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

Dry Eye Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

Thirty million people in the US are thought to suffer from dry eye. Patients with this condition manifest with ocular surface disruption such as corneal fluorescein staining and reduced tear breakup time (TBUT). Successful treatment is a high priority for both patients and physicians, reducing symptoms and improving visual acuity and corneal higher order aberrations (HOAs), which have been closely linked with treatment satisfaction. 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. This study is designed to demonstrate that Klarity CL can benefit the ocular surface with high tolerability, making it a very desirable method of treating patients with dry eye. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05322148
Study type Interventional
Source Research Insight LLC
Contact
Status Completed
Phase Phase 3
Start date June 3, 2022
Completion date November 21, 2022
View Details
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