A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Glaukos Investigative Site
RECRUITING
Dothan
New Jersey
Glaukos Investigative Site
RECRUITING
Teaneck
Ohio
Glaukos Investigative Site
RECRUITING
Westerville
Contact Information
Primary
Marco Armijo
marmijo@glaukos.com
562-761-7965
Time Frame
Start Date: 2022-03-08
Estimated Completion Date: 2026-02
Participants
Target number of participants: 150
Treatments
Experimental: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Active_comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Active_comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Active_comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Active_comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Active_comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Active_comparator: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B
Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Sham_comparator: Placebo Group 2 / Cohort 2B
Sham Solution with no exposure to NXL System
Related Therapeutic Areas
Sponsors
Leads: Glaukos Corporation