Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
Shahid Beheshti Medical University Identifier:
First received: December 8, 2009
Last updated: NA
Last verified: April 2006
History: No changes posted

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 Medical University:

Primary Outcome Measures:
  • The rate of rejection after drop sessation [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both

Inclusion Criteria:

  • Penetrating keratoplasty in eyes without vascularization

Exclusion Criteria:

  • History of previous intraocular surgery
  Contacts and Locations
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Please refer to this study by its identifier: NCT01028443

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 Medical University
  More Information

No publications provided Identifier: NCT01028443     History of Changes
Other Study ID Numbers: 8546
Study First Received: December 8, 2009
Last Updated: December 8, 2009
Health Authority: Iran: Ethics Committee processed this record on March 03, 2015