Clinical TrialID 6702
Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus
NCT01643226
Keratoconus
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 6702
- Evidence Id
- 6702
- Core Evidence Id
- 6702
- Source Clinical Trial Id
- 6689
- Herb2 Clinical Trial Id
- HBCT006689
- Nct Id
- NCT01643226
- Title
- Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus
- Status
- Completed
- Phase
- Phase 3
- Study Result
- No
- Study Condition
- Keratoconus
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: riboflavin solution|DRUG: placebo solution|DEVICE: KXL System
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Single
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child, Adult, Older_Adult
- Enrollment
- 230
- Outcome Measure
- Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group, baseline to 6 months
- Sponsor Collaborator
- Glaukos Corporation
- Funded By
- INDUSTRY
- Location
- Gordon -Weiss Vision Institute, San Diego, California, 92122, United States|Price Vision Group, Indianapolis, Indiana, 46260, United States|Durrie Vision, Overland Park, Kansas, 66211, United States|Cornea & Laser Eye Institute; Hersh Vision Group, Teaneck, New Jersey, 07666, United States|Columbia University Harkness Eye Institute, New York, New York, 10032, United States|Cleveland Clinic Cole Eye Institute, Cleveland, Ohio, 44195, United States|UPMC Eye Center, Pittsburgh, Pennsylvania, 15213, United States|See Clearly Vision, McLean, Virginia, 22102, United States
- Other Id
- KXL-002
- Start Date
- 2012-07
- Primary Completion Date
- 2015-07
- Completion Date
- 2016-09
- First Posted
- 2012-07-18
- Results First Posted
- Last Update Posted
- 2021-04-26
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01643226
- Title Cn
- Title En
- Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus
- Bilingual Status
- semi_complete