NCT00348335

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

June 30, 2006

Last Update Submit

July 28, 2011

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • hyperemia

    6 months

Study Arms (2)

1: Restasis

ACTIVE COMPARATOR
Drug: Cyclosporine 0.05%

2: Refresh Endura

ACTIVE COMPARATOR
Drug: Ocular lubricant

Interventions

Cyclosporine 0.05%DRUG
1: Restasis
Ocular lubricantDRUG
2: Refresh Endura

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2500 Rte 347 Bldg 24

Stony Brook, New York, 11790, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • John R Wittpenn, MD

    Ophthalmic Consultants of Long Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

US(1)