Clinical trial NCT05456425: A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium
Official title: Multicenter, Double-Masked, Randomized, Vehicle-Controlled 12-Month Parallel Comparison of the Safety and Efficacy of 0.1% and 0.2% CBT-001 Versus Vehicle, Dosed Twice-Daily, in Patients With Pterygium
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pterygium
Lead sponsor: Cloudbreak Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2022-07-13
Enrollment: 600
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, Double-Masked, Randomized, Vehicle-Controlled Parallel Comparison with dosing twice-daily in eye(s) with pterygium
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.

Detailed description: Clinical Hypotheses:

1. CBT-001 dosed twice daily is more effective than vehicle in:

   * Reducing conjunctival hyperemia by demonstrating a statistically significant difference and clinically relevant improvement in the mean severity grade change from baseline.
   * Preventing pterygium progression, by demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline.
2. CBT-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.

Eligibility criteria: Inclusion Criteria:

Pterygium with conjunctival hyperemia

Exclusion Criteria:

Pterygium removal within the last 6 months

Primary outcomes:
measure: conjunctival hyperemia
timeFrame: 3 month
measure: pterygium length
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Sun City
country: United States
facility: Walman Eye Center
state: Arizona
city: Bakersfield
country: United States
facility: Bakersfield Eye Institute
state: California
city: Bakersfield
country: United States
facility: West Coast Eye Institute
state: California
city: Glendale
country: United States
facility: Global Research Mangement
state: California
city: Hemet
country: United States
facility: Inland Eye Specialists
state: California
city: Northridge
country: United States
facility: Shultz Chang Vision
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Eye Care
state: California
city: Delray Beach
country: United States
facility: Bruce A. Segal, MD
state: Florida
city: Tampa
country: United States
facility: International Research Center
state: Florida
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Springfield
country: United States
facility: Mercy Clinic Eye Specialists
state: Missouri
city: Henderson
country: United States
facility: Center for Sight
state: Nevada
city: Las Vegas
country: United States
facility: Wellish Vision Institute
state: Nevada
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: McAllen
country: United States
facility: DCT-Shah Research, LLC dba Discovery Clinical Trials
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research, LLC
state: Texas
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute, LLC
state: Virginia
city: Norfolk
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: East Melbourne
country: Australia
facility: The Centre for Eye Research Australia
state: Melbourne
city: Albury
country: Australia
facility: Eyeclinic Albury Wodonga
state: New South Wales
city: St Albans
country: Australia
facility: Sunshine Eye Surgeons
state: Victoria
city: Beijing
country: China
facility: Beijing Tongren Hospital; CMU
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Haikou
country: China
facility: Hainan Provincial Eye Hospital
city: Hengyang
country: China
facility: 1st Affiliated Hospital of University of South China
city: Kunming
country: China
facility: The Second People's Hospital of Yunnan Province
city: Nanchang
country: China
facility: The First Affiliated Hospital of NC University
city: Qingdao
country: China
facility: Eye Hospital of Shandong First Medical University
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical University
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College
city: Xiamen
country: China
facility: Xiamen Eye Center of Xiamen University
city: Ahmedabad
country: India
facility: Netralaya Super Specialty Eye Hospital
state: Gujarat
city: Ahmedabad
country: India
facility: M and J Western
state: Gujarat
city: Bangalore
country: India
facility: Narayana Nethralaya
state: Karnataka
city: Nashik
country: India
facility: Chopda Medicare
state: Maharashtra
city: Bhubaneswar
country: India
facility: L V Prasad Eye Institute
state: Odisha
city: Bīkaner
country: India
facility: SP Medical College and AG of Hospitals
state: Rajasthan
city: Noida
country: India
facility: Icare Eye Hospital
state: Uttar Pradesh
city: Chandigarh
country: India
facility: Advanced Eye Centre PGIMER
city: Auckland
country: New Zealand
facility: Auckland Eye
city: Auckland
country: New Zealand
facility: Eye Institute
city: Christchurch
country: New Zealand
facility: Southern Eye Specialists
Study officials:
References: