Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus

Phase 4RecruitingNCT07629557

Glaukos Corporation15 enrolled

Overview

Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Keratoconus

Interventions

Riboflavin Ophthalmic SolutionsDRUG

Riboflavin Ophthalmic Solutions

UV-A Irradiation SystemDEVICE

O2n UV-A Irradiation System

Eligibility

Sex: ALLMin age: 13 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provide written informed consent * Willing and able to comply with study instructions and follow-up visits * Diagnosis of keratoconus in each eye Exclusion Criteria: * 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

Locations (1)

Glaukos Investigative Site

Westerville, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Approximately 2.5 Months

Central Contacts

Study Director

CONTACT

949-739-8749 ClinicalResearch@glaukos.com

Data from ClinicalTrials.gov

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