Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium

• Status: Completed
• Trial end date: 2018-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24)

Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup (n=51)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cloudbreak Therapeutics, LLC
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

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