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Topical Cyclosporine vs. Placebo for Epiphora Associated With Docetaxel

NCT00824811 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2012-08-02

No results posted yet for this study

Summary

Objective:

To evaluate the safety and efficacy of topical cyclosporine eye drops (Restasis®) for the treatment of epiphora caused by canalicular stenosis secondary to Docetaxel (Taxotere®) treatment for various cancers.

Conditions

  • Epiphora

Interventions

DRUG

Cyclosporine Eye Drops (Restasis)

One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.

DRUG

Lubricant Eye Drops (Refresh Endura™)

One drop twice a day (approximately 12 hours between instillations) for 84 consecutive days to both eyes.

DRUG

Fluorometholone Eye Drops (FML Forte®)

Week 1: One drop four times a day to both eyes. Week 2: One drop three times a day to both eyes. Week 3: One drop twice a day to both eyes. Week 4: One drop once a day to both eyes. Wait at least 10 minutes after Restasis® or Refresh Endura™ instillation to instill FML Forte®.

Sponsors & Collaborators

  • Allergan

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Bita Esmaeli, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00824811 on ClinicalTrials.gov