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

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ClinicalTrials.gov Identifier: NCT02013791
Recruitment Status : Terminated
First Posted : December 17, 2013
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Vehicle Other: Sham Drug: Cyclosporine New Ophthalmic Formulation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-center, Vehicle- and Sham-controlled, Randomized Study of RESTASIS® X in Patients With Moderate to Severe Dry Eye Disease
Actual Study Start Date : April 29, 2014
Actual Primary Completion Date : April 12, 2017
Actual Study Completion Date : April 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: RESTASIS® X




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013791


Locations
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United States, California
Sall Research Medical Center
Artesia, California, United States, 90701
Lugene Eye Institute
Glendale, California, United States, 91204
Lakeside Vision Center
Irvine, California, United States, 92604
Steve Yoelin MD Medical Asscociates
Newport Beach, California, United States, 92663
Wolstan & Goldberg Eye Associates
Torrance, California, United States, 90505
United States, Colorado
Vision Institute
Colorado Springs, Colorado, United States, 80907
United States, Maryland
Johns Hopkins University - Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, Wisconsin
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States, 53142
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Eleonora Safyan Allergan
  Study Documents (Full-Text)

Documents provided by Allergan:
Study Protocol  [PDF] January 19, 2017
Statistical Analysis Plan  [PDF] June 20, 2017


Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02013791     History of Changes
Other Study ID Numbers: 192371-024
First Posted: December 17, 2013    Key Record Dates
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors