Ocular Tolerability of Voclosporin Ophthalmic Solution Versus Restasis® in Subjects With Dry Eye Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2018-12-13

Brief Summary

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Evaluate the tolerability, efficacy and safety of VOS versus Restasis® in subjects with mild to moderate Dry Eye Disease (DED).

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Detailed Description

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This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase 2, multi-center, Investigator-masked, randomized, parallel-group study to evaluate the tolerability, efficacy and safety of VOS versus Restasis® over a 28-day treatment period in subjects with mild to moderate DED. Approximately 90 subjects will be randomized to either VOS or Restasis® at approximately 7 centers located in the US.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Voclosporin ophthalmic solution (VOS)

0.2% VOS, Twice Daily (BID), both eyes for 28 days

Group Type EXPERIMENTAL

Voclosporin Ophthalmic Solution

Intervention Type DRUG

Investigational Drug

Comparator

0.05% cyclosporine ophthalmic emulsion (Restasis®) BID, both eyes for 28 days

Group Type ACTIVE_COMPARATOR

Restasis®

Intervention Type DRUG

Comparator

Interventions

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Voclosporin Ophthalmic Solution

Investigational Drug

Intervention Type DRUG

Restasis®

Comparator

Intervention Type DRUG

Other Intervention Names

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0.2% VOS RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%

Eligibility Criteria

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Inclusion Criteria

1. Have a best corrected visual acuity (BCVA) in both eyes of +0.7 logarithm of the Minimum Angle of Resolution (logMAR) or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) chart.
2. Have a documented history of DED in both eyes supported by a previous clinical diagnosis.
3. Have ongoing DED, as defined by at least one eye (if one eye, the same eye) meeting all the following criteria:

* A symptom severity score of ≥30 for Eye Dryness on a Visual Analog Scale (VAS) (0-100)
* An unanesthetized Schirmer Tear Test (STT) score of ≥1 mm and ≤10 mm per 5 minutes (Note: STT Score obtained at Visit 1)
* Evidence of ocular surface staining (total fluorescein staining score of at least 3 \[0-15 scale\]).
4. Have normal lid anatomy.

Exclusion Criteria

1. Have any known hypersensitivity or contraindication to study treatments (including excipients), topical anesthetics or vital dyes.
2. Be unable to demonstrate correct instillation of over-the-counter (OTC) ocular lubricant.
3. Report discomfort in both eyes from instillation of OTC ocular lubricant during Visit 2 (based on score of ≥30 on the Drop Discomfort VAS).
4. Have used Restasis® (cyclosporine ophthalmic emulsion) within 30 days prior to Visit 1.
5. Have used Restasis® for more than 1 month (if prior use is reported).
6. Have used Xiidra® (lifitegrast ophthalmic solution) within 14 days prior to Visit 1.
7. Have had corneal graft surgery in either eye within 1 year.
8. Have recent or current evidence of ocular infection or inflammation in either eye.
9. Have current evidence of clinically significant blepharitis (defined as requiring lid hygiene therapy), conjunctivitis, or a history of herpes simplex or zoster keratitis in either eye.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No