CompletedPhase 2

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

United States75 participantsStarted 2017-04-15

Plain-language 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)

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Pterygium Vascularity Change Assessed Using the Pterygium Hyperemia Grading Scale

Timeframe: Change from baseline at 4 weeks

Ocular and General Safety and Tolerability

Timeframe: One day

Trial details

NCT IDNCT03049852

SponsorCloudbreak Therapeutics, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-04-30

Results submitted2020-01-28

View on ClinicalTrials.gov More Pterygium trials