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NCT01893359 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism
A Phase 1 study, sponsored by Glaukos Corporation.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT01893359: Clinical Trial Phase 1 study, sponsored by Glaukos Corporation.
NCT01893359 is a Phase 1 study that was terminated before completion, run by Glaukos Corporation. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01893359, a Phase 1 study, was terminated before completion, sponsored by Glaukos Corporation.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study Summary
The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution), as compared to LASIK alone.
Primary Outcome
The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.
Interventions
- DRUG riboflavin ophthalmic solution, 0% dextran
- DEVICE UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
- DEVICE UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
- PROCEDURE Laser-assisted in situ keratomileusis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-08 |
| Est. Completion | 2016-04 |
| Phase | Phase 1 |
Why NCT01893359 stopped before completion
NCT01893359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which riboflavin ophthalmic solution, 0% dextran is the first listed.
NCT01893359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01893359 about?
NCT01893359 is a clinical study titled "Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism". The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed...
What is the current status of trial NCT01893359?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2013-08. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01893359?
The interventions under investigation include: riboflavin ophthalmic solution, 0% dextran (DRUG), UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA) (DEVICE), UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off) (DEVICE), Laser-assisted in situ keratomileusis (PROCEDURE).
Who is sponsoring clinical trial NCT01893359?
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 NCT01893359's enrollment target sits among peer trials
2 2000th of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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