Phase 2
Completed N=137
Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT00611403 ↗
Enrolled (actual)
137
Serious AEs
1.5%
Results posted
Dec 2011
Primary outcomePrimary: Percentage of Patients With Clinical Success at Month 6 — 64.3; 58.1 Percentage of Patients
Summary
This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Clinical Success at Month 6 |
64.3; 58.1 | — |
| SECONDARY Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6 |
28095.7; 26069.5; 901.6; 1346.6; 26489.9; 27480.6 | — |
| SECONDARY Change From Baseline in Goblet Cell Density of the Eyes at Month 6 |
60.9; 59.7; 30.9; -3.1; 68.4; 79.2 | — |
Eligibility Criteria
Inclusion Criteria
- Patient is scheduled for bilateral LASIK surgery
- Patient is in good general health
- Eye glasses prescription of -1 to -8
Exclusion Criteria
- Significant Dry Eye
- Presence of eye disease
- Uncontrolled systemic disease
Data sourced from ClinicalTrials.gov (NCT00611403). 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.