Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia

NCT07841470 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025-001
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia.

Conditions

Keratoconus; Corneal Ectasia

Keywords

crosslinking; keratoconus

Outcome Measures

Primary Outcomes (1)

• Change in maximum keratometry

  assessed with corneal tomography

  6 months

Secondary Outcomes (2)

• change in corrected distance visual acuity

  6 months

• change in uncorrected distance visual acuity

  6 months

Study Arms (2)

Pulsed

ACTIVE COMPARATOR

Treatment with 0.1% riboflavin eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes

Combination Product: Riboflavin 0.1% ophthalmic solution and pulsed light

Non-pulsed

ACTIVE COMPARATOR

Treatment with 0.1% riboflavin eye drops non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes

Combination Product: Riboflavin 0.1% ophthalmic solution and non-pulsed light

Interventions

Riboflavin 0.1% ophthalmic solution and pulsed light COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes

Pulsed

Riboflavin 0.1% ophthalmic solution and non-pulsed light COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes

Non-pulsed

Eligibility Criteria

• Age: 10 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of keratoconus or corneal ectasia
• Provision of written informed consent

You may not qualify if:

• Previous ocular condition in the study eye that may predispose for future complications including history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
• Clinically significant corneal scarring in the proposed treatment zone
• History of chemical injury or delayed epithelial healing in the study eye
• Known sensitivity to study medication
• A current condition, including clinically significant dry eyes or use of medications know to induce dry eye symptoms, that, in the treating physician's opinion, would interfere with or prolong epithelial healing
• Pregnancy (including plan to become pregnant) or lactation during the course of the study

Sponsors & Collaborators

• Price Vision Group: lead

Study Sites (1)

Price Vision Group

Indianapolis, Indiana, 46260, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Interventions

Riboflavin; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Francis Price, MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marianne Price, PhD

CONTACT

317-814-2990; mprice@cornea.org

Francis Price, MD

CONTACT

317-814-2823; fprice@pricevisiongroup.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 25, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)