Phase 2
Completed N=621
Study of Cyclosporine in Post-LASIK Patients
Laser In Situ Keratomileusis
Source: ClinicalTrials.gov NCT00991458 ↗
Enrolled (actual)
621
Serious AEs
0.8%
Results posted
Jul 2013
Primary outcomePrimary: Time to Cure — 189.0; 194.0; 189.0 Days
Summary
This study will evaluate the safety and efficacy of Cyclosporine 0.005% and 0.010% eye drops administered twice daily before and following LASIK surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Cure |
189.0; 194.0; 189.0 | — |
| SECONDARY Time to Worst Outcome Post-LASIK Surgery in Tear Film Assessment |
11.2; 12.0; 11.5 | — |
| SECONDARY Percentage of Patients With Cumulative Poor Vision |
15.0; 18.7; 19.0; 17.9; 22.5; 23.9 | — |
| SECONDARY Worst Outcome Post-LASIK Surgery in Reading Speed Assessment |
173.0; 173.7; 167.4 | — |
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
- Previous use of RESTASIS®
Data sourced from ClinicalTrials.gov (NCT00991458). 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.