NCT04884243

Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction

A Phase 2 Multicenter, Double-masked, Randomized, Vehicle-controlled, Parallel Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CBT-006 in Patients With Meibomian Gland Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Cloudbreak Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

STUDY DESIGN Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study. Duration: 3 months of TID treatment. Treatment Groups, Dosing, and Treatment Regimen: Study Treatment: CBT-006 topical ophthalmic solution Control Treatment: CBT-006 vehicle

Detailed description

Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study. Duration: 3 months of TID treatment. Treatment Groups, Dosing, and Treatment Regimen: Study Treatment: CBT-006 topical ophthalmic solution Control Treatment: CBT-006 vehicle

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DRUG	CBT-006	ophthalmic solution

Timeline

• Start date: 2021-09-05
• Primary completion: 2023-08-17
• Completion: 2023-08-17
• First posted: 2021-05-12
• Last updated: 2024-04-24
• Results posted: 2024-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study