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

Phase 2TerminatedNCT02013791

Allergan55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dry Eye Syndromes

Interventions

VehicleDRUG

Vehicle of cyclosporine administered as per protocol

ShamOTHER

Sham administered to non-study eye as per protocol on Day 1

Cyclosporine New Ophthalmic FormulationDRUG

Cyclosporine New Ophthalmic Formulation administered as per protocol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe dry eye disease in both eyes * Best-corrected visual acuity (BCVA) of 20/100 or better in each eye Exclusion Criteria: * Use of any cyclosporine preparations within 3 months * Use of topical medications, other than artificial tears, in the eyes within 1 month * Use of contact lenses in either eye within 1 month * Stage 2 only: Participation in Stage 1 of this study

Locations (8)

Sall Research Medical Center

Artesia, California, United States

Lugene Eye Institute

Glendale, California, United States

Lakeside Vision Center

Irvine, California, United States

Steve Yoelin MD Medical Asscociates

Newport Beach, California, United States

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs with an onset that occurs after receiving study drug.

Time frame: First dose of study drug to up to 24 Weeks

Data from ClinicalTrials.gov

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