Dry Eye SyndromeNCT00932477

Safety and Tolerability of Artificial Tears in Dry Eye Subjects

A study testing Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear, Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear and Glycerin and Polysorbate 80 based artificial tear in people with Dry Eye Syndrome, 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

The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear, Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear and Glycerin and Polysorbate 80 based artificial tear
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: Aug 2009to Sep 2009
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Mild, moderate or severe symptoms of dry eye

Who cannot join

Uncontrolled systemic disease
Contact lens wear
Participation in another clinical study

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
San Diego, California

Other trials in United States

About this study

Conditions: Dry Eye Syndrome
Being tested: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear, Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear, Glycerin and Polysorbate 80 based artificial tear
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.

Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tearDrug
1 to 2 drops into each eye three times per day
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tearDrug
1 to 2 drops into each eye three times per day
Glycerin and Polysorbate 80 based artificial tearDrug
Also called Refresh Dry Eye Therapy®
1 to 2 drops into each eye three times per day

Study groups in NCT00932477
Study group	Role	What they receive
Artificial Tear Formulation 1	Experimental	Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear Receives: Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Artificial Tear Formulation 2	Experimental	Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear Receives: Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Glycerin and Polysorbate 80 based artificial tear	Active comparator	Glycerin and Polysorbate 80 based artificial tear Receives: Drug: Glycerin and Polysorbate 80 based artificial tear

What is being measured

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

Tolerability Questionnaire Mean Scores at 1 Week
Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.
Measured: 1 Week

Secondary outcomes (3)

Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
Number of patients with at least one severity grade increase in biomicroscopy findings at 1 week. Eyes are examined with a special microscope (biomicroscopy), and findings scored using a 5-point scale (0=none, +0.5=trace, +1=mild, +2=moderate, +3=severe). An increase in severity grade indicates worsening.
Measured: 1 Week
Best-Corrected Visual Acuity (BCVA) Status at 1 Week
BCVA status at 1 week reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at 1 week minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more in at least 1 eye; "No Change" equals change between -2 to +2 lines in either eye; "Worse" equals decrease of 2 lines or more in at least 1 eye. BCVA is measured using a special eye chart and is reported as the number of lines (5 letters per line) read correctly.
Measured: 1 Week
The Number of Ophthalmic Adverse Events at 1 Week
The number of ophthalmic adverse events (AE) at 1 week. An ophthalmic AE is any unfavorable and unintended sign, symptom, or disease related to the eye which occurs during the use of the study investigational product
Measured: 1 Week

Timeline

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

Aug 2009Sep 2009

First posted3 Jul 2009 (estimated)
Study startAug 2009
Primary completionSep 2009
Study completionSep 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 SyndromeStudies 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 N/A
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00932477
Sponsor's protocol ID: AG9965-001
Status last verified: Aug 2015
First submitted: 1 Jul 2009
Last updated: 26 Aug 2015
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 Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Tolerability of Artificial Tears in Dry Eye Subjects
ClinicalTrials.gov ID: NCT00932477
Acronym / sponsor ID: AG9965-001
Conditions: Dry Eye Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 3 Jul 2009 (estimated)
Results: Posted 13 Dec 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

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Artificial Tear Formulation 1	Experimental	Drug: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tearFormulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Artificial Tear Formulation 2	Experimental	Drug: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tearFormulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
Glycerin and Polysorbate 80 based artificial tear	Active comparator	Drug: Glycerin and Polysorbate 80 based artificial tearGlycerin and Polysorbate 80 based artificial tear

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Mild, moderate or severe symptoms of dry eye

Key exclusion criteria (3 listed)

Uncontrolled systemic disease
Contact lens wear
Participation in another clinical study

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
Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear1 to 2 drops into each eye three times per day	Drug	Artificial Tear Formulation 1
Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear1 to 2 drops into each eye three times per day	Drug	Artificial Tear Formulation 2
Glycerin and Polysorbate 80 based artificial tearAlso: Refresh Dry Eye Therapy®1 to 2 drops into each eye three times per day	Drug	Glycerin and Polysorbate 80 based artificial tear

Primary outcome

Tolerability Questionnaire Mean Scores at 1 Week
Time frame: 1 Week
Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.

3 secondary outcomes

Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week
Time frame: 1 Week
Best-Corrected Visual Acuity (BCVA) Status at 1 Week
Time frame: 1 Week
The Number of Ophthalmic Adverse Events at 1 Week
Time frame: 1 Week

Results and safety

Results posted to the registry on 13 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
Sequence ABC	7	7
Sequence ACB	8	8
Sequence BAC	9	9
Sequence BCA	7	7
Sequence CAB	8	8
Sequence CBA	8	8

Primary outcome: Tolerability Questionnaire Mean Scores at 1 Week

Time frame: 1 Week. Mean (Standard Deviation). Unit: Scores on a scale

Measure	Artificial Tear Formulation 1 n = 47	Artificial Tear Formulation 2 n = 47	Glycerin and Polysorbate 80 Based Artificial Tear n = 47
How comfortable is drop in the eye?	70.1 (30.01)	70.7 (26.63)	57.3 (31.40)
How soothing is drop in the eye?	65.1 (31.67)	65.9 (27.68)	53.4 (32.63)
How moistening/lubricating is drop in the eye?	68.0 (27.79)	65.9 (28.41)	57.4 (31.51)
How clear is vision with drop in the eye?	66.0 (30.91)	61.1 (30.78)	53.0 (30.87)
How much stickiness with drop in the eye?	24.6 (29.44)	19.5 (23.82)	31.4 (29.03)
How much blur with drop in the eye?	33.2 (29.88)	32.4 (30.52)	48.9 (30.83)
How much burning/stinging with drop in the eye?	14.8 (22.48)	14.3 (22.40)	27.9 (30.62)
How much discomfort with drop in the eye?	19.3 (24.84)	18.9 (26.27)	27.1 (28.57)

Population analysed: Safety population, which consisted of all patients who started the study (randomized) and received treatment.

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
Artificial Tear Formulation 1	0 of 47 (0%)	0 of 47 (0%)	Not reported
Artificial Tear Formulation 2	0 of 47 (0%)	0 of 47 (0%)	Not reported
Glycerin and Polysorbate 80 Based Artificial Tear	0 of 47 (0%)	0 of 47 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2015.
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?

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 1 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 26 Aug 2015. 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 13 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?

Tolerability Questionnaire Mean Scores at 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 NCT00932477.

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 26 Aug 2015.