NCT05261386

Safety, Efficacy and Pharmacokinetics of CBT-008 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-008 in Patients With Meibomian Gland Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: Cloudbreak Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Study Design Structure: Multicenter, randomized, double-masked, vehicle-controlled, parallel group study Duration: 1 month of TID treatment Treatment Groups, Dosing, and Treatment Regimen Study Treatment: CBT-008 topical ophthalmic solution Control Treatment: CBT-008 vehicle

Detailed description

Structure Multicenter, randomized, double-masked, vehicle-controlled, parallel group study. Duration Stage 1: 1 month Stage 2: 1 day (1 dose) Treatment Groups, Dosing, and Treatment Regimen 1. Study Treatment Stage 1: CBT-008 ophthalmic solution was administered as 1 drop OU TID Stage 2: CBT-008 ophthalmic solution was administered as 1 drop in the study eye 2. Control Treatment CBT-008 vehicle 3. Methods for Masking Study medication will be packaged in identical kits and will be labeled with medication kit numbers. The central randomization system will provide the site with a specific medication kit number for the patient corresponding to the treatment group assigned. 4. Instructions for Storage, Use, and Administration Study medication will be supplied as preservative free-unit dose containers, where 1 mL of CBT-008 ophthalmic solution will be aseptically filled into 3 mL Low Density Polyethylene (LDPE) ophthalmic dropper bottles. Study medication should be stored at room temperature in a secure area at clinical sites and dispensed only to patients enrolled into the clinical study. Patients will be instructed to store study medication in a cool place at room temperature at home. Study medication will be administered TID, one drop, to both eyes. First instillation of study medication on the first day will be applied by subject or care provider with site staff's observation for training and supervision. During the rest of the study treatment, patients will self-administer the medication TID for 1 month.

Conditions

• Meibomian Gland Dysfunction

Interventions

Type	Name	Description
DRUG	CBT-008	Treat MGD

Timeline

• Start date: 2022-03-04
• Primary completion: 2022-09-07
• Completion: 2023-03-29
• First posted: 2022-03-02
• Last updated: 2024-04-24
• Results posted: 2024-04-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study