Efficacy of Topical Cyclosporin for Ocular Rosacea
![]() |
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. |
ClinicalTrials.gov Identifier: NCT00348335 |
Recruitment Status :
Completed
First Posted : July 4, 2006
Last Update Posted : July 29, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rosacea | Drug: Cyclosporine 0.05% Drug: Ocular lubricant | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 35 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea |
Study Start Date : | June 2006 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | September 2007 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1: Restasis |
Drug: Cyclosporine 0.05% |
Active Comparator: 2: Refresh Endura |
Drug: Ocular lubricant |
- hyperemia [ Time Frame: 6 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patient at least 18 years old, but younger than 65
- Diagnosis of acne rosacea
- Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia and hyperemia of at least 2+
- Schirmers test of greater than 5mm in at least 1 eye
- If patient currently using lid hygiene must maintain regimen during study
- Stop oral antibiotics at least 4 weeks prior
Exclusion Criteria:
- Use of topical cyclosporin within last 90 days
- Visual acuity of 20/100 or better in both eyes
- Pregnant or lactating females
- Active ocular infection
- Scarring of central cornea
- Eyelid defects,abnormal lid positioning or lagophthalmos
- Flax seed or Fish oil supplements within last 30 days

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): NCT00348335
United States, New York | |
2500 Rte 347 Bldg 24 | |
StonyBrook, New York, United States, 11790 |
Principal Investigator: | John R Wittpenn, MD | Ophthalmic Consultants of Long Island |
Responsible Party: | Dr. Eric Donnenfeld, OCLI |
ClinicalTrials.gov Identifier: | NCT00348335 |
Other Study ID Numbers: |
32,133 |
First Posted: | July 4, 2006 Key Record Dates |
Last Update Posted: | July 29, 2011 |
Last Verified: | July 2011 |
Rosacea Skin Diseases Cyclosporine Cyclosporins 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 |