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Also known as riboflavin ophthalmic solution, riboflavin solution
riboflavin · 4 trials · 3 indications
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
| Arm | Type | Description |
|---|---|---|
| riboflavin solution and KXL System | EXPERIMENTAL | Subjects will receive riboflavin solution followed by UVA irradiation for 4 minutes |
| placebo solution and KXL System | PLACEBO_COMPARATOR | Subjects will receive placebo solution followed by UVA irradiation for 4 minutes |
| Corneal Collagen Cross-linking (CXL) Treatment Group | ACTIVE_COMPARATOR | riboflavin ophthalmic solution and UVA irradiation |
| Control Group | SHAM_COMPARATOR | riboflavin ophthalmic solution without UVA irradiation. |
| Name | Type | Description |
|---|---|---|
| riboflavin solution | DRUG | 0.12% riboflavin ophthalmic solution |
| placebo solution | DRUG | 0.0% riboflavin ophthalmic solution |
| KXL System | DEVICE | 30 mW/cm2 |
| riboflavin ophthalmic solution | DRUG | riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL) |
| UVA Irradiation | DEVICE | UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes |
Inclusion Criteria: Patients must meet all of the following criteria in order to be enrolled into the trial: 1. Be at least 12 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form. Patients who are under the age of 18 will need to sign an assent form...
Riboflavin ophthalmic solution is used in corneal collagen cross-linking procedures to treat keratoconus, progressive keratoconus, and corneal ectasia. It is applied to the cornea as part of a cross-linking treatment designed to strengthen corneal tissue in these conditions. Glaukos Corporation is developing it as a small molecule therapy in ophthalmology.
Glaukos Corporation, which trades under the ticker GKOS, is the developer of riboflavin ophthalmic solution. The company is advancing the asset for corneal conditions including keratoconus and ectasia.
Riboflavin ophthalmic solution is in Phase 3 clinical development. It is an investigational therapy and is not approved. Four Phase 3 trials have been completed, and no trials are currently active.
Riboflavin ophthalmic solution has been studied in completed Phase 3 trials including NCT01643226 and NCT01344187 in keratoconus, NCT00674661 in ectasia, and NCT00647699 in progressive keratoconus. These trials enrolled a combined 466 participants across United States sites, with participants aged 12 years and older.
Yes. Riboflavin ophthalmic solution and riboflavin solution are alternative names for riboflavin as developed by Glaukos Corporation. Searches for any of these names refer to the same investigational ophthalmology asset being studied in corneal cross-linking for keratoconus and ectasia.