Dry Eye DiseasePhase 2NCT01276223

Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

A Phase 2 study testing Difluprednate 0.05% ophthalmic emulsion in people with Dry Eye Disease, run by Alcon Research 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

The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye Disease
What is being tested?: Difluprednate 0.05% ophthalmic emulsion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 722 participants
Where: 1 siteUnited States
Study dates: Feb 2011to Jan 2012
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Normal subjects:
No known history of dry eye disease.
Non-contact lens wearer.
No current use of artificial tears or any other dry eye treatment.
OR
Dry eye patients:

Show all 11Show fewer

At least a 6 month history of dry eye.
Non-contact lens wearer.
Uses artificial tears.
Experiences persistent ocular discomfort.
Other protocol-defined inclusion criteria may apply.

Who cannot join

The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
Severe Sjogren's Syndrome.
Lid function abnormalities.
Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
History of corneal surgery including refractive surgeries.
History of glaucoma or ocular hypertension
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye

Read the detailed description

Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Conditions: Dry Eye Disease
Being tested: Difluprednate 0.05% ophthalmic emulsion, Difluprednate vehicle
Keywords: Dry eye, ocular discomfort
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.

Difluprednate 0.05% ophthalmic emulsionDrug
Also called DUREZOL™
Topical ocular steroid
Difluprednate vehicleOther
Inactive ingredients used as Run-In and placebo comparator

Study groups in NCT01276223
Study group	Role	What they receive
Durezol	Experimental	Difluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure. Receives: Drug: Difluprednate 0.05% ophthalmic emulsion
Vehicle	Placebo comparator	Difluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week. Receives: Other: Difluprednate vehicle

What is being measured

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

Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).
Measured: Baseline, up to 4 weeks

Timeline

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

Feb 2011Jan 2012

First posted13 Jan 2011 (estimated)
Study startFeb 2011
Primary completionJan 2012
Study completionJan 2012

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 DiseaseStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 722 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01276223
Sponsor's protocol ID: C-10-078
Status last verified: Mar 2013
First submitted: 11 Jan 2011
Last updated: 11 Mar 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Center, Randomized, Double-Masked Evaluation of Anti-Inflammatory Treatment in Patients With Dry Eye
ClinicalTrials.gov ID: NCT01276223
Acronym / sponsor ID: C-10-078
Conditions: Dry Eye Disease
Keywords: Dry eye, ocular discomfort
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 722 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Feb 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 13 Jan 2011 (estimated)
Results: Posted 11 Mar 2013

Clinical summary

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

Detailed description

Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Study design

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

Arm	Type	Receives
Durezol	Experimental	Drug: Difluprednate 0.05% ophthalmic emulsionDifluprednate 0.05% ophthalmic emulsion, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week to allow for tapering of the steroid exposure.
Vehicle	Placebo comparator	Other: Difluprednate vehicleDifluprednate vehicle, 1 drop to the study eye 2 times a day for 4 weeks, followed by 1 drop to the study eye once daily for 1 week.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

No known history of dry eye disease.
Non-contact lens wearer.
No current use of artificial tears or any other dry eye treatment.
OR
At least a 6 month history of dry eye.

Key exclusion criteria (7 listed)

The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
Severe Sjogren's Syndrome.
Lid function abnormalities.
Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
History of corneal surgery including refractive surgeries.

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
Difluprednate 0.05% ophthalmic emulsionAlso: DUREZOL™Topical ocular steroid	Drug	Durezol
Difluprednate vehicleInactive ingredients used as Run-In and placebo comparator	Other	Vehicle

Primary outcome

Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks
Time frame: Baseline, up to 4 weeks
A Visual Analog Scale (VAS) was used by the subject to assess ocular discomfort, both frequency and severity, at baseline (pre-treatment) and weekly thereafter for 4 additional weeks. Each scale was 100 millimeters (mm) in length. The VAS score was calculated by measuring the length in mm from the start of the line to the intersection point of the vertical mark made by the subject. The Global Ocular Discomfort Score is a composite of the two VAS scores, ranging from 0 (very mildly) to 100 (very severely uncomfortable).

Results and safety

Results posted to the registry on 11 Mar 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Run-In Only	78	67
Durezol	107	103
Vehicle	104	101

Primary outcome: Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks

Time frame: Baseline, up to 4 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Durezol n = 107	Vehicle n = 104
Baseline (Week 0)	78.3 (14.4)	76.8 (13.8)
Change from Baseline to Week 1	-1.1 (8.8)	-1.7 (12.4)
Change from Baseline to Week 2	-4.4 (10.9)	-4.2 (14.7)
Change from Baseline to Week 3	-4.5 (13.4)	-4.8 (16.2)
Change from Baseline to Week 4	-6.2 (15.1)	-4.7 (16.1)

Population analysed: All subjects randomized to treatment and receiving at least 1 administration of study medication (ITT). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.

Adverse events

Time frame: Adverse events were collected for the duration of the study (10 months, 15 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Run-In	0 of 289 (0%)	47 of 289 (16.3%)	Not reported
Durezol	1 of 107 (0.9%)	12 of 107 (11.2%)	Not reported
Vehicle	1 of 104 (1%)	3 of 104 (2.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 Difluprednate 0.05% ophthalmic emulsion in people with Dry Eye Disease, run by Alcon Research 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 11 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 11 Mar 2013. 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. Some participants in this study may receive a placebo. 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 11 Mar 2013). 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?

Mean Change From Baseline (Week 0) in Visual Analog Scale (VAS) Global Ocular Discomfort Score Over 4 Weeks (time frame: Baseline, up to 4 weeks). 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 NCT01276223.

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 11 Mar 2013.