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

January 8, 2013 updated by: Santen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Ophthalmic Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dose Group 1
Drug: Sirolimus
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
  • MS-R001, rapamycin
Drug: Sirolimus
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
  • MS-R003, rapamycin
Drug: Sirolimus
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
  • MS-R002, rapamycin
Drug: Sirolimus
Subconjunctival injection of placebo in each eye.
EXPERIMENTAL: Dose Group 2
Drug: Sirolimus
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
  • MS-R001, rapamycin
Drug: Sirolimus
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
  • MS-R003, rapamycin
Drug: Sirolimus
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
  • MS-R002, rapamycin
Drug: Sirolimus
Subconjunctival injection of placebo in each eye.
EXPERIMENTAL: Dose Group 3
Drug: Sirolimus
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
  • MS-R001, rapamycin
Drug: Sirolimus
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
  • MS-R003, rapamycin
Drug: Sirolimus
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
  • MS-R002, rapamycin
Drug: Sirolimus
Subconjunctival injection of placebo in each eye.
PLACEBO_COMPARATOR: Dose Group 4
Drug: Sirolimus
Subconjunctival injection of 440 micrograms sirolimus in each eye.
Other Names:
  • MS-R001, rapamycin
Drug: Sirolimus
Subconjunctival injection of 220 micrograms sirolimus in each eye.
Other Names:
  • MS-R003, rapamycin
Drug: Sirolimus
Subconjunctival injection of 880 micrograms sirolimus in each eye.
Other Names:
  • MS-R002, rapamycin
Drug: Sirolimus
Subconjunctival injection of placebo in each eye.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety across treatment groups.
Time Frame: Through 28 days
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.
Time Frame: Day 28
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen Inc.

Collaborators

MacuSight, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

December 23, 2008

First Submitted That Met QC Criteria

December 24, 2008

First Posted (ESTIMATE)

December 25, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 8, 2013

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DES-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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