Dry Eye SyndromeNCT01010282

Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

A study testing Glycerin and Polysorbate 80 based artificial tear, Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear and Formulation 2: Carboxymethylcellulose sodium, 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

This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye. 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?: Glycerin and Polysorbate 80 based artificial tear, Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear and Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 288 participants
Where: 1 siteUnited States
Study dates: Nov 2009to Apr 2010
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

Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
Ability/agreement to wear habitual correction (glasses) during study period

Who cannot join

Known allergy or sensitivity to the study product(s) or its components
Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
Chronic use of systemic medications which may affect a dry eye condition
Active ocular allergy or infection
Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during 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

This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.

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

Glycerin and Polysorbate 80 based artificial tearDrug
Also called Refresh Dry Eye Therapy® Lubricant Eye Drops
1-2 drops in each eye, as needed, but at least twice daily
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tearDrug
1-2 drops in each eye, as needed, but at least twice daily
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tearDrug
1-2 drops in each eye, as needed, but at least twice daily

Study groups in NCT01010282
Study group	Role	What they receive
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
Artificial Tears 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 Tears 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

What is being measured

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

Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.
Measured: Baseline (Day 1), Day 90

Secondary outcomes (4)

Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90
Change from baseline in the OSDI total score at day 90. The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time and 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability and 100=complete disability). A negative number change from baseline represents an improvement.
Measured: Baseline (Day 1), Day 90
Change From Baseline in Tear Break-up Time (TBUT) at Day 90
Change from baseline in TBUT at day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).
Measured: Baseline (Day 1), Day 90
Change From Baseline in Corneal Staining at Day 90
Change from baseline in corneal staining at day 90. The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).
Measured: Baseline (Day 1), Day 90
Change From Baseline in Conjunctival Staining Severity Score at Day 90
Change from baseline in conjunctival staining severity score at day 90. The conjunctiva is the clear membrane covering the white surface of the eye. Conjunctival staining following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=severe staining) over 6 areas of the white part of the eye for a minimum score of 0 and a maximum score of 30. The higher the score, the worse the dry eye condition. A negative number change from baseline represents a decrease in the severity of conjunctival staining (improvement).
Measured: Baseline (Day 1), Day 90

Timeline

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

Nov 2009Apr 2010

First posted10 Nov 2009 (estimated)
Study startNov 2009
Primary completionApr 2010
Study completionApr 2010

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.
Publications (1)Papers the sponsor has linked to this study.
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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 288 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01010282
Sponsor's protocol ID: AG9965-002
Status last verified: Jul 2015
First submitted: 6 Nov 2009
Last updated: 17 Aug 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Simmons PA, Carlisle-Wilcox C, Chen R, Liu H, Vehige JG. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015 Apr 1;37(4):858-68. doi: 10.1016/j.clinthera.2015.01.001. Epub 2015 Feb 4.
PubMed 25659956

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 Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
ClinicalTrials.gov ID: NCT01010282
Acronym / sponsor ID: AG9965-002
Conditions: Dry Eye Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 288 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 10 Nov 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.

This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.

Study design

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

Arm	Type	Receives
Glycerin and Polysorbate 80 based artificial tear	Active comparator	Drug: Glycerin and Polysorbate 80 based artificial tearGlycerin and Polysorbate 80 based artificial tear
Artificial Tears 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 Tears 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

Who may qualify

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

Key inclusion criteria (2 listed)

Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
Ability/agreement to wear habitual correction (glasses) during study period

Key exclusion criteria (6 listed)

Known allergy or sensitivity to the study product(s) or its components
Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
Chronic use of systemic medications which may affect a dry eye condition
Active ocular allergy or infection
Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1

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
Glycerin and Polysorbate 80 based artificial tearAlso: Refresh Dry Eye Therapy® Lubricant Eye Drops1-2 drops in each eye, as needed, but at least twice daily	Drug	Glycerin and Polysorbate 80 based artificial tear
Formulation 1: Carboxymethylcellulose sodium, glycerin and Polysorbate 80, based artificial tear1-2 drops in each eye, as needed, but at least twice daily	Drug	Artificial Tears Formulation 1
Formulation 2: Carboxymethylcellulose sodium, glycerin, and Polysorbate 80 based artificial tear1-2 drops in each eye, as needed, but at least twice daily	Drug	Artificial Tears Formulation 2

Primary outcome

Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
Time frame: Baseline (Day 1), Day 90
Change from baseline in SESoD score at day 90. The SESoD is a 5-point scale where 0 equals no dryness, 1 equals trace dryness, 2 equals mild dryness, 3 equals moderate dryness, and 4 equals severe dryness. A negative number change from baseline indicates a decrease (improvement) in the symptom of dryness.

4 secondary outcomes

Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90
Time frame: Baseline (Day 1), Day 90
Change From Baseline in Tear Break-up Time (TBUT) at Day 90
Time frame: Baseline (Day 1), Day 90
Change From Baseline in Corneal Staining at Day 90
Time frame: Baseline (Day 1), Day 90
Change From Baseline in Conjunctival Staining Severity Score at Day 90
Time frame: Baseline (Day 1), Day 90

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
Artificial Tears Formulation 1	97	91
Artificial Tears Formulation 2	95	88
Glycerin and Polysorbate 80 Based Artificial Tear	96	77

Primary outcome: Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90

Time frame: Baseline (Day 1), Day 90. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Artificial Tears Formulation 1 n = 97	Artificial Tears Formulation 2 n = 95	Glycerin and Polysorbate 80 Based Artificial Tear n = 96
Baseline (Day 1)	2.7 (0.59)	2.8 (0.67)	2.8 (0.65)
Change from Baseline at Day 90	-0.7 (0.89)	-0.7 (0.90)	-0.7 (0.96)

Population analysed: Intent-to-treat, which includes all patients who started the study (randomized).

4 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 Tears Formulation 1	2 of 97 (2.1%)	28 of 97 (28.9%)	Not reported
Artificial Tears Formulation 2	0 of 95 (0%)	14 of 95 (14.7%)	Not reported
Glycerin and Polysorbate 80 Based Artificial Tear	4 of 96 (4.2%)	37 of 96 (38.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25659956Simmons PA, Carlisle-Wilcox C, Chen R, Liu H, Vehige JG. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015 Apr 1;37(4):858-68. doi: 10.1016/j.clinthera.2015.01.001. Epub 2015 Feb 4.

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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 2 inclusion and 6 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 17 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?

Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90 (time frame: Baseline (Day 1), Day 90). 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 NCT01010282, which also lists 1 linked publication.

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 17 Aug 2015.