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:

  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

Detailed Summary:
Sponsor: Cloudbreak Therapeutics, LLC

Current Primary Outcome: Pterygium Vascularity assessed using the Pterygium Hyperemia Grading Scale [ Time Frame: 6 months ]

Pterygium vascularity will be graded by analysis of digital images of the eyes using Pterygium Hyperemia Grading Scale


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