Health TrialsbyHealthPanel

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

ConditionProgressive Keratoconus
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGlaukos Corporation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NXL Energy 1

    Combination product

    Riboflavin drops + NXL System to Total Energy Level 1

  • NXL Energy 2

    Combination product

    Riboflavin drops + NXL System to Total Energy Level 2

  • NXL Energy 3

    Combination product

    Riboflavin drops + NXL System to Total Energy Level 3

  • Sham Treatment

    Combination product

    Sham Drops and No exposure to NXL system

Treatment groups

150 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 1 / Cohort 1Experimental treatment 1 intervention
Group B: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2AActive comparator 1 intervention
Group C: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2AActive comparator 1 intervention
Group D: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2AActive comparator 1 intervention
Group E: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 3 / Cohort 2BActive comparator 1 intervention
Group F: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 4 / Cohort 2BActive comparator 1 intervention
Group G: Riboflavin Ophthalmic Solution and UV-A Irradiation Group 5 / Cohort 2BActive comparator 1 intervention
Group H: Placebo Group 2 / Cohort 2BSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Topography

Change in Kmax topography value from baseline

Time frame
12 Months

Secondary outcomes

1

Distance Uncorrected Visual Acuity (UCVA)

Change in Distance UCVA

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Glaukos Corporation

Lead sponsor

Source ClinicalTrials.gov
Apply now