Efficacy of Topical Cyclosporin for Ocular Rosacea

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Cyclosporine 0.05%

Ocular lubricant

About this trial

This is an interventional treatment trial for Rosacea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

2500 Rte 347 Bldg 24

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

1: Restasis

2: Refresh Endura

Arm Description

Outcomes

Primary Outcome Measures

hyperemia

Secondary Outcome Measures

Full Information

NCT ID

NCT00348335

First Posted

June 30, 2006

Last Updated

July 28, 2011

Sponsor

Ophthalmic Consultants of Long Island

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT00348335

Brief Title

Efficacy of Topical Cyclosporin for Ocular Rosacea

Official Title

Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea

Study Type

Interventional

2. Study Status

Record Verification Date

July 2011

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Ophthalmic Consultants of Long Island

Collaborators

Allergan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea

Detailed Description

The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rosacea

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

35 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1: Restasis

Arm Type

Active Comparator

Arm Title

2: Refresh Endura

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Cyclosporine 0.05%

Intervention Type

Drug

Intervention Name(s)

Ocular lubricant

Primary Outcome Measure Information:

Title

hyperemia

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John R Wittpenn, MD

Organizational Affiliation

Ophthalmic Consultants of Long Island

Official's Role

Principal Investigator

Facility Information:

Facility Name

2500 Rte 347 Bldg 24

City

StonyBrook

State/Province

New York

ZIP/Postal Code

11790

Country

United States

Rosacea

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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