Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome

Study Overview
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Brief Summary
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A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.

Detailed Description
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This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.

Official Title
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A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)

Conditions
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Dry Eye Syndrome, Keratoconjunctivitis Sicca

Intervention / Treatment
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* Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)
* Drug: 0.10% VOS
* Drug: 0.20% VOS
* Drug: Vehicle Ophthalmic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age. Have a documented history of Dry Eye prior to Visit 1. Willing and able to follow protocol procedures and instructions. Exclusion criteria: Have undergone cataract or LASIK surgery within 1 year prior to Visit 1. Recent or current evidence of infection or inflammation in either eye. Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye. Have used any investigational drug or device within 30 days prior to Visit 1. Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1. Have worn contact lenses 24 hours prior to Visit 1. Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1. Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to one of the following treatment groups: Investigational product (IP): one drop 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks, one drop 0.10% VOS OU BID over 12 weeks, or one drop 0.20% VOS OU BID over 12 weeks. Comparator: one drop VOS vehicle OU BID over 12 weeks.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.05% Voclosporin Ophthalmic Solution (VOS)<br>0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks | Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)<br>* 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks<br>|
| Experimental: 0.10% VOS<br>0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks | Drug: 0.10% VOS<br>* 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks<br>|
| Experimental: 0.20% VOS<br>0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks | Drug: 0.20% VOS<br>* 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks<br>|
| Placebo Comparator: Vehicle Ophthalmic Solution<br>Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks | Drug: Vehicle Ophthalmic Solution<br>* Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) | Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale. | 4 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Eye Dryness | Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥ 60 mm. Eye Dryness Visual Analogue Scale 0-100 mm, where 0 corresponds to no discomfort and 100 corresponds to maximal discomfort. | Value at 4 Weeks minus value at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Calcineurin Inhibitors, Dry Eye Disease