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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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