Trials / Withdrawn
WithdrawnNCT01643252
Safety and Efficacy Study for Corneal Collagen Cross-Linking in Eyes With Corneal Ectasia After Refractive Surgery
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 Corneal Ectasia After Refractive Surgery
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (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.
Detailed description
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: 0.12% riboflavin ophthalmic solution with the KXL system | Subjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by irradiation with the KXL system at 30mW/cm\^2 for 4 minutes |
| DRUG | placebo: 0.0% riboflavin ophthalmic solution with the KXL system | Subjects will receive 0.0% riboflavin ophthalmic solution (placebo) followed by irradiation with the KXL system at 30mW/cm\^2 for 4 minutes |
Timeline
- Start date
- 2012-07-01
- First posted
- 2012-07-18
- Last updated
- 2021-04-26
Source: ClinicalTrials.gov record NCT01643252. Inclusion in this directory is not an endorsement.