Keratoconus
Conditions
Keywords
Keratoconus, Corneal Cross-linking
Brief summary
Clinical trial to evaluate the safety and feasibility of corneal cross-linking in both eyes on the same day in subjects with keratoconus.
Interventions
DRUGRiboflavin Ophthalmic Solutions
Riboflavin Ophthalmic Solutions
DEVICEUV-A Irradiation System
O2n UV-A Irradiation System
Sponsors
Glaukos Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful completion of bilateral epithelium-on corneal collagen cross-linking. | Approximately 2.5 Months | Portion of subjects that the Investigator completed bilateral epithelium-on corneal collagen cross-linking treatment on the same day. |
Countries
United States
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
Glaukos Corporation
Outcome results
None listed