Progressive KeratoconusPhase 2/3CXLNCT00679666
Corneal Crosslinking in Keratoconus and Corneal Ectasia
A Phase 2/3 study testing Riboflavin in people with Progressive Keratoconus and Corneal Ectasia, run by Ohio State University at 2 sites in United States.
Trial summary
Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Progressive Keratoconus, Corneal Ectasia
- What is being tested?
- Riboflavin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to Oct 2010
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of keratoconus with documented progression over the previous 12 months.
- Diagnosis of corneal ectasia
- Must be able to complete all study visits.
Who cannot join
- Prior corneal surgery in keratoconus group
- Corneal scarring
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Medical Center
Columbus, Ohio, 43210
OSU Havener Eye Institute
Dublin, Ohio, 43016
About this study
Official title: Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.
Read the detailed description
After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.
- Conditions
- Progressive Keratoconus, Corneal Ectasia
- Being tested
- Riboflavin, Placebo
- Keywords
- keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
- Medical subject headings
- Keratoconus, Dilatation, Pathologic, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiboflavinDrug
Also called Vitamin B2
01% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes
PlaceboDrug
Drops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs.
| Study group | Role | What they receive |
|---|---|---|
| Sham treatment | Sham comparator | Subjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit. Receives: Drug: Placebo |
| Treatment Arm | Active comparator | After randomization, the active arm will have the collagen crosslinking intervention. Receives: Drug: Riboflavin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in keratometry
Measured: 3 months
Secondary outcomes (1)
best spectacle-corrected visual acuity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2010
- Study completionOct 2010
Why it stopped: Investigator no longer at university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive KeratoconusStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Keates, MD, Principal investigator, The Ohio State Univesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679666
- Sponsor's protocol ID
- 2008H0050,2008H0049
- Acronym
- CXL
- Status last verified
- Apr 2017
- First submitted
- 2 Apr 2008
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corneal Collagen Cross-Linking for the Treatment of Progressive Keratoconus and Corneal Ectasia
- ClinicalTrials.gov ID
- NCT00679666
- Acronym / sponsor ID
- CXL / 2008H0050,2008H0049
- Conditions
- Progressive Keratoconus, Corneal Ectasia
- Keywords
- keratoconus, ectasia, cross-linking, riboflavin, UVA light, cornea
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator no longer at university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 May 2008 (estimated)
- 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.
Prospective, randomized, single site to determine the safety and effectiveness of performing corneal collagen cross-linking (CXL) using riboflavin and UVA light in eyes progressive keratoconus or corneal ectasia.
Detailed description
After epithelial surface removal riboflavin drops are applied until there is saturation of the cornea.Then the UVA light is turned on to active the crosslinking process while drops are continued for the 30 minute of lamp use to replenish the riboflavin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham treatment | Sham comparator | Drug: PlaceboSubjects are randomized to control (sham) group or a treatment group with the control group crossed over to the treatment group at the 3 month visit. |
| Treatment Arm | Active comparator | Drug: RiboflavinAfter randomization, the active arm will have the collagen crosslinking intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of keratoconus with documented progression over the previous 12 months.
- Diagnosis of corneal ectasia
- Must be able to complete all study visits.
Key exclusion criteria (3 listed)
- Prior corneal surgery in keratoconus group
- Corneal scarring
- Pregnancy
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 |
|---|---|---|
| RiboflavinAlso: Vitamin B201% riboflavin drops for 30 minutes q 3 minutes before and during the procedure with exposure to UVA light for the second 30 minutes | Drug | Treatment Arm |
| PlaceboDrops are given q 3 minutes before (30 minutes) and during the procedure (30 minutes) but without the use of UVA light. No activation of cross linking occurs. | Drug | Sham treatment |
Primary outcome
change in keratometry
Time frame: 3 months
1 secondary outcome
best spectacle-corrected visual acuity
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
Related trials for Progressive Keratoconus
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
Enrolling by invitationPhase 1/2
Study of TN-001 Topical Eyedrops for Keratoconus
Keratoconus
RecruitingPhase 3
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Progressive Keratoconus
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.
Richard Keates, MD principal investigator
The Ohio State Univesity
2 sites 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 in people with Progressive Keratoconus and Corneal Ectasia, run by Ohio State University at 2 sites 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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 keratometry (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2017.