Efficacy of Topical Cyclosporin for Ocular Rosacea | NCT00348335

Studies
Efficacy of Topical Cyclosporin for Ocular Rosacea

NCT00348335

Sponsor

Ophthalmic Consultants of Long Island

Status

Completed

Last Update Posted

Jul 29, 2011Estimated

Enrollment

35Actual

Phase

Phase 4

Conditions

Rosacea

Interventions

Cyclosporine 0.05%
Ocular lubricant

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jun 30, 2006

First Posted Date

Jul 4, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2011

Last Update Posted Date

Jul 29, 2011Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1: Restasis	Active Comparator		Drug: Cyclosporine 0.05%
2: Refresh Endura	Active Comparator		Drug: Ocular lubricant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclosporine 0.05%	Drug		1: Restasis
Ocular lubricant

Measure	Description	Time Frame
hyperemia		6 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John R Wittpenn, MD	Ophthalmic Consultants of Long Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
2500 Rte 347 Bldg 24		Stony Brook	New York	11790	United States

Condition Browse Module

MeSH Terms

ID	Term
D012393	Rosacea

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided