KeratoconusPhase 4NCT07629557
Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus
A Phase 4 study testing Riboflavin Ophthalmic Solutions and UV-A Irradiation System in people with Keratoconus, run by Glaukos Corporation at 1 site in United States.
Trial summary
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Riboflavin Ophthalmic Solutions and UV-A Irradiation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Provide written informed consent
- Willing and able to comply with study instructions and follow-up visits
- Diagnosis of keratoconus in each eye
Who cannot join
- Known allergy or sensitivity to study medications
- History of corneal disease
- Prior corneal cross-linking in either eye
- Pregnant, nursing, or planning pregnancy during the study period
- Participated in other investigational drug or device trial within 30 days 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
Glaukos Investigative Site
Westerville, Ohio, 43082
Study Director, MD, 949-739-8749, ClinicalResearch@glaukos.com
About this study
Official title: Single-arm, Multi-center Study to Evaluate the Safety and Feasibility of Bilateral Epithelium-on Corneal Collagen Cross-linking With Epioxa™ HD/Epioxa™ and UV-A Irradiation Using the O2n™ System and Supplemental Oxygen Using the Boost Goggles® in Subjects With Keratoconus
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.
- Conditions
- Keratoconus
- Being tested
- Riboflavin Ophthalmic Solutions, UV-A Irradiation System
- Keywords
- Keratoconus, Corneal Cross-linking
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riboflavin Ophthalmic SolutionsDrug
Riboflavin Ophthalmic Solutions
UV-A Irradiation SystemDevice
O2n UV-A Irradiation System
| Study group | Role | What they receive |
|---|---|---|
| Epioxa™ HD/Epioxa™ and UV-A Irradiation | Experimental | Epioxa™ HD/Epioxa™ and UV-A Irradiation using the O2n™ System and Supplemental Oxygen using the Boost Goggles® Receives: Drug: Riboflavin Ophthalmic Solutions; Device: UV-A Irradiation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful completion of bilateral epithelium-on corneal collagen cross-linking.
Portion of subjects that the Investigator completed bilateral epithelium-on corneal collagen cross-linking treatment on the same day.
Measured: Approximately 2.5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start11 May 2026
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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.
- More trials run by Glaukos CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629557
- Sponsor's protocol ID
- GLK-202-05
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm, Multi-center Study to Evaluate the Safety and Feasibility of Bilateral Epithelium-on Corneal Collagen Cross-linking With Epioxa™ HD/Epioxa™ and UV-A Irradiation Using the O2n™ System and Supplemental Oxygen Using the Boost Goggles® in Subjects With Keratoconus
- ClinicalTrials.gov ID
- NCT07629557
- Acronym / sponsor ID
- GLK-202-05
- Conditions
- Keratoconus
- Keywords
- Keratoconus, Corneal Cross-linking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Jun 2026 (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.
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epioxa™ HD/Epioxa™ and UV-A Irradiation | Experimental | Drug: Riboflavin Ophthalmic Solutions, Device: UV-A Irradiation SystemEpioxa™ HD/Epioxa™ and UV-A Irradiation using the O2n™ System and Supplemental Oxygen using the Boost Goggles® |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Provide written informed consent
- Willing and able to comply with study instructions and follow-up visits
- Diagnosis of keratoconus in each eye
Key exclusion criteria (5 listed)
- Known allergy or sensitivity to study medications
- History of corneal disease
- Prior corneal cross-linking in either eye
- Pregnant, nursing, or planning pregnancy during the study period
- Participated in other investigational drug or device trial within 30 days of the study
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 Ophthalmic SolutionsRiboflavin Ophthalmic Solutions | Drug | Epioxa™ HD/Epioxa™ and UV-A Irradiation |
| UV-A Irradiation SystemO2n UV-A Irradiation System | Device | Epioxa™ HD/Epioxa™ and UV-A Irradiation |
Primary outcome
Successful completion of bilateral epithelium-on corneal collagen cross-linking.
Time frame: Approximately 2.5 Months
Portion of subjects that the Investigator completed bilateral epithelium-on corneal collagen cross-linking treatment on the same day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Keratoconus
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Proof-of-Concept for a Novel Optical Aperture Contact Lens in Presbyopia and Keratoconus
Keratoconus, Presbyopia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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.
Study Director study director
Glaukos Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Riboflavin Ophthalmic Solutions and UV-A Irradiation System in people with Keratoconus, run by Glaukos Corporation 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Jun 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (949-739-8749, ClinicalResearch@glaukos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of bilateral epithelium-on corneal collagen cross-linking. (time frame: Approximately 2.5 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 5 Jun 2026.