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

NCT05322148 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2023-01-04

No results posted yet for this study

Summary

The CLEAN Study: Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization-A Prospective Cohort Study of Combination Therapy in the Treatment of Dry Eye

Conditions

  • Dry Eye

Interventions

DRUG

Klarity CL, Cylcosporine 0.1%/Loteprednol Etabonate 0.2% Preservative Free

A number of studies have shown the benefit of both cyclosporine and steroids in managing dry eye. However, existing formulations of these products are challenged by either limited tolerability, a high out-of-pocket cost or both. Combination therapy with these agents in an advanced, more tolerable formulation have the potential to improve both tolerability and cost. However, the available formulation of preservative free Klarity CL (cyclosporine 0.1% and loteprednol 0.2% in a chondroitin sulfate vehicle) has not been studied rigorously.

Sponsors & Collaborators

  • Research Insight LLC

    lead INDUSTRY

Principal Investigators

  • John Hovanesian, MD · Harvard Eye Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2022-11-17
Completion
2022-11-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05322148 on ClinicalTrials.gov