Evaluating corneal cross-linking for keratoconus treatment
A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
This study is testing a new treatment for keratoconus to see if different energy levels of corneal cross-linking can help improve vision in people with this condition.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Glaukos Corporation Industry-sponsored |
| Locations | 3 sites (Dothan, Alabama and 2 other locations) |
| Trial ID | NCT05314738 on ClinicalTrials.gov |
What this trial studies
This clinical trial assesses the safety and efficacy of epithelium-on corneal collagen cross-linking in patients diagnosed with progressive keratoconus. It is a dose-ranging, multi-center, sham-controlled study designed to determine the effectiveness of different energy levels of the treatment. Participants will be monitored for their ability to follow instructions and attend follow-up visits, ensuring comprehensive data collection on the treatment's impact.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with keratoconus who can provide informed consent and comply with study protocols.
Not a fit: Patients with ocular conditions other than keratoconus or those with known allergies to the treatment components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve vision and quality of life for patients with progressive keratoconus.
How similar studies have performed: Previous studies on corneal cross-linking have shown promising results, indicating that this approach is both tested and has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provide written informed consent * Ability to hold gaze sufficiently stable for study testing * Willingness and ability to follow all instructions and comply with schedule for follow-up visits * Have a diagnosis of keratoconus Exclusion Criteria: * Known allergy or sensitivity to the test articles or components * Any disease causing abnormal topography other than keratoconus * Prior or current ocular condition (other than keratoconus) in the study eye that may predispose the eye for future complications
Where this trial is running
Dothan, Alabama and 2 other locations
- Glaukos Investigative Site — Dothan, Alabama, United States (Recruiting)
- Glaukos Investigative Site — Teaneck, New Jersey, United States (Recruiting)
- Glaukos Investigative Site — Westerville, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Marco Armijo
- Email: marmijo@glaukos.com
- Phone: 562-761-7965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.