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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00814944

Enrollment

143

Registered

2008-12-25

Start date

2009-04-30

Completion date

2009-10-31

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

dry eye, sirolimus, rapamycin

Brief summary

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.

Interventions

DRUGSirolimus

Subconjunctival injection of 440 micrograms sirolimus in each eye.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
Mean corneal fluorescein staining (inferior region) after CAE exposure.	Day 28
Mean ocular discomfort during CAE exposure.	Day 28

Secondary

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026