Dry Eye SyndromesPhase 4NCT00756678

Efficacy and Acceptability of Two Lubricant Eye Drops

A Phase 4 study testing Lubricant Eye Drops (Optive™) and Lubricating Eye Drops (blink® Tears) 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

Efficacy and acceptability of two new artificial tears following two weeks of treatment in patients with dry eye. Patients will be randomized to 1 of 2 treatments for 7 days then crossover to the alternate treatment for 7 days. 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 Syndromes
What is being tested?: Lubricant Eye Drops (Optive™) and Lubricating Eye Drops (blink® Tears)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: Sep 2008to Aug 2009
Phase: Phase 4
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

Male or Female
At least 18 years of age
Current use of artificial tears

Who cannot join

Any uncontrolled systemic disease
Pregnancy or planning a pregnancy
Contact lens wear

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Chevy Chase, Maryland

Other trials in United States

About this study

Conditions: Dry Eye Syndromes
Being tested: Lubricant Eye Drops (Optive™), Lubricating Eye Drops (blink® Tears)
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.

Lubricant Eye Drops (Optive™)Drug
Also called Optive™
1 drop in both eyes as needed for 7 days'
Lubricating Eye Drops (blink® Tears)Drug
Also called blink® Tears
1 drop in both eyes as needed for 7 days

Study groups in NCT00756678
Study group	Role	What they receive
1	Active comparator	Carboxymethylcellulose and Glycerin Receives: Drug: Lubricant Eye Drops (Optive™)
2	Active comparator	Polyethylene glycol 400 Receives: Drug: Lubricating Eye Drops (blink® Tears)

What is being measured

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

Mean Frequency of Eye Drop Use Over 1 Week
Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.
Measured: 1 week

Secondary outcomes (3)

Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16
Mean change from baseline in Dry Eye Disease Comfort Assessment Score at Day 16. The Dry Eye Disease Comfort Assessment consists of one question asking the patient to rate their current overall discomfort from their dry eye symptoms on a scale of 0 to 10 (0 equals No Discomfort; 10 equals Intolerable). The greater the negative number change from baseline, the greater the improvement in comfort.
Measured: Baseline, Day 16
Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16
Percentage of patients who responded "Strongly Agree" and "Agree" to Subject Acceptability Questionnaire Question 1: Overall Liked. The Subject Acceptability Questionnaire consists of 11 multiple choice questions assessing how the patients feel about the eye drops received. The 5 possible responses to the questionnaire are "Strongly Agree", "Agree", "Neither Agree or Disagree", "Disagree" and "Strongly Disagree".
Measured: Day 16
Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16
Number of patients who marked that either Week 1 study product was more soothing or Week 2 study product was more soothing to the Overall Comfort Preference Questionnaire on Day 16 of the cross-over period. The Subject Preference Questionnaire consists of 4 questions related to comfort, soothing, blurring and purchase preference comparing treatments received during Week 1 versus Week 2.
Measured: Day 16

Timeline

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

Sep 2008Aug 2009

First posted22 Sep 2008 (estimated)
Study startSep 2008
Primary completionAug 2009
Study completionAug 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00756678
Sponsor's protocol ID: MA-OPT-08-001
Status last verified: Sep 2011
First submitted: 18 Sep 2008
Last updated: 31 Oct 2011
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?

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Acceptability of Two Lubricant Eye Drops
ClinicalTrials.gov ID: NCT00756678
Acronym / sponsor ID: MA-OPT-08-001
Conditions: Dry Eye Syndromes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 22 Sep 2008 (estimated)
Results: Posted 31 Oct 2011

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Lubricant Eye Drops (Optive™)Carboxymethylcellulose and Glycerin
2	Active comparator	Drug: Lubricating Eye Drops (blink® Tears)Polyethylene glycol 400

Who may qualify

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

Key inclusion criteria (3 listed)

Male or Female
At least 18 years of age
Current use of artificial tears

Key exclusion criteria (3 listed)

Any uncontrolled systemic disease
Pregnancy or planning a pregnancy
Contact lens wear

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
Lubricant Eye Drops (Optive™)Also: Optive™1 drop in both eyes as needed for 7 days'	Drug	1
Lubricating Eye Drops (blink® Tears)Also: blink® Tears1 drop in both eyes as needed for 7 days	Drug	2

Primary outcome

Mean Frequency of Eye Drop Use Over 1 Week
Time frame: 1 week
Mean frequency of eye drop use per day per patient during the cross-over period over 1 week. Eye drop use was captured on a daily tear diary that the patients completed. The greater the frequency of use, the more eye drops were required to manage the patient's dry eye symptoms.

3 secondary outcomes

Change From Baseline in Dry Eye Disease Comfort Assessment Score on Day 16
Time frame: Baseline, Day 16
Percentage of Positive Patient Responses to Subject Acceptability Questionnaire on Day 16
Time frame: Day 16
Number of Patients With Positive Responses to Subject Preference Questionnaire on Day 16
Time frame: Day 16

Results and safety

Results posted to the registry on 31 Oct 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
All Patients	51	50

Primary outcome: Mean Frequency of Eye Drop Use Over 1 Week

Time frame: 1 week. Mean (Standard Deviation). Unit: Use per day

Measure	Lubricant Eye Drops (Optive™) n = 50	Lubricant Eye Drops (Blink® Tears) n = 50
Value	1.76 (0.89921)	1.66 (0.94459)

Population analysed: Intent to Treat; defined as all randomized (started study) patients. Of the 51 patients that were randomized, data for 50 patients were evaluated for this outcome measure

3 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
All Patients	0 of 51 (0%)	0 of 51 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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 4 study testing Lubricant Eye Drops (Optive™) and Lubricating Eye Drops (blink® Tears) 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 31 Oct 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?

Yes. Results are posted in the registry (first posted 31 Oct 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?

Mean Frequency of Eye Drop Use Over 1 Week (time frame: 1 week). 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 NCT00756678.

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 31 Oct 2011.