Evaluating CBT-001 eye drops for treating pterygium
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
This study is testing if CBT-001 eye drops can safely help people with pterygium by reducing redness and slowing down the growth of the condition over two years.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Cloudbreak Therapeutics, LLC Industry-sponsored |
| Locations | 44 sites (Phoenix, Arizona and 43 other locations) |
| Trial ID | NCT05456425 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and efficacy of CBT-001 eye drops administered twice daily for 24 months in patients with pterygium. Participants will receive either low or high doses of CBT-001 or a placebo vehicle to compare the effects on conjunctival hyperemia and pterygium progression. The study will measure changes in the severity of conjunctival hyperemia and the length of pterygium from baseline to determine the effectiveness of the treatment. Additionally, the trial will monitor the safety and tolerability of CBT-001 over the treatment period.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with pterygium accompanied by conjunctival hyperemia.
Not a fit: Patients who have undergone pterygium removal within the last 6 months will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of pterygium and enhance patients' quality of life.
How similar studies have performed: Other studies have explored treatments for pterygium, but the specific approach with CBT-001 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Pterygium with conjunctival hyperemia Exclusion Criteria: Pterygium removal within the last 6 months
Where this trial is running
Phoenix, Arizona and 43 other locations
- Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States (Recruiting)
- Walman Eye Center — Sun City, Arizona, United States (Recruiting)
- Bakersfield Eye Institute — Bakersfield, California, United States (Recruiting)
- West Coast Eye Institute — Bakersfield, California, United States (Recruiting)
- Global Research Mangement — Glendale, California, United States (Recruiting)
- Inland Eye Specialists — Hemet, California, United States (Recruiting)
- Shultz Chang Vision — Northridge, California, United States (Recruiting)
- Santa Barbara Eye Care — Santa Barbara, California, United States (Recruiting)
- Bruce A. Segal, MD — Delray Beach, Florida, United States (Recruiting)
- International Research Center — Tampa, Florida, United States (Recruiting)
- The Eye Care Institute — Louisville, Kentucky, United States (Recruiting)
- Mercy Clinic Eye Specialists — Springfield, Missouri, United States (Recruiting)
- Center for Sight — Henderson, Nevada, United States (Recruiting)
- Wellish Vision Institute — Las Vegas, Nevada, United States (Recruiting)
- Vance Thompson Vision — Sioux Falls, South Dakota, United States (Recruiting)
- Baylor College of Medicine — Houston, Texas, United States (Recruiting)
- DCT-Shah Research, LLC dba Discovery Clinical Trials — McAllen, Texas, United States (Recruiting)
- R and R Eye Research, LLC — San Antonio, Texas, United States (Recruiting)
- Emerson Clinical Research Institute, LLC — Falls Church, Virginia, United States (Recruiting)
- Wagner Macula & Retina Center — Norfolk, Virginia, United States (Recruiting)
- The Centre for Eye Research Australia — East Melbourne, Melbourne, Australia (Recruiting)
- Eyeclinic Albury Wodonga — Albury, New South Wales, Australia (Recruiting)
- Sunshine Eye Surgeons — St Albans, Victoria, Australia (Recruiting)
- Beijing Tongren Hospital; CMU — Beijing, China (Recruiting)
- West China Hospital of Sichuan University — Chengdu, China (Recruiting)
- Hainan Provincial Eye Hospital — Haikou, China (Recruiting)
- 1st Affiliated Hospital of University of South China — Hengyang, China (Recruiting)
- The Second People's Hospital of Yunnan Province — Kunming, China (Recruiting)
- The First Affiliated Hospital of NC University — Nanchang, China (Recruiting)
- Eye Hospital of Shandong First Medical University — Qingdao, China (Recruiting)
- Eye Hospital of Wenzhou Medical University — Wenzhou, China (Recruiting)
- Union Hospital Tongji Medical College — Wuhan, China (Recruiting)
- Xiamen Eye Center of Xiamen University — Xiamen, China (Recruiting)
- Netralaya Super Specialty Eye Hospital — Ahmedabad, Gujarat, India (Recruiting)
- M and J Western — Ahmedabad, Gujarat, India (Recruiting)
- Narayana Nethralaya — Bangalore, Karnataka, India (Recruiting)
- Chopda Medicare — Nashik, Maharashtra, India (Recruiting)
- L V Prasad Eye Institute — Bhubaneswar, Odisha, India (Recruiting)
- SP Medical College and AG of Hospitals — Bīkaner, Rajasthan, India (Recruiting)
- Icare Eye Hospital — Noida, Uttar Pradesh, India (Recruiting)
- Advanced Eye Centre PGIMER — Chandigarh, India (Recruiting)
- Auckland Eye — Auckland, New Zealand (Recruiting)
- Eye Institute — Auckland, New Zealand (Recruiting)
- Southern Eye Specialists — Christchurch, New Zealand (Recruiting)
Study contacts
- Study coordinator: Abu Abraham, MD
- Email: CBT-CS301Study@cloudbreakpharma.com
- Phone: 949-234-7147
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.