RosaceaPhase 4NCT00348335
Efficacy of Topical Cyclosporin for Ocular Rosacea
A Phase 4 study testing Cyclosporine 0.05% and Ocular lubricant in people with Rosacea, run by Ophthalmic Consultants of Long Island at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rosacea
- What is being tested?
- Cyclosporine 0.05% and Ocular lubricant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Sep 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea
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
- Conditions
- Rosacea
- Being tested
- Cyclosporine 0.05%, Ocular lubricant
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine 0.05%Drug
Ocular lubricantDrug
| Study group | Role | What they receive |
|---|---|---|
| 1: Restasis | Active comparator | Not described Receives: Drug: Cyclosporine 0.05% |
| 2: Refresh Endura | Active comparator | Not described Receives: Drug: Ocular lubricant |
What is being measured
The primary outcome is the main question the study is designed to answer.
hyperemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJun 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RosaceaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Long Island
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Investigators
- John R Wittpenn, MD, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348335
- Sponsor's protocol ID
- 32,133
- Status last verified
- Jul 2011
- First submitted
- 30 Jun 2006
- Last updated
- 29 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea
- ClinicalTrials.gov ID
- NCT00348335
- Acronym / sponsor ID
- 32,133
- Conditions
- Rosacea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ophthalmic Consultants of Long IslandUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Jun 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Restasis | Active comparator | Drug: Cyclosporine 0.05% |
| 2: Refresh Endura | Active comparator | Drug: Ocular lubricant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclosporine 0.05% | Drug | 1: Restasis |
| Ocular lubricant | Drug | 2: Refresh Endura |
Primary outcome
hyperemia
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John R Wittpenn, MD principal investigator
Ophthalmic Consultants of Long Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cyclosporine 0.05% and Ocular lubricant in people with Rosacea, run by Ophthalmic Consultants of Long Island at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hyperemia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2011.