CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 201 enrolled
Drug / intervention
Test Article A +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03442751
NCT03442751Phase 3Completed
CompareCT.gov

A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus

Glaukos Corporation·interventional·Posted Feb 22, 2018·Updated Jan 30, 2024

In Brief

A Phase 3 clinical trial evaluating Test Article A, Test Article B, and 2 other interventions for Progressive Keratoconus. Completed, enrolled 201 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProgressive Keratoconus
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartApr 6, 2018
Primary CompletionNov 1, 2019
Study CompletionAug 10, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 8.4 years ago

Interventions

Test Article Adrug

Riboflavin Ophthalmic Solution A

Test Article Bdrug

Riboflavin Ophthalmic Solution B

Placebodrug

Placebo Vehicle of Test Article

KXL medical device systemdevice

Mock UVA light source

KXL medical device systemdevice

Cross-linking UVA light source