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Immunosuppressant

cyclosporine 0.1% / loteprednol 0.2% group for Dry Eye Syndrome (CLEAN Trial)

Phase 3

Waitlist Available

Led By John Hovanesian, MD

Research Sponsored by Research Insight 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 up to 2 months

Awards & highlights

CLEAN Trial Summary

This trial found that using a combination of cyclosporine and loteprednol was more effective at treating dry eye than using cyclosporine alone.

Eligible Conditions

Dry Eye Syndrome

CLEAN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Study Measure - Corneal Higher Order Aberrations by Topography

Secondary outcome measures

Secondary Measure - SPEED Questionnaire to track progression of dry eye symptoms over time

Other outcome measures

Exploratory Outcome Measure

CLEAN Trial Design

2Treatment groups

Active Control

Group I: cyclosporine 0.1% / loteprednol 0.2% groupActive Control1 Intervention

60 total patients will be randomized in a 2 to 1 proportion with 40 in the cyclosporine 0.1% / loteprednol 0.2% group and 20 in the cyclosporine 0.05% group. All patients will undergo treatment in both eyes.

Group II: cyclosporine 0.05% groupActive Control1 Intervention

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Who is running the clinical trial?

Research Insight LLCLead Sponsor

10 Previous Clinical Trials

724 Total Patients Enrolled

John Hovanesian, MDPrincipal InvestigatorHarvard Eye Associates

11 Previous Clinical Trials

4,364 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people can join this research project?

"Yes, the trial is still open for enrolment according to the most recent update on clinicaltrials.gov. The study was originally posted on 6/3/2022 and was last edited on 6/21/2022. They are looking for 60 participants between 3 locations."

Answered by AI

How severe are the side effects of cyclosporine 0.05% group?

"There is some evidence, from Phase 3 trials, of efficacy and multiple rounds of data supporting safety, so our team at Power have given cyclosporine 0.05% a score of 3 for safety."

Answered by AI

Are there any vacancies in this study for new participants?

"That is correct, the clinicaltrials.gov website has information indicating that this study is looking for new patients right now. The posting date was June 3rd, 2022 and the most recent update was on June 21st, 2022. They are hoping to have 60 people sign up and participate across three different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization

2022. "Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05322148.