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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

This study has been completed.
Sponsor:
Collaborator:
MacuSight, Inc.
Information provided by (Responsible Party):
Santen Inc.
ClinicalTrials.gov Identifier:
NCT00814944
First received: December 23, 2008
Last updated: January 8, 2013
Last verified: July 2010

December 23, 2008
January 8, 2013
April 2009
October 2009   (final data collection date for primary outcome measure)
  • Mean corneal fluorescein staining (inferior region) after CAE exposure. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Mean ocular discomfort during CAE exposure. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00814944 on ClinicalTrials.gov Archive Site
  • Safety across treatment groups. [ Time Frame: Through 28 days ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dry Eye
  • Drug: Sirolimus
    Subconjunctival injection of 440 micrograms sirolimus in each eye.
    Other Name: MS-R001, rapamycin
  • Drug: Sirolimus
    Subconjunctival injection of 220 micrograms sirolimus in each eye.
    Other Name: MS-R003, rapamycin
  • Drug: Sirolimus
    Subconjunctival injection of 880 micrograms sirolimus in each eye.
    Other Name: MS-R002, rapamycin
  • Drug: Sirolimus
    Subconjunctival injection of placebo in each eye.
  • Experimental: Dose Group 1
    Intervention: Drug: Sirolimus
  • Experimental: Dose Group 2
    Intervention: Drug: Sirolimus
  • Experimental: Dose Group 3
    Intervention: Drug: Sirolimus
  • Placebo Comparator: Dose Group 4
    Intervention: Drug: Sirolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
143
October 2009
October 2009   (final data collection date for primary outcome measure)

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;
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00814944
DES-001
No
Santen Inc.
Santen Inc.
MacuSight, Inc.
Study Director: Joel Naor, MD MacuSight, Inc.
Santen Inc.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP