Dry Eye DiseaseNCT00827255

Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%

An observational study of Dry Eye Disease, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this retrospective chart review is to evaluate the patient characteristics, treatment variations and efficacy of a second trial of Cyclosporine Ophthalmic Emulsion 0.05% therapy in chronic dry eye patients who were initially treated with Cyclosporine Ophthalmic Emulsion 0.05% but discontinued use… Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Dry Eye Disease
What is being tested?: Cyclosporine Ophthalmic Emulsion 0.05%
How many people: 35 participants
Where: 1 siteUnited States
Study dates: Jan 2009to Oct 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: The medical charts of all chronic dry eye patients who discontinued their first trial of RESTASIS® after less than 12 weeks of treatment and who started a second trial of RESTASIS® prior to June 1, 2008 will be included in the review.

Who may be able to join

Adults >16 years of age
Dry eye patients
Subject with history of less than 12 weeks of initial RESTASIS® treatment
Subject started second trial of RESTASIS® treatment prior to June 1, 2008
First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment

Who cannot join

Patients with Contact Lens Intolerance
Patients with Ocular Rosacea

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Pittsburgh, Pennsylvania

Other trials in United States

About this study

Conditions: Dry Eye Disease
Being tested: Cyclosporine Ophthalmic Emulsion 0.05%
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cyclosporine Ophthalmic Emulsion 0.05%Drug
Also called RESTASIS®
One drop two times a day approximately 12 hours apart

Study groups in NCT00827255
Study group	Role	What they receive
Patients who received Restasis®		Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%) Receives: Drug: Cyclosporine Ophthalmic Emulsion 0.05%

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients With Complete Clearing of Corneal Staining at Month 12
Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.
Measured: Month 12

Secondary outcomes (1)

Schirmer's Test at Month 12
Schirmer's test at month 12. The Schirmer's tear test is performed on the eye with or without anesthesia (numbing eye drop). The amount of tears produced by the eye in 5 minutes is measured in millimeters by means of a graduated paper scale. Data not reported due to limited number of patients with Schirmer's test data recorded.
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Oct 2009

First posted22 Jan 2009 (estimated)
Study startJan 2009
Primary completionJun 2009
Study completionOct 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye DiseaseStudies 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: Observational
Observational model: Case only
Time perspective: Retrospective
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00827255
Sponsor's protocol ID: MA-RES-08-002
Status last verified: Apr 2019
First submitted: 20 Jan 2009
Last updated: 25 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis((R)) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-6. doi: 10.2147/OPTH.S30261. Epub 2012 Nov 28.
PubMed 23226002

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physician's Evaluation of Cyclosporine Ophthalmic Emulsion 0.05%
ClinicalTrials.gov ID: NCT00827255
Acronym / sponsor ID: MA-RES-08-002
Conditions: Dry Eye Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Jun 2009 (actual)
Study completion: Oct 2009 (actual)
First posted: 22 Jan 2009 (estimated)
Results: Posted 18 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Patients who received Restasis®	–	Drug: Cyclosporine Ophthalmic Emulsion 0.05%Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: The medical charts of all chronic dry eye patients who discontinued their first trial of RESTASIS® after less than 12 weeks of treatment and who started a second trial of RESTASIS® prior to June 1, 2008 will be included in the review.

Key inclusion criteria (5 listed)

Adults >16 years of age
Dry eye patients
Subject with history of less than 12 weeks of initial RESTASIS® treatment
Subject started second trial of RESTASIS® treatment prior to June 1, 2008
First day of second trial of RESTASIS® started ≥ 4 weeks after the last day of previous RESTASIS® treatment

Key exclusion criteria (2 listed)

Patients with Contact Lens Intolerance
Patients with Ocular Rosacea

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 Ophthalmic Emulsion 0.05%Also: RESTASIS®One drop two times a day approximately 12 hours apart	Drug	Patients who received Restasis®

Primary outcome

Percentage of Patients With Complete Clearing of Corneal Staining at Month 12
Time frame: Month 12
Percentage of patients with complete clearing of corneal staining at month 12. Corneal staining is evaluated following administration of fluorescein dye into the eye. Complete clearing is defined as the absence of corneal staining.

1 secondary outcome

Schirmer's Test at Month 12
Time frame: Month 12

Results and safety

Results posted to the registry on 18 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients Who Received Restasis®	35	35

Primary outcome: Percentage of Patients With Complete Clearing of Corneal Staining at Month 12

Time frame: Month 12. Number. Unit: Percentage of Patients

Measure	Patients Who Received Restasis® n = 18
Value	33.3

Population analysed: ITT population, which consisted of all patients included in the study, with documented presence of corneal staining at baseline. For this outcome measure, a total of 18 patients had documented corneal staining at baseline.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients Who Received Restasis®	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 23226002Mah F, Milner M, Yiu S, Donnenfeld E, Conway TM, Hollander DA. PERSIST: Physician's Evaluation of Restasis((R)) Satisfaction in Second Trial of topical cyclosporine ophthalmic emulsion 0.05% for dry eye: a retrospective review. Clin Ophthalmol. 2012;6:1971-6. doi: 10.2147/OPTH.S30261. Epub 2012 Nov 28.

Related trials for Dry Eye Disease

Not yet recruitingPhase 1
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Sjogren's Syndrome, Sjögren
RecruitingPhase 1
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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.

Medical Director study director

Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye Disease, run by Allergan 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 5 inclusion and 2 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 25 Apr 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients With Complete Clearing of Corneal Staining at Month 12 (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00827255, which also lists 1 linked publication.

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 25 Apr 2019.