ClinicalTrials.gg
RecruitingNCT07400952Updated Feb 10, 2026

Placebo-controlled Study to Evaluate the Safety and Efficacy of GLK-221 Ophthalmic Solution in Subjects With Keratoconus

A Phase 2 interventional study of GLK-221 Ophthalmic Solution and Placebo Ophthalmic Solution in Keratoconus, sponsored by Glaukos Corporation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by Glaukos Corporation · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Keratoconus

Browse trials for

Keywords

  • Keratoconus
03

In context

Keratoconus

313 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's planned enrollment of 100 is above the median of 40 across 205 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Glaukos Corporation is the lead sponsor of 67 studies on the registry; 14 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be ≥ 18 and ≤ 55 years of age
  • Diagnosis of keratoconus in the study eye

Exclusion criteria

Exclusion Criteria:

  • Pregnant, lactating or planning a pregnancy
  • Currently enrolled, or within 30 days prior to Screening were enrolled, in another drug or device trial
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    GLK-221 Ophthalmic Solution

    GLK-221 Ophthalmic Solution administered topically twice daily to both eyes

    Drug: GLK-221 Ophthalmic Solution

  • Placebo comparator
    Placebo

    Placebo Ophthalmic Solution administered topically twice daily to both eyes

    Drug: Placebo Ophthalmic Solution

Interventions

  • DrugGLK-221 Ophthalmic Solution

    GLK-221 Ophthalmic Solution administered twice daily to both eyes

  • DrugPlacebo Ophthalmic Solution

    Placebo Ophthalmic Solution administered twice daily to both eyes

06

What researchers measure

Primary outcomes

  1. Mean change from baseline in maximum corneal curvature

    Mean change from baseline in maximum corneal curvature

    Time frame: 16 weeks

07

Study locations

1 of 1 sites recruiting
  • Glaukos Clinical Study Site
    Westerville, Ohio 43082, United States
    Recruiting
    • Study Manager · Contact949-739-8749
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07400952
Responsible party
Sponsor
First posted
Feb 10, 2026
Start date
Dec 23, 2025
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Feb 10, 2026

Study contacts

Study Manager
Contact
ClinicalResearch@Glaukos.com
949-739-8749
Study Director, MD
study director · Glaukos Corporation

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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