NCT04555694

Comparing Treatment of Dry Eye With Intracanalicular Dexamethasone, Restasis, and/or Lotemax

Intracanalicular Dexamethasone Used in Conjunction With Restasis (Cyclosporine Ophthalmic Emulsion) for the Treatment of Signs and Symptoms of Dry Eye Disease as Compared to Restasis With Lotemax (Loteprednol Etabonate Ophthalmic Suspension 0.5%) and Restasis Monotherapy.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Thomas Chester, OD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This 6 month study seeks to compare the use of Intracanalicular Dexamethasone in conjunction with Restasis (cyclosporine ophthalmic emulsion) for the treatment of signs and symptoms of dry eye disease as compared to Restasis with Lotemax (loteprednol etabonate ophthalmic suspension 0.5%) and Restasis monotherapy.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	Cyclosporine	Used to increase tear production in patients who have dry eye caused by inflammation
DRUG	Loteprednol Etabonate	Used to treat inflammation of the eye
DRUG	Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert	Used to treat inflammation of the eye

Timeline

• Start date: 2020-10-01
• Primary completion: 2022-02-16
• Completion: 2022-02-16
• First posted: 2020-09-21
• Last updated: 2023-10-11
• Results posted: 2023-10-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study