A Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation compared to Placebo on the signs and symptoms of dry eye in the CAE Model.

Official Title
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A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Ranging Clinical Study to Assess the Safety and Efficacy of Subconjunctival Injection of Sirolimus in Patients With Dry Eye in the Controlled Adverse Environmental (CAE) Model

Conditions
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Dry Eye

Intervention / Treatment
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* Drug: Sirolimus
* Drug: Sirolimus
* Drug: Sirolimus
* Drug: Sirolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria include, but are not limited to: Have a reported history of dry eye in both eyes; Have a history of use of or desire to use an eye drop for dry eye symptoms within the past 6 months. Exclusion Criteria include, but are not limited to: Have contraindications to the use of the study medications; Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Group 1<br> | Drug: Sirolimus<br>* Subconjunctival injection of 220 micrograms sirolimus in each eye.<br>* Other names: MS-R003, rapamycin;|
| Experimental: Dose Group 2<br> | Drug: Sirolimus<br>* Subconjunctival injection of 440 micrograms sirolimus in each eye.<br>* Other names: MS-R001, rapamycin;|
| Experimental: Dose Group 3<br> | Drug: Sirolimus<br>* Subconjunctival injection of 880 micrograms sirolimus in each eye.<br>* Other names: MS-R002, rapamycin;|
| Placebo Comparator: Dose Group 4<br> | Drug: Sirolimus<br>* Subconjunctival injection of placebo in each eye.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean corneal fluorescein staining (inferior region) after CAE exposure. |  | Day 28 | 
| Mean ocular discomfort during CAE exposure. |  | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety across treatment groups. |  | Through 28 days | 
| Additional evaluations of dry eye including fluorescein staining, lissamine green staining, conjunctival redness, tear film break-up time, blink rate, ocular protection index, Schirmer's Test, and corneal sensitivity. |  | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dry eye, sirolimus, rapamycin