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

NCT03049852 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2020-02-24

Study results available
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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)

Conditions

  • Pterygium

Interventions

DRUG

CBT-001 single dose

One drop in the study administered one time

DRUG

Vehicle

One drop in the study administered three times daily (TID) for 4 weeks

DRUG

CBT-001 Multi-dose

One drop in the study administered three times daily (TID) for 4 weeks

Sponsors & Collaborators

  • Cloudbreak Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • John Hovanesian, M.D. · Harvard Eye Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2018-04-30
Completion
2018-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03049852 on ClinicalTrials.gov