NCT07400952

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
10mo left

Started Dec 2025

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Dec 2025Apr 2027

Study Start

First participant enrolled

December 23, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Keratoconus

Keywords

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in maximum corneal curvature

    Mean change from baseline in maximum corneal curvature

    16 weeks

Study Arms (2)

GLK-221 Ophthalmic Solution

EXPERIMENTAL

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

Drug: GLK-221 Ophthalmic Solution

Placebo

PLACEBO COMPARATOR

Placebo Ophthalmic Solution administered topically twice daily to both eyes

Drug: Placebo Ophthalmic Solution

Interventions

GLK-221 Ophthalmic SolutionDRUG

GLK-221 Ophthalmic Solution administered twice daily to both eyes

GLK-221 Ophthalmic Solution
Placebo Ophthalmic SolutionDRUG

Placebo Ophthalmic Solution administered twice daily to both eyes

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnant, lactating or planning a pregnancy
  • Currently enrolled, or within 30 days prior to Screening were enrolled, in another investigational drug or device trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaukos Clinical Study Site

Westerville, Ohio, 43082, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Study Director, MD

    Glaukos Corporation

    STUDY DIRECTOR

Central Study Contacts

Study Manager

CONTACT

949-739-8749ClinicalResearch@Glaukos.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

December 23, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)