Phase 4
Completed N=50
Performance and Acceptance of Optive Versus Hylocomod Eyedrops in Patients With Dry Eye Symptoms
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT00761202 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Conjunctival Staining by Lissamine Green — 50.0; 53.8; 17.5; 15.4 Percentage of Participants
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.
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 | — |
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
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. Informational only — not medical advice.