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

Santen

Status and phase: Completed; Phase 2

Conditions: Dry Eye

Treatments: Drug: Sirolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814944

DES-001

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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143 participants in 4 patient groups, including a placebo group

Dose Group 1

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

Dose Group 2

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

Dose Group 3

Experimental group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

Dose Group 4

Placebo Comparator group

Treatment:

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus

Drug: Sirolimus