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Experimental: 2.5% CBT-008 for Meibomian Gland Dysfunction

Phase 2
Waitlist Available
Research Sponsored by Cloudbreak Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month
Awards & highlights

Study 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

Eligible Conditions
  • Meibomian Gland Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment-emergent adverse event
Secondary outcome measures
Ocular discomfort score (0-4)

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: 2.5% CBT-008Experimental Treatment1 Intervention
2.5% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.
Group II: Experimental: 10% CBT-008Experimental Treatment1 Intervention
10% CBT-008 ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.
Group III: Placebo Comparator: CBT-008Placebo Group1 Intervention
CBT-008 vehicle ophthalmic solution contains sodium phosphate monobasic monohydrate, sodium chloride, purified water, and sodium hydroxide to adjust pH to 7.4.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CBT-008
2022
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Cloudbreak Therapeutics, LLCLead Sponsor
5 Previous Clinical Trials
924 Total Patients Enrolled
1 Trials studying Meibomian Gland Dysfunction
90 Patients Enrolled for Meibomian Gland Dysfunction
Bing Leng, MDStudy DirectorADS Therapeutics, LLC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction
2022. "Safety, Efficacy and Pharmacokinetics of CBT-008 in Patients With Meibomian Gland Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05261386.
~30 spots leftby Apr 2025
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