Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/7/2018 |
| Start Date: | April 15, 2017 |
| End Date: | April 30, 2018 |
A Phase 2a Multicenter, Randomized, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CBT-001 Ophthalmic Solution in Patients With Primary or Recurrent Pterygium
1. CBT-001 administered three times daily (TID) for 4 weeks has an acceptable safety
profile when used in pterygium patients
2. CBT-001 administered TID for 4 weeks is more effective than the vehicle in reducing
pterygium vascularity and inhibiting pterygium lesion growth
3. CBT-001 administered as topical ocular dosing displays negligible systemic drug exposure
profile when used in pterygium patients
2. CBT-001 administered TID for 4 weeks is more effective than the vehicle in reducing
pterygium vascularity and inhibiting pterygium lesion growth
3. CBT-001 administered as topical ocular dosing displays negligible systemic drug exposure
Inclusion Criteria:
- Primary pterygium with moderate vascularity (Pterygium Hyperemia Grading Scale ≥ 3)
Exclusion Criteria:
- Active ocular disease, corneal abnormalities other than pterygium, active ocular
infection, or any ocular pathology unrelated to pterygium in either eye that could
affect the assessment of the pterygium
- History of ocular herpes disease in either eye
- Any ocular surgical procedure within the last 3 months
- Female patients who are pregnant, nursing, or planning a pregnancy during the study
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