CClinicalTrials.gg
Sign In
CompletedNCT00348335Updated Jul 29, 2011

Efficacy of Topical Cyclosporin for Ocular Rosacea

A Phase 4 interventional study of Cyclosporine 0.05% and Ocular lubricant in Rosacea, sponsored by Ophthalmic Consultants of Long Island. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-29.

Sponsored by Ophthalmic Consultants of Long Island · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Rosacea

Browse trials for

03

In context

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's enrollment of 35 is below the median of 61 across 195 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

Ophthalmic Consultants of Long Island is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
35 participants (actual)

Study arms

  • Active comparator
    1: Restasis

    Drug: Cyclosporine 0.05%

  • Active comparator
    2: Refresh Endura

    Drug: Ocular lubricant

Interventions

  • DrugCyclosporine 0.05%
  • DrugOcular lubricant
06

What researchers measure

Primary outcomes

  1. hyperemia

    Time frame: 6 months

07

Study locations

1 site
  • 2500 Rte 347 Bldg 24
    StonyBrook, New York 11790, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00348335
Lead sponsor
Ophthalmic Consultants of Long Island
Collaborators
Allergan
First posted
Jul 4, 2006
Start date
Jun 2006
Primary completion
Sep 2007
Completion
Sep 2007
Last update
Jul 29, 2011

Study contacts

John R Wittpenn, MD
principal investigator · Ophthalmic Consultants of Long Island

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rosacea→

Other studies from this sponsor

Ophthalmic Consultants of Long Island

Start the discussion