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

NCT03049852 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CBT-CS101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Pterygium Vascularity Change Assessed Using the Pterygium Hyperemia Grading Scale

  The primary efficacy variable is the change from baseline (Day 1) in severity grade of pterygium vascularity at Week 4. Pterygium vascularity intensity is based on color coordinates as measured by digital image analysis of pterygium photographs. The quantitative analysis of photographs using a 5-point Pterygium Hyperemia Grading Scale (0 = absent, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) will be conducted at an independent image reading center.

  Change from baseline at 4 weeks

• Ocular and General Safety and Tolerability

  The ocular safety and tolerability are measured by biomicroscopy, ophthalmoscopy, intraocular pressure and visual acuity, and to assess general safety by physical exams, vital signs, clinical laboratory tests and adverse events reporting

  One day

Secondary Outcomes (1)

• Corneal Pterygium Lesion Length Change From Baseline

  4 weeks

Study Arms (3)

CBT-001 Ophthalmic Solution Single dose

EXPERIMENTAL

One drop in the study administered one time only for one day

Drug: CBT-001 single dose

Vehicle

PLACEBO COMPARATOR

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

Drug: Vehicle

CBT-001 Ophthalmic Solution Multidose

EXPERIMENTAL

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

Drug: CBT-001 Multi-dose

Interventions

CBT-001 single dose DRUG

One drop in the study administered one time

CBT-001 Ophthalmic Solution Single dose

Vehicle DRUG

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

Vehicle

CBT-001 Multi-dose DRUG

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

CBT-001 Ophthalmic Solution Multidose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary pterygium with moderate vascularity (Pterygium Hyperemia Grading Scale ≥ 3)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cloudbreak Therapeutics, LLC: lead

Study Sites (1)

Harvard Eye Associates

Laguna Beach, California, 92651, United States

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases

Results Point of Contact

• Title: Dr, Jinsong Ni
• Organization: Cloudbreak Therapeutics, LLC

Ni-Jinsong@cloudbreaktherapeutics.com

9496789752

Study Officials

• John Hovanesian, M.D.

  Harvard Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 10, 2017
• Study Start: April 15, 2017
• Primary Completion: April 30, 2018
• Study Completion: April 30, 2018
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)