Clinical Trial: Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: 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
Brief Summary:
- CBT-001 administered three times daily (TID) for 4 weeks has an acceptable safety profile when used in pterygium patients
- CBT-001 administered TID for 4 weeks is more effective than the vehicle in reducing pterygium vascularity and inhibiting pterygium lesion growth
- CBT-001 administered as topical ocular dosing displays negligible systemic drug exposure
Detailed Summary:
Sponsor: Cloudbreak Therapeutics, LLC
Current Primary Outcome: Pterygium Vascularity assessed using the Pterygium Hyperemia Grading Scale [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Cloudbreak Therapeutics, LLC
Dates:
Date Received: February 3, 2017
Date Started: April 15, 2017
Date Completion: February 1, 2018
Last Updated: February 9, 2017
Last Verified: February 2017