search
Back to results

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

Primary Purpose

Dry Eye Syndromes

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vehicle
Sham
Cyclosporine New Ophthalmic Formulation
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sall Research Medical Center
  • Lugene Eye Institute
  • Lakeside Vision Center
  • Steve Yoelin MD Medical Asscociates
  • Wolstan & Goldberg Eye Associates
  • Vision Institute
  • Johns Hopkins University - Wilmer Eye Institute
  • Eye Centers of Racine and Kenosha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Other

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Stage 1 Cohort 1

Stage 1 Cohort 2

Stage 1 Cohort 3

Stage 1 Cohort 4

Stage 1 Cohort 5A

Stage 1 Cohort 6A

Stage 1 Cohort 6B

Stage 1 Cohort 6C

Stage 1 Cohort 6D

Arm Description

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

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

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

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

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

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

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

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2013
Last Updated
April 12, 2018
Sponsor
Allergan
search

1. Study Identification

Unique Protocol Identification Number
NCT02013791
Brief Title
Phase 2 Study of a New Ophthalmic Formulation of Cyclosporine (Restasis® X) in Patients With Dry Eye Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Terminated
Study Start Date
April 29, 2014 (Actual)
Primary Completion Date
April 12, 2017 (Actual)
Study Completion Date
April 12, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 Cohort 1
Arm Type
Other
Arm Description
Vehicle administered to study eye and Sham administered to non-study eye on Day 1.
Arm Title
Stage 1 Cohort 2
Arm Type
Experimental
Arm Description
Cyclosporine New Ophthalmic Formulation Dose A administered to study eye and Vehicle administered to non-study eye on Day 1.
Arm Title
Stage 1 Cohort 3
Arm Type
Experimental
Arm Description
Cyclosporine New Ophthalmic Formulation Dose B administered to study eye and Vehicle administered to non-study eye on Day 1.
Arm Title
Stage 1 Cohort 4
Arm Type
Experimental
Arm Description
Cyclosporine New Ophthalmic Formulation Dose C administered to study eye and Vehicle administered to non-study eye on Day 1.
Arm Title
Stage 1 Cohort 5A
Arm Type
Experimental
Arm Description
Cyclosporine New Ophthalmic Formulation Dose D administered to the study eye and vehicle administered to the non-study eye on Day 1.
Arm Title
Stage 1 Cohort 6A
Arm Type
Experimental
Arm Description
Cyclosporine New Ophthalmic Formulation Dose E administered to study eye and Vehicle administered to non-study eye on Day 1.
Arm Title
Stage 1 Cohort 6B
Arm Type
Experimental
Arm Description
Cyclosporine New Ophthalmic Formulation Dose F administered to study eye and Vehicle administered to non-study eye on Day 1.
Arm Title
Stage 1 Cohort 6C
Arm Type
Experimental
Arm 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.
Arm Title
Stage 1 Cohort 6D
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle of cyclosporine administered as per protocol
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham administered to non-study eye as per protocol on Day 1
Intervention Type
Drug
Intervention Name(s)
Cyclosporine New Ophthalmic Formulation
Other Intervention Name(s)
RESTASIS® X
Intervention Description
Cyclosporine New Ophthalmic Formulation administered as per protocol
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Corneal Staining Score Using a 6-Point Scale
Description
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.
Time Frame
Baseline (Day 1) to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleonora Safyan
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Lugene Eye Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Lakeside Vision Center
City
Irvine
State/Province
California
ZIP/Postal Code
92604
Country
United States
Facility Name
Steve Yoelin MD Medical Asscociates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Wolstan & Goldberg Eye Associates
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Vision Institute
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Johns Hopkins University - Wilmer Eye Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Eye Centers of Racine and Kenosha
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.allerganclinicaltrials.com
Description
More Information

Learn more about this trial

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

We'll reach out to this number within 24 hrs