Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

Phase 1

Recruiting

• Conditions: Progressive Keratoconus
• Interventions: Combination Product: NXL Energy 3; Combination Product: NXL Energy 1; Combination Product: NXL Energy 2; Combination Product: Sham Treatment

• Registration Number: NCT05314738
• Lead Sponsor: Glaukos Corporation

Brief Summary

Clinical Trial to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects with Keratoconus.

Detailed Description

This is a a dose ranging, multi-center, sham-controlled study to evaluate the safety and efficacy of epithelium-on corneal collagen cross-linking. The study will evaluate safety and efficacy in subjects who have keratoconus.

Study Timeline

• Study Start: 2022-03-08
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-08
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1	NXL Energy 3	Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A	NXL Energy 1	Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A	NXL Energy 2	Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A	NXL Energy 3	Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B	NXL Energy 1	Riboflavin Solution + Exposure to NXL system to achieve total energy level 1
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B	NXL Energy 2	Riboflavin Solution + Exposure to NXL system to achieve total energy level 2
Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B	NXL Energy 3	Riboflavin Solution + Exposure to NXL system to achieve total energy level 3
Placebo Group 2 / Cohort 2B	Sham Treatment	Sham Solution with no exposure to NXL System

Primary Outcome Measures

Name	Time	Method
Topography	12 Months	Change in Kmax topography value from baseline

Secondary Outcome Measures

Name	Time	Method
Distance Uncorrected Visual Acuity (UCVA)	12 Months	Change in Distance UCVA

Trial Locations

Locations (1)

Glaukos Investigative Site; 🇺🇸 Westerville, Ohio, United States