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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
- ClinicalTrials.gov ID
- NCT03922542
- Acronym / sponsor ID
- 2019-003
- Conditions
- Keratoconus, Ectasia Corneal
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Price Vision GroupIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated | Active comparator | Combination Product: riboflavin 0.1%Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes |
| Standard | Active comparator | Combination Product: Riboflavin 0.1%Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Documented keratoconus or ectasia after refractive surgery
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| riboflavin 0.1%Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes | Combination product | Accelerated |
| Riboflavin 0.1%Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes | Combination product | Standard |
Primary outcome
Change in maximum keratometry
Time frame: 6 months
assessed by corneal tomography
2 secondary outcomes
Change in corrected distance visual acuity
Time frame: 6 months
Change in uncorrected distance visual acuity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 29203068Price 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.
- Background: PubMed 29889294Lautert 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.
- Background: PubMed 29605283Price 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis W Price, Jr., MD principal investigator
Price Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in maximum keratometry (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03922542, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.