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

April 12, 2018 updated by: Allergan

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Artesia, California, United States, 90701
        • Sall Research Medical Center
      • Glendale, California, United States, 91204
        • Lugene Eye Institute
      • Irvine, California, United States, 92604
        • Lakeside Vision Center
      • Newport Beach, California, United States, 92663
        • Steve Yoelin MD Medical Asscociates
      • Torrance, California, United States, 90505
        • Wolstan & Goldberg Eye Associates
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Vision Institute
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University - Wilmer Eye Institute
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Eye Centers of Racine and Kenosha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stage 1 Cohort 1
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Other: Sham
Sham administered to non-study eye as per protocol on Day 1
Experimental: Stage 1 Cohort 2
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X
Experimental: Stage 1 Cohort 3
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X
Experimental: Stage 1 Cohort 4
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X
Experimental: Stage 1 Cohort 5A
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X
Experimental: Stage 1 Cohort 6A
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X
Experimental: Stage 1 Cohort 6B
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X
Experimental: Stage 1 Cohort 6C
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.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X
Experimental: Stage 1 Cohort 6D
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.
Drug: Vehicle
Vehicle of cyclosporine administered as per protocol
Drug: Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol
Other Names:
  • RESTASIS® X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: First dose of study drug to up to 24 Weeks
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.
First dose of study drug to up to 24 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Corneal Staining Score Using a 6-Point Scale
Time Frame: Baseline (Day 1) to Week 12

Total corneal staining with sodium fluorescein was measured in the study eye using the 6-point Oxford scale [Grade 0: <2 dots (best), Grade 1: ≥2 to ≤10 dots, Grade 2: >10 to ≤32 dots, Grade 3: >32 to ≤100 dots, Grade 4: >100 to ≤316 dots and Grade 5: >316 dots or ulcer/erosion (worst)]. The study eye was defined as the eye that received the dosing level of the treatment received. A negative change from Baseline represents a decrease in staining (improvement).

Corneal Staining Score was originally registered as a Primary endpoint but it is actually an exploratory endpoint.
Baseline (Day 1) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2014

Primary Completion (Actual)

April 12, 2017

Study Completion (Actual)

April 12, 2017

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 12, 2013

First Posted (Estimate)

December 17, 2013

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

April 12, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 192371-024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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