Phase 2
Completed N=75
Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium
Source: ClinicalTrials.gov NCT03049852 ↗Enrolled (actual)
75
Serious AEs
1.3%
Results posted
Feb 2020
Primary outcomePrimary: Pterygium Vascularity Change Assessed Using the Pterygium Hyperemia Grading Scale — 0; -0.8 grade — p=<0.001
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pterygium Vascularity Change Assessed Using the Pterygium Hyperemia Grading Scale |
0; -0.8 | <0.001 sig |
| PRIMARY Ocular and General Safety and Tolerability |
3; 1 | — |
| SECONDARY Corneal Pterygium Lesion Length Change From Baseline |
-0.11; 0.16 | 0.007 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03049852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.