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

Dry Eye Syndromes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02013791
• Other study ID #: 192371-024
• Status: Terminated
• Phase: Phase 2
• Start date: April 29, 2014
• Est. completion date: April 12, 2017

Study information

• Verified date: April 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: April 12, 2017
• Est. primary completion date: April 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Vehicle
Vehicle of cyclosporine administered as per protocol

Other:
• Sham
Sham administered to non-study eye as per protocol on Day 1

Drug:
• Cyclosporine New Ophthalmic Formulation
Cyclosporine New Ophthalmic Formulation administered as per protocol

Locations

Country	Name	City	State
United States	Sall Research Medical Center	Artesia	California
United States	Johns Hopkins University - Wilmer Eye Institute	Baltimore	Maryland
United States	Vision Institute	Colorado Springs	Colorado
United States	Lugene Eye Institute	Glendale	California
United States	Lakeside Vision Center	Irvine	California
United States	Eye Centers of Racine and Kenosha	Kenosha	Wisconsin
United States	Steve Yoelin MD Medical Asscociates	Newport Beach	California
United States	Wolstan & Goldberg Eye Associates	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in Corneal Staining Score Using a 6-Point Scale	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
Primary	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.	First dose of study drug to up to 24 Weeks

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