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Efficacy of Topical Cyclosporine A for Treatment and Prevention of Graft Rejection in Corneal Grafts With Previous Rejection Episodes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028443
First Posted: December 9, 2009
Last Update Posted: December 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  Purpose
The use of topical Cyclosporine A early after an episode of endothelial graft rejection after penetrating keratoplasty and continuing its administration for 6 months can reduce the course of that episode and recurrence of the rejection.

Condition Intervention Phase
Endothelial Graft Rejection Drug: Sandimmune Drug: Artelose Phase 4

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • The rate of rejection after drop sessation [ Time Frame: 3 years ]

Arms Assigned Interventions
Active Comparator: Cyclosporine A 2% Drug: Sandimmune
Placebo Comparator: Artificial tears Drug: Artelose

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Penetrating keratoplasty in eyes without vascularization

Exclusion Criteria:

  • History of previous intraocular surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028443


Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 166666
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
  More Information

ClinicalTrials.gov Identifier: NCT01028443     History of Changes
Other Study ID Numbers: 8546
First Submitted: December 8, 2009
First Posted: December 9, 2009
Last Update Posted: December 9, 2009
Last Verified: April 2006

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors