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

Allergan

Status and phase: Terminated; Phase 2

Conditions: Dry Eye Syndromes

Treatments: Other: Sham; Drug: Vehicle; Drug: Cyclosporine New Ophthalmic Formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013791

192371-024

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 9 patient groups

Stage 1 Cohort 1

Other group

Description:

Vehicle administered to study eye and Sham administered to non-study eye on Day 1.

Treatment:

Other: Sham

Drug: Vehicle

Stage 1 Cohort 2

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation

Stage 1 Cohort 3

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation

Stage 1 Cohort 4

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation

Stage 1 Cohort 5A

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation

Stage 1 Cohort 6A

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation

Stage 1 Cohort 6B

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation

Stage 1 Cohort 6C

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation

Stage 1 Cohort 6D

Experimental group

Description:

Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1 and retreatment at Week 12 if applicable.

Treatment:

Drug: Vehicle

Drug: Cyclosporine New Ophthalmic Formulation