Trials / Completed
CompletedNCT01344187
Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus
A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 236 (actual)
- Sponsor
- Glaukos Corporation · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | riboflavin solution | 0.12% riboflavin ophthalmic solution |
| DRUG | placebo solution | 0.0% riboflavin ophthalmic solution |
| DEVICE | KXL System | 30 mW/cm2 |
Timeline
- Start date
- 2012-07-01
- Primary completion
- 2015-06-01
- Completion
- 2016-06-01
- First posted
- 2011-04-29
- Last updated
- 2021-04-26
Locations
10 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01344187. Inclusion in this directory is not an endorsement.