KeratoconusPhase 2/3NCT03922542
Comparison of Standard vs. Accelerated Corneal Crosslinking
A Phase 2/3 study testing riboflavin 0.1% in people with Keratoconus and Ectasia Corneal, run by Price Vision Group at 1 site in United States.
Trial summary
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Keratoconus, Ectasia Corneal
- What is being tested?
- riboflavin 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 30 Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Documented keratoconus or ectasia after refractive surgery
Who cannot join
- Insufficient corneal thickness
- Ocular condition that may predispose the eye to complications
- History of chemical injury or delayed epithelial healing
- Condition that would interfere with or prolong epithelial healing
- Known sensitivity to treatment medications
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
- Conditions
- Keratoconus, Ectasia Corneal
- Being tested
- riboflavin 0.1%
- 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%Combination product
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
Riboflavin 0.1%Combination product
Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Accelerated | Active comparator | Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes Receives: Combination Product: riboflavin 0.1% |
| Standard | Active comparator | Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes Receives: Combination Product: Riboflavin 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in maximum keratometry
assessed by 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 posted22 Apr 2019
- Study start16 Apr 2019
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Price Vision Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis W Price, Jr., MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922542
- Sponsor's protocol ID
- 2019-003
- Status last verified
- Sep 2026
- First submitted
- 17 Apr 2019
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Price MO, Fairchild K, Feng MT, Price FW Jr. Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia. Ophthalmology. 2018 Apr;125(4):505-511. doi: 10.1016/j.ophtha.2017.10.034. Epub 2017 Dec 2.
PubMed 29203068Lautert J, Doshi D, Price FW Jr, Price MO. Corneal Epithelial Remodeling After Standard Epithelium-off Corneal Cross-linking in Keratoconic Eyes. J Refract Surg. 2018 Jun 1;34(6):408-412. doi: 10.3928/1081597X-20180402-03.
PubMed 29889294Price MO, Feng MT, Price FW Jr. Patient satisfaction with epithelium-off corneal crosslinking. J Cataract Refract Surg. 2018 Mar;44(3):323-328. doi: 10.1016/j.jcrs.2017.12.023. Epub 2018 Mar 28.
PubMed 29605283