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A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental | Epithelium-on corneal cross-linking |
|
| Control Treatment | Placebo Comparator | Placebo and sham for epithelium-on corneal cross-linking |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin and Sodium Iodide solution and Ultraviolet-A treatment | Combination Product | Drug: Ribostat riboflavin and sodium iodide ophthalmic solution Device: UV-3000 ultraviolet A light source |
| Measure | Description | Time Frame |
|---|---|---|
| Best Spectacle-Corrected Distance Visual Acuity (BSCDVA) | BSCDVA will be assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. The score ranges from 0 to 100, with a higher score representing better visual functioning. | Baseline to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Vision-related Quality of Life as Assessed by the National Eye Institute 25-Item Visual Function Questionnaire (NEI-VFQ-25) | The score on the NEI-VFQ-25 ranges from 0 to 100, with a higher score indicating greater functioning. | Baseline to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Belin, MD | Epion Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwartz Laser Eye Center | Scottsdale | Arizona | 85260 | United States | ||
| Catalina Eye Center |
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| Placebo and sham treatment | Combination Product | Drug: placebo ophthalmic solution Device: UV-3000 light source |
|
| Tucson |
| Arizona |
| 85712 |
| United States |
| Inland Eye Specialists | Murrieta | California | 92562 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| Chicago Cornea Consultants | Highland Park | Illinois | 60035 | United States |
| Claris Vision LLC Eye Health Vision Centers - Dartmouth | North Dartmouth | Massachusetts | 02747 | United States |
| Truhlsen Eye Institute | Omaha | Nebraska | 68105 | United States |
| Providence Eye and Laser Specialists | Charlotte | North Carolina | 28226 | United States |
| VRF Eye Specialty Group | Memphis | Tennessee | 38120 | United States |
| Dell Laser Consultants | Austin | Texas | 78746 | United States |
| Hoopes Vision | Draper | Utah | 84020 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
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