Dry Eye SyndromesPhase 2NCT00611403

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients

A Phase 2 study testing Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) and Artificial Tears REFRESH ENDURA® in people with Dry Eye Syndromes, 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.

Official record

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Trial summary

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery Read more about this study

Who is it for?: Ages 21 to 50 years
Conditions the study is for: Dry Eye Syndromes
What is being tested?: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) and Artificial Tears REFRESH ENDURA®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteUnited States
Study dates: Dec 2007to Jun 2009
Phase: Phase 2
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 21 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patient is scheduled for bilateral LASIK surgery
Patient is in good general health
Eye glasses prescription of -1 to -8

Who cannot join

Significant Dry Eye
Presence of eye disease
Uncontrolled systemic disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Overland Park, Kansas

Other trials in United States

About this study

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Conditions: Dry Eye Syndromes
Being tested: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®), Artificial Tears REFRESH ENDURA®
Keywords: LASIK
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% (RESTASIS®)Drug
Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
Artificial Tears REFRESH ENDURA®Drug
REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery

Study groups in NCT00611403
Study group	Role	What they receive
RESTASIS®	Active comparator	Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) Receives: Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA®	Active comparator	Artificial Tears (REFRESH ENDURA®) Receives: Drug: Artificial Tears REFRESH ENDURA®

What is being measured

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

Percentage of Patients With Clinical Success at Month 6
Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.
Measured: Month 6

Secondary outcomes (2)

Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
Change from baseline in keratocyte (specialized cells in the cornea activated after injury or inflammation) density (thickness) in the anterior flap of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. A positive number change from baseline represents an increase in density (improvement). A negative number change from baseline represents a decrease in density (worsening).
Measured: Baseline, Month 6
Change From Baseline in Goblet Cell Density of the Eyes at Month 6
Change from baseline in goblet cell density of the eyes (better eye and worse eye) at month 6 of the Treatment Phase. Goblet cells are special cells in the eye that support a healthy tear film. A positive number change from baseline represents an increase in goblet cells (improvement).
Measured: Baseline, Month 6

Timeline

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

Dec 2007Jun 2009

First posted8 Feb 2008 (estimated)
Study startDec 2007
Primary completionDec 2008
Study completionJun 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.
Other trials for Dry Eye SyndromesStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00611403
Sponsor's protocol ID: 192371-014
Status last verified: Nov 2011
First submitted: 28 Jan 2008
Last updated: 20 Dec 2011
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 Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients
ClinicalTrials.gov ID: NCT00611403
Acronym / sponsor ID: 192371-014
Conditions: Dry Eye Syndromes
Keywords: LASIK
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Dec 2008 (actual)
Study completion: Jun 2009 (actual)
First posted: 8 Feb 2008 (estimated)
Results: Posted 20 Dec 2011

Clinical summary

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

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
RESTASIS®	Active comparator	Drug: Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
REFRESH ENDURA®	Active comparator	Drug: Artificial Tears REFRESH ENDURA®Artificial Tears (REFRESH ENDURA®)

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patient is scheduled for bilateral LASIK surgery
Patient is in good general health
Eye glasses prescription of -1 to -8

Key exclusion criteria (3 listed)

Significant Dry Eye
Presence of eye disease
Uncontrolled systemic disease

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% (RESTASIS®)Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery	Drug	RESTASIS®
Artificial Tears REFRESH ENDURA®REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery	Drug	REFRESH ENDURA®

Primary outcome

Percentage of Patients With Clinical Success at Month 6
Time frame: Month 6
Percentage of patients with clinical success at month 6. Clinical success is defined as the percentage of patients with corneal sensitivity (the capability of the cornea to respond to stimulation) >= 50 millimeters in all regions of the study eye at month 6 of the Treatment Phase.

2 secondary outcomes

Change From Baseline in Keratocyte Density in the Anterior Flap of the Eyes at Month 6
Time frame: Baseline, Month 6
Change From Baseline in Goblet Cell Density of the Eyes at Month 6
Time frame: Baseline, Month 6

Results and safety

Results posted to the registry on 20 Dec 2011, 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®	68	62
REFRESH ENDURA®	69	58

Primary outcome: Percentage of Patients With Clinical Success at Month 6

Time frame: Month 6. Number. Unit: Percentage of Patients

Measure	RESTASIS® n = 42	REFRESH ENDURA® n = 43
Value	64.3	58.1

Population analysed: Modified Intent-to-Treat (mITT). The mITT population included all randomized and treated patients with a study eye having a corneal sensitivity measurement of \< 25 mm in the 3 central regions of the eye on Day 2.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RESTASIS®	1 of 68 (1.5%)	16 of 68 (23.5%)	Not reported
REFRESH ENDURA®	1 of 69 (1.4%)	8 of 69 (11.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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?

A Phase 2 study testing Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®) and Artificial Tears REFRESH ENDURA® in people with Dry Eye Syndromes, 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 3 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 20 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2011). 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 Clinical Success at Month 6 (time frame: Month 6). 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 NCT00611403.

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 20 Dec 2011.