Keratoconjunctivitis SiccaNCT00717418

Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease

An observational study of Keratoconjunctivitis Sicca, 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

This study will evaluate the efficacy of cyclosporine ophthalmic solution vs. other non-prescription treatments in patients with dry eye disease. Patient and physician assessments completed at baseline, at each follow-up visit (follow-up visits are variable as per physician discretion) and at final follow-up visit. Read more about this study

Who is it for?: Any age
Conditions the study is for: Keratoconjunctivitis Sicca
What is being tested?: cyclosporine ophthalmic emulsion 0.05%, artificial tears
How many people: 781 participants
Where: 1 siteUnited States
Study dates: Sep 2004to Aug 2008
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Patients can either: 1. be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment 2. have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments

Who may be able to join

Diagnosis of dry eye disease
Currently using artificial tears daily
Male or female of legal age of consent
Normal lid position and closure

Who cannot join

Patients currently using cyclosporine ophthalmic emulsion 0.05%
Participation in other investigational drug or device study
Any current or previous topical ophthalmic or oral cyclosporine use within the last three years

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Wilson, North Carolina

Other trials in United States

About this study

Conditions: Keratoconjunctivitis Sicca
Being tested: cyclosporine ophthalmic emulsion 0.05%, artificial tears
Medical subject headings: Keratoconjunctivitis Sicca

What participants receive

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

cyclosporine ophthalmic emulsion 0.05%, artificial tearsDrug
Also called Restasis®
one drop, twice a day in each eye

Study groups in NCT00717418
Study group	Role	What they receive
1		* cyclosporine ophthalmic emulsion 0.05% * artificial tears Receives: Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears

What is being measured

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

Ocular Surface Disease Index (OSDI) Total Score at Baseline
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).
Measured: Baseline

Timeline

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

Sep 2004Aug 2008

First posted17 Jul 2008 (estimated)
Study startSep 2004
Primary completionAug 2006
Study completionAug 2008

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.
Other trials for Keratoconjunctivitis SiccaStudies 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: Cohort
Time perspective: Prospective
Enrolment: 781 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00717418
Sponsor's protocol ID: R.E.S.T.O.R.E.
Status last verified: Dec 2011
First submitted: 14 Jul 2008
Last updated: 12 Jan 2012
Results posted: Yes, on ClinicalTrials.gov

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 Keratoconjunctivitis Sicca trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy Study of Cyclosporine Ophthalmic Emulsion in Patients With Dry Eye Disease
ClinicalTrials.gov ID: NCT00717418
Acronym / sponsor ID: R.E.S.T.O.R.E.
Conditions: Keratoconjunctivitis Sicca
Study type: Observational
Recruitment status: Completed
Enrolment: 781 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Sep 2004
Primary completion: Aug 2006 (actual)
Study completion: Aug 2008 (actual)
First posted: 17 Jul 2008 (estimated)
Results: Posted 12 Jan 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: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Drug: cyclosporine ophthalmic emulsion 0.05%, artificial tears* cyclosporine ophthalmic emulsion 0.05% * artificial tears

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients can either: 1. be newly diagnosed or changing therapies and require, in the judgment of the treating physician, a prescription treatment 2. have insufficiently controlled dry eye symptoms necessitating use of over-the-counter treatments

Key inclusion criteria (4 listed)

Diagnosis of dry eye disease
Currently using artificial tears daily
Male or female of legal age of consent
Normal lid position and closure

Key exclusion criteria (3 listed)

Patients currently using cyclosporine ophthalmic emulsion 0.05%
Participation in other investigational drug or device study
Any current or previous topical ophthalmic or oral cyclosporine use within the last three years

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%, artificial tearsAlso: Restasis®one drop, twice a day in each eye	Drug	1

Primary outcome

Ocular Surface Disease Index (OSDI) Total Score at Baseline
Time frame: Baseline
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst).

Results and safety

Results posted to the registry on 12 Jan 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
Restasis® Alone	180	180
Artificial Tears Alone	74	74
Combination Treatments	508	508
Missing Treatment Information	19	4

Primary outcome: Ocular Surface Disease Index (OSDI) Total Score at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	All Patients n = 750
Value	40.3 (22.0)

Population analysed: Intent-to-treat, which included all patients who started the study (completed baseline visit) and were assessed for this outcome measure. 16 subjects did not complete this outcome measure assessment and were not included in the analysis.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): Due to actual dry eye treatment used, data were not interpretable by separate treatment arms. Hence, Outcomes are only reported as a single group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Keratoconjunctivitis Sicca

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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RecruitingObservational study
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RecruitingObservational study
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Not yet recruitingPhase 2
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Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)

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 Keratoconjunctivitis Sicca, 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 4 inclusion and 3 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 12 Jan 2012. 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 12 Jan 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?

Ocular Surface Disease Index (OSDI) Total Score at Baseline (time frame: Baseline). 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 NCT00717418.

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 12 Jan 2012.