NCT00814944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 25, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 10, 2013

Status Verified

July 1, 2010

Enrollment Period

6 months

First QC Date

December 23, 2008

Last Update Submit

January 8, 2013

Conditions

Dry Eye

Keywords

dry eyesirolimusrapamycin

Outcome Measures

Primary Outcomes (2)

  • Mean corneal fluorescein staining (inferior region) after CAE exposure.

    Day 28

  • Mean ocular discomfort during CAE exposure.

    Day 28

Secondary Outcomes (2)

  • 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

Study Arms (4)

Dose Group 1

EXPERIMENTAL
Drug: Sirolimus

Dose Group 2

EXPERIMENTAL
Drug: Sirolimus

Dose Group 3

EXPERIMENTAL
Drug: Sirolimus

Dose Group 4

PLACEBO COMPARATOR
Drug: Sirolimus

Interventions

SirolimusDRUG

Subconjunctival injection of 440 micrograms sirolimus in each eye.

Also known as: MS-R001, rapamycin
Dose Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Have contraindications to the use of the study medications;
  • Have known allergy or sensitivity to the use of the study medications or diagnostic dyes;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Joel Naor, MD

    MacuSight, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2008

First Posted

December 25, 2008

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 10, 2013

Record last verified: 2010-07

Locations

US(1)