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NCT01344187 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus
A Phase 3 study of Keratoconus, sponsored by Glaukos Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 236
- Enrollment target
- 10
- Study locations
NCT01344187 is a Phase 3 study of Keratoconus that has completed, run by Glaukos Corporation. The registered enrollment target is 236 participants, below the 1,169-participant average among 21 other Keratoconus trials with a reported enrollment target (80% lower). The trial reports 10 study locations across 10 states.
The verdict
NCT01344187, a Phase 3 study of Keratoconus, has completed, sponsored by Glaukos Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 236 participants
- Enrollment target
- 10
- Study locations
Study 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 Studied
Interventions
- DRUG riboflavin solution
- DRUG placebo solution
- DEVICE KXL System
Study Locations (10)
California
- UC Irvine Department of Ophthalmology - Irvine
Florida
- Bascolm Palmer Eye Institute - Miami
Georgia
- Emory Eye Center - Atlanta
Massachusetts
- Ophthalmic Consultants of Boston - Waltham
Nebraska
- Kugler Vision - Omaha
New Jersey
- Pinceton Eye Goup - Princeton
Ohio
- Comprehensive Eye Care of Central Ohio - Westerville
South Carolina
- Medical University of South Carolina Storm Eye Institute, Magill Vision Center - Mt. Pleasant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01344187
The ClinicalTrials.gov registry entry for NCT01344187 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,169-participant average among 21 other Keratoconus trials with a reported enrollment target (80% lower). The listed sponsor is Glaukos Corporation, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Keratoconus appearing as the primary indexed condition, and to 3 interventions - of which riboflavin solution is the first listed.
NCT01344187 reports 10 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01344187 about?
NCT01344187 is a clinical study titled "Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus". 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.
What is the current status of trial NCT01344187?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2012-07. Estimated completion is 2016-06.
What conditions does trial NCT01344187 study?
This clinical trial studies the following conditions: Keratoconus.
What interventions are being tested in trial NCT01344187?
The interventions under investigation include: riboflavin solution (DRUG), placebo solution (DRUG), KXL System (DEVICE).
Who is sponsoring clinical trial NCT01344187?
This trial is sponsored by Glaukos Corporation, which has 33 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01344187 being conducted?
This trial has 10 study locations across California, Florida, Georgia, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.