KeratoconusPhase 2NCT07400952
Placebo-controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus
A Phase 2 study testing GLK-221 Ophthalmic Solution in people with Keratoconus, run by Glaukos Corporation at 1 site in United States.
Trial summary
Multi-center, parallel-group, placebo-controlled trial designed to assess the safety and efficacy of twice-daily topically administered GLK-221 Ophthalmic Solution in subjects with keratoconus. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- GLK-221 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2025to Apr 2027
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Be ≥ 18 and ≤ 55 years of age
- Diagnosis of keratoconus in the study eye
Who cannot join
- Pregnant, lactating or planning a pregnancy
- Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial
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 Clinical Study Site
Westerville, Ohio, 43082
Study Manager, 949-739-8749
About this study
Official title: Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus
Multi-center, parallel-group, placebo-controlled trial designed to assess the safety and efficacy of twice-daily topically administered GLK-221 Ophthalmic Solution in subjects with keratoconus.
- Conditions
- Keratoconus
- Being tested
- GLK-221 Ophthalmic Solution, Placebo Ophthalmic Solution
- Keywords
- Keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLK-221 Ophthalmic SolutionDrug
GLK-221 Ophthalmic Solution administered twice daily to both eyes
Placebo Ophthalmic SolutionDrug
Placebo Ophthalmic Solution administered twice daily to both eyes
| Study group | Role | What they receive |
|---|---|---|
| GLK-221 Ophthalmic Solution | Experimental | GLK-221 Ophthalmic Solution administered topically twice daily to both eyes Receives: Drug: GLK-221 Ophthalmic Solution |
| Placebo | Placebo comparator | Placebo Ophthalmic Solution administered topically twice daily to both eyes Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in maximum corneal curvature
Mean change from baseline in maximum corneal curvature
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start23 Dec 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glaukos Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, MD, Study director, Glaukos Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400952
- Sponsor's protocol ID
- GLK-221-01
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus
- ClinicalTrials.gov ID
- NCT07400952
- Acronym / sponsor ID
- GLK-221-01
- Conditions
- Keratoconus
- Keywords
- Keratoconus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Glaukos CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Dec 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Feb 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.
Multi-center, parallel-group, placebo-controlled trial designed to assess the safety and efficacy of twice-daily topically administered GLK-221 Ophthalmic Solution in subjects with keratoconus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLK-221 Ophthalmic Solution | Experimental | Drug: GLK-221 Ophthalmic SolutionGLK-221 Ophthalmic Solution administered topically twice daily to both eyes |
| Placebo | Placebo comparator | Drug: Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution administered topically twice daily to both eyes |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Be ≥ 18 and ≤ 55 years of age
- Diagnosis of keratoconus in the study eye
Key exclusion criteria (2 listed)
- Pregnant, lactating or planning a pregnancy
- Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial
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 |
|---|---|---|
| GLK-221 Ophthalmic SolutionGLK-221 Ophthalmic Solution administered twice daily to both eyes | Drug | GLK-221 Ophthalmic Solution |
| Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution administered twice daily to both eyes | Drug | Placebo |
Primary outcome
Mean change from baseline in maximum corneal curvature
Time frame: 16 weeks
Mean change from baseline in maximum corneal curvature
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 10 Feb 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, MD 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 2 study testing GLK-221 Ophthalmic Solution 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 2 inclusion and 2 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 10 Feb 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. 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 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.
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 Manager (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?
Mean change from baseline in maximum corneal curvature (time frame: 16 weeks). 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 10 Feb 2026; AzTrials last refreshed its copy on 5 Nov 2026.