At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 75 enrolled
Drug / intervention
CBT-001 single dose +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating CBT-001 single dose, Vehicle, and 1 other intervention for Pterygium. Completed, enrolled 75 participants across 1 site.
Detailed 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)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPterygium
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 2017
Enrollment StartApr 2017
Primary CompletionApr 2018
TodayJul 2026
First PostedFeb 10, 2017
Enrollment StartApr 15, 2017
Primary CompletionApr 30, 2018
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.4 years ago
Interventions
CBT-001 single dosedrug
One drop in the study administered one time
Vehicledrug
One drop in the study administered three times daily (TID) for 4 weeks
CBT-001 Multi-dosedrug
One drop in the study administered three times daily (TID) for 4 weeks