Evaluate the Safety and Feasibility of Same-Day Bilateral Epithelium-On Corneal Cross-Linking for Keratoconus
ConditionKeratoconus
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age13+
SponsorGlaukos Corporation
About this trial
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide written informed consent
Willing and able to comply with study instructions and follow-up visits
Diagnosis of keratoconus in each eye
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Riboflavin Ophthalmic Solutions
DrugRiboflavin Ophthalmic Solutions
UV-A Irradiation System
DeviceO2n UV-A Irradiation System
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Epioxa™ HD/Epioxa™ and UV-A IrradiationExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov