
SECONDARY Corneal Staining by Fluorescein	45.0; 57.7; 25.0; 15.4; 15.0; 25.0	—
SECONDARY Conjunctival Hyperaemia	5.0; 3.8; 75.0; 59.6; 17.5; 36.5	—
SECONDARY Ocular Comfort and Ocular Symptoms on Visual Analogue Scale	67.05; 58.81; 63.20; 68.21; 57.15; 63.38	—
SECONDARY Daily Eyedrop Usage	3.7; 3.3	—
SECONDARY Lipid Layer Pattern Assessment	4.50; 5.50; 3.00; 5.00	—

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.

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
Eye infection or use of eye medication

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Data sourced from ClinicalTrials.gov (NCT00761202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.