NCT02013791

Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease

A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate a new ophthalmic formulation of cyclosporine (Restasis® X) in patients with moderate to severe dry eye disease in two stages. Up to 3 doses will be studied in Stage 2 based on results from Stage 1. No patients participating in Stage 1 will participate in Stage 2 of this study. This study was terminated and Stage 2 of the study was cancelled.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Vehicle	Vehicle of cyclosporine administered as per protocol
OTHER	Sham	Sham administered to non-study eye as per protocol on Day 1
DRUG	Cyclosporine New Ophthalmic Formulation	Cyclosporine New Ophthalmic Formulation administered as per protocol

Timeline

• Start date: 2014-04-29
• Primary completion: 2017-04-12
• Completion: 2017-04-12
• First posted: 2013-12-17
• Last updated: 2018-05-15
• Results posted: 2018-05-15

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study