NCT05314738

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

A Dose Ranging, Multicenter, Sham-Controlled Study to Evaluate the Safety and Efficacy of Corneal Cross-linking in Subjects With Keratoconus

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Glaukos Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Keratoconus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	NXL Energy 1	Riboflavin drops + NXL System to Total Energy Level 1
COMBINATION_PRODUCT	NXL Energy 2	Riboflavin drops + NXL System to Total Energy Level 2
COMBINATION_PRODUCT	NXL Energy 3	Riboflavin drops + NXL System to Total Energy Level 3
COMBINATION_PRODUCT	Sham Treatment	Sham Drops and No exposure to NXL system

Timeline

• Start date: 2022-03-08
• Primary completion: 2025-08-01
• Completion: 2026-02-01
• First posted: 2022-04-06
• Last updated: 2024-07-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study