Clinical Trials Logo
  1. Home
  2. Pterygium
  3. NCT05456425

A Clinical Trial on Safety and Efficacy of CBT-001 in Patients With Pterygium

Pterygium Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05456425
Study type Interventional
Source Cloudbreak Therapeutics, LLC
Contact Abu Abraham, MD
Phone 949-234-7147
Email CBT-CS301Study@cloudbreakpharma.com
Status Recruiting
Phase Phase 3
Start date June 30, 2022
Completion date December 31, 2026
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT02641132 - Pterygium Head Body MMC1: Two Different Surgical Procedures and Their Effect on Endothelial Cell Count. Phase 4
Completed NCT02342392 - Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study Phase 2/Phase 3
Recruiting NCT01387971 - Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders N/A
Recruiting NCT05978687 - The Use of Lidocaine Gel Versus Subconjunctival Xylocaine Injection in Pterygium Excision Phase 4
Not yet recruiting NCT06042296 - Expression of CD44, PCNA and E-cadherin in Pterygium Tissue
Completed NCT04022811 - Effect of Bromfenac on Pain Related to Pterygium Surgery Phase 4
Recruiting NCT01249235 - Bandage Contact Lens and Oral Analgesics Versus Patching and Oral Analgesics for Pain Following Pterygium Surgery N/A
Recruiting NCT01261455 - Prospective Randomized Pilot Study Comparing Inferior Versus Superior Conjunctival Autografts for Primary Pterygia N/A
Completed NCT01115517 - Safety Study of Avastin Used as Adjunctive Therapy in Pterygium Surgery Phase 2
Completed NCT00768963 - Ranibizumab for the Inhibition of Neovascularization in Pterygia Phase 1
Completed NCT00949728 - Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia N/A
Recruiting NCT00563277 - Surgical Treatment of Concurrent Cataract and Primary Pterygium N/A
Completed NCT00346450 - Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface Transplantation Phase 3
Completed NCT03533244 - A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia Phase 2
Completed NCT04403516 - Dextenza in Pterygium Surgery Phase 4
Recruiting NCT02911532 - Tissue Engineering Conjunctiva for the Treatment of Pterygium and Atretoblepharia N/A
Not yet recruiting NCT03304366 - Corneal Changes With Pentacam Before and After Pterygium N/A
Unknown status NCT02015000 - Surgical Result of Pterygium Extended Removal Followed by Fibrin Glue Assisted Amniotic Membrane Transplantation N/A
Completed NCT00344201 - Assessment of Fibrin Glue in Pterygium Surgery and Other Forms of External Eye Surgery Phase 1
Recruiting NCT00326560 - Comparison of Glue With Sutures for Pterygium Surgery Phase 3