NCT02199964

The Effects of Cyclosporin A in a Low Humidity Environment, on the Ocular Surface

The Effects of Cyclosporin A Emulsion, (Restasis), on the Ocular Surface in Response to Low Humidity Environment in Patients With Dry Eye

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test that hypothesis that topical administration of the FDA approved immunomodulatory agent cyclosporin A emulsion will minimize irritation and ocular surface disease that results from a short term low humidity environmental stress

Detailed description

This is a pilot study designed to evaluate the effect of two conventional dry eye therapies, artificial tears to hydrate and cyclosporine A as an anti-inflammatory, on the irritation symptoms and ocular surface disease of dry eye patients who will be exposed to a low humidity environment for 90 minutes. Patients with dry eye will be enrolled in this study and complete a validated symptom questionnaire and then undergo a complete ocular surface and tear examination to characterize their disease. Enrolled subjects will be exposed to a low humidity environment at the initial evaluation prior to any treatment and will be exposed to a low humidity environment for a second time. They will be randomized to receive either artificial tears or 0.05% cyclosporine A emulsion drop four times a day for 6 weeks.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Cyclosporin 0.05% emulsion	Topical therapy for dry eye
DRUG	Endura, Refresh artificial tears	Over the counter therapy for dry eye, used 4 times a day

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2014-07-25
• Last updated: 2020-02-20
• Results posted: 2020-02-05

Locations

1 site across 1 country: United States