Clinical trial

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

NCT05314738

Name

NXL-101-KCON

Description

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

Trial arms

Trial start

2022-03-08

Estimated PCD

2025-01-01

Trial end

2025-08-01

Status

Recruiting

Phase

Early phase I

Treatment

NXL Energy 1

Riboflavin drops + NXL System to Total Energy Level 1

Arms:

Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2B

NXL Energy 2

Riboflavin drops + NXL System to Total Energy Level 2

Arms:

Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2B

NXL Energy 3

Riboflavin drops + NXL System to Total Energy Level 3

Arms:

Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2A, Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2B

Sham Treatment

Sham Drops and No exposure to NXL system

Arms:

Placebo Group 2 / Cohort 2B

Size

150

Primary endpoint

Topography

12 Months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

Updated at

2023-07-27

1 organization

3 products

1 indication

Product

Indication

Organization

Product

Product