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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: Completed Phase 3 study of Keratoconus, sponsored by Glaukos Corporation.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 236 participants
Start Date 2012-07
Est. Completion 2016-06
Phase Phase 3
Glaukos Corporation

33 total trials

What the finished NCT01344187 record still lists

NCT01344187 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 1,169-participant average among 21 other Keratoconus trials with a reported enrollment target (80% lower).

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 lists 10 locations in 10 states (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.

Similar trials for Keratoconus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01344187's enrollment target sits among peer trials

236 11th of 21 higher than 11 of 21 other Keratoconus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Keratoconus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01344187, the US trial registry maintained by the National Library of Medicine. NCT01344187 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.