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NCT03442751 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus
A Phase 3 study, sponsored by Glaukos Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 201
- Enrollment target
NCT03442751: Completed Phase 3 study, sponsored by Glaukos Corporation.
NCT03442751 is a Phase 3 study that has completed, run by Glaukos Corporation. The registered enrollment target is 201 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03442751, a Phase 3 study, has completed, sponsored by Glaukos Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 201 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the need to remove the epithelium, the outer most layer of the cornea.
Primary Outcome
Mean difference of at least 1 diopter in Kmax change from baseline to Month 6 between treatment groups
Interventions
- DRUG Placebo
- DRUG Test Article A
- DRUG Test Article B
- DEVICE KXL medical device system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 201 participants |
| Start Date | 2018-04-06 |
| Est. Completion | 2020-08-10 |
| Phase | Phase 3 |
What the finished NCT03442751 record still lists
NCT03442751 is an interventional study that assigns participants to a tested intervention. The registered 201 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03442751 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03442751 about?
NCT03442751 is a clinical study titled "Study to Evaluate the Safety and Efficacy of Epi-on Corneal Cross-linking in Eyes With Progressive Keratoconus". To evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking (CXL) in impeding the progression of, and/or reducing corneal curvature (Kmax) in eyes with progressive keratoconus. Epithelium-on CXL uses a formulation that allows the riboflavin to penetrate the cornea without the...
What is the current status of trial NCT03442751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 201 participants. The study started on 2018-04-06. Estimated completion is 2020-08-10.
What interventions are being tested in trial NCT03442751?
The interventions under investigation include: Placebo (DRUG), Test Article A (DRUG), Test Article B (DRUG), KXL medical device system (DEVICE).
Who is sponsoring clinical trial NCT03442751?
This trial is sponsored by Glaukos Corporation, which has 33 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03442751's enrollment target sits among peer trials
201 1353rd of 2000 higher than 648 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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