Placebo-controlled Study to Evaluate the Safety and Effic... | NCT07400952

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

NCT07400952

Sponsor

Glaukos Corporation

Status

Recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

100Estimated

Phase

Phase 2

Conditions

Keratoconus

Interventions

GLK-221 Ophthalmic Solution
Placebo Ophthalmic Solution

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2025Actual

Primary Completion Date

Apr 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Feb 3, 2026

First Submission Date that Met QC Criteria

Feb 3, 2026

First Posted Date

Feb 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
GLK-221 Ophthalmic Solution	Drug	GLK-221 Ophthalmic Solution administered twice daily to both eyes	GLK-221 Ophthalmic Solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean change from baseline in maximum corneal curvature	Mean change from baseline in maximum corneal curvature	16 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Study Manager	Contact	949-739-8749		ClinicalResearch@Glaukos.com

Overall Officials

Name	Affiliation	Role
Study Director, MD	Glaukos Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaukos Clinical Study Site	Recruiting	Westerville	Ohio	43082	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007640	Keratoconus

Ancestor Terms

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided