KeratoconusPhase 2/3NCT07841470
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
A Phase 2/3 study testing Riboflavin 0.1% ophthalmic solution and pulsed light and Riboflavin 0.1% ophthalmic solution and non-pulsed light in people with Keratoconus and Corneal Ectasia, run by Price Vision Group at 1 site in United States.
Trial summary
This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia. Read more about this study
- Who is it for?
- Ages 10 to 90 years
- Conditions the study is for
- Keratoconus, Corneal Ectasia
- What is being tested?
- Riboflavin 0.1% ophthalmic solution and pulsed light and Riboflavin 0.1% ophthalmic solution and non-pulsed light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 30 Jun 2031
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of keratoconus or corneal ectasia
- Provision of written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Price Vision Group
Indianapolis, Indiana, 46260
Marianne Price, PhD, 317-814-2990, mprice@cornea.org
About this study
Official title: Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia: Randomized Comparison of Pulsed vs. Non-pulsed Treatment
This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia.
Read the detailed description
Subjects diagnosed with keratoconus or corneal ectasia are randomized to one of two corneal crosslinking light durations.
- Conditions
- Keratoconus, Corneal Ectasia
- Being tested
- Riboflavin 0.1% ophthalmic solution and pulsed light, Riboflavin 0.1% ophthalmic solution and non-pulsed light
- Keywords
- crosslinking, keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin 0.1% ophthalmic solution and pulsed lightCombination product
Use of riboflavin 0.1% eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes
Riboflavin 0.1% ophthalmic solution and non-pulsed lightCombination product
Use of riboflavin 0.1% eye drops and non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes
| Study group | Role | What they receive |
|---|---|---|
| Pulsed | Active comparator | Treatment with 0.1% riboflavin eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes Receives: 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 Receives: Combination Product: Riboflavin 0.1% ophthalmic solution and non-pulsed light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum keratometry
assessed with corneal tomography
Measured: 6 months
Secondary outcomes (2)
change in corrected distance visual acuity
assessed with Snellen chart
Measured: 6 months
change in uncorrected distance visual acuity
assessed with Snellen chart
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Oct 2025
- Primary completion31 Dec 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Price Vision Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis Price, MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841470
- Sponsor's protocol ID
- 2025-001
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD may be shared upon individual request to the study contact