Dry Eye SyndromesPhase 3NCT01294384

Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease

A Phase 3 study testing carboxymethylcellulose sodium based New Eye Drop Formulation 1, carboxymethylcellulose sodium based New Eye Drop Formulation 2 and carboxymethylcellulose sodium based Eye Drops in people with Dry Eye Syndromes, run by Allergan at 2 sites in 2 countries.

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 investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: carboxymethylcellulose sodium based New Eye Drop Formulation 1, carboxymethylcellulose sodium based New Eye Drop Formulation 2 and carboxymethylcellulose sodium based Eye Drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 305 participants
Where: 2 sitesin 2 countries
Study dates: 1 May 2011to 25 Sep 2012
Phase: Phase 3
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 product at least twice daily for at least 3 months, on average
Ability/agreement to continue wearing existing spectacle correction (glasses) during study

Who cannot join

Anticipated contact lens wear during study or contact lens use within 6 months
Active ocular infection or allergy
Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
Use of any topical cyclosporine products within 3 months

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Australia1 site

Study site
Randwick, New South Wales

Other trials in Australia

Canada1 site

Study site
St. John's, Newfoundland and Labrador

Other trials in Canada

About this study

This study will investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Conditions: Dry Eye Syndromes
Being tested: carboxymethylcellulose sodium based New Eye Drop Formulation 1, carboxymethylcellulose sodium based New Eye Drop Formulation 2, carboxymethylcellulose sodium based Eye Drops
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.

carboxymethylcellulose sodium based New Eye Drop Formulation 1Drug
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
carboxymethylcellulose sodium based New Eye Drop Formulation 2Drug
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
carboxymethylcellulose sodium based Eye DropsDrug
Also called Refresh Tears®
1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

Study groups in NCT01294384
Study group	Role	What they receive
New Eye Drop Formulation 1	Experimental	1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days. Receives: Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 1
New Eye Drop Formulation 2	Experimental	1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days. Receives: Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 2
Refresh Tears®	Active comparator	1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days. Receives: Drug: carboxymethylcellulose sodium based Eye Drops

What is being measured

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

Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.
Measured: Baseline, Day 90

Secondary outcomes (7)

Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness
The participant rated the severity of their dry eye symptom: dryness using a VAS scale. Participants put a mark on a 100 millimeter line where 0 (far left on the line)=no symptoms to 100 (far right on the line)=most severe symptoms.
Measured: Baseline, Day 90
Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)
Near Visual Acuity was determined using the number of letters read correctly on a low contrast eye chart (gray letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Measured: Baseline, Day 90
Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)
Near Visual Acuity was determined using the number of letters read correctly on a high contrast eye chart (black letters on a white background). An increase in the number of letters read correctly indicated improvement. Much Better is defined as an increase of 10 or more letters read correctly at Day 90 compared to the worse eye at Baseline. Better is defined as an increase of 5 to 9 letters read correctly at Day 90 compared to the worse eye at Baseline.
Measured: Baseline, Day 90
Change From Baseline in Tear Break-Up Time (TBUT)
TBUT is defined as the time (seconds) 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 positive number change from Baseline indicated improvement.
Measured: Baseline, Day 90
Change From Baseline in Corneal Staining
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 where 0=no staining to 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 represented a decrease in corneal staining (improvement).
Measured: Baseline, Day 90
Change From Baseline in Conjunctival Staining
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 where 0=no staining to 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 represented a decrease in the severity of conjunctival staining (improvement).
Measured: Baseline, Day 90
Change From Baseline in Schirmer Test
The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye where Normal=greater than or equal to 10 millimeters (mm) of tears and Dry Eye=less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicated an increase in tears (improvement).
Measured: Baseline, Day 90

Timeline

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

1 May 201125 Sep 2012

First posted11 Feb 2011 (estimated)
Study start1 May 2011
Primary completion25 Sep 2012
Study completion25 Sep 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.
Publications (1)Papers the sponsor has linked to this study.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01294384
Sponsor's protocol ID: 10078X-001
Status last verified: Apr 2019
First submitted: 10 Feb 2011
Last updated: 16 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Simmons PA, Liu H, Carlisle-Wilcox C, Vehige JG. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial. Clin Ophthalmol. 2015 Apr 15;9:665-75. doi: 10.2147/OPTH.S78184. eCollection 2015.
PubMed 25931807

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 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Study of New Eye Drop Formulations With Refresh Tears® in Patients With Dry Eye Disease
ClinicalTrials.gov ID: NCT01294384
Acronym / sponsor ID: 10078X-001
Conditions: Dry Eye Syndromes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 305 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: 1 May 2011 (actual)
Primary completion: 25 Sep 2012 (actual)
Study completion: 25 Sep 2012 (actual)
First posted: 11 Feb 2011 (estimated)
Results: Posted 25 Nov 2013

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 investigate the safety, efficacy and acceptability of two new eye drop formulations compared with Refresh Tears® in patients with dry eye disease.

Study design

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

Arm	Type	Receives
New Eye Drop Formulation 1	Experimental	Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 11 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
New Eye Drop Formulation 2	Experimental	Drug: carboxymethylcellulose sodium based New Eye Drop Formulation 21 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
Refresh Tears®	Active comparator	Drug: carboxymethylcellulose sodium based Eye Drops1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.

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 product at least twice daily for at least 3 months, on average
Ability/agreement to continue wearing existing spectacle correction (glasses) during study

Key exclusion criteria (4 listed)

Anticipated contact lens wear during study or contact lens use within 6 months
Active ocular infection or allergy
Use of any topical ophthalmic medications (eg, topical ophthalmic steroids, glaucoma drops) within 2 weeks
Use of any topical cyclosporine products within 3 months

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
carboxymethylcellulose sodium based New Eye Drop Formulation 11 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.	Drug	New Eye Drop Formulation 1
carboxymethylcellulose sodium based New Eye Drop Formulation 21 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.	Drug	New Eye Drop Formulation 2
carboxymethylcellulose sodium based Eye DropsAlso: Refresh Tears®1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.	Drug	Refresh Tears®

Primary outcome

Change From Baseline in Ocular Surface Disease Index© (OSDI) Score
Time frame: Baseline, Day 90
The OSDI is a questionnaire consisting of 12 questions assessing severity of dry eye using a 5-point scale where 0=none of the time to 4=all of the time. The total score is the sum of the individual scores normalized (standardized) to a severity scale of 0=no symptoms (best score) to 100=maximum severity (worst score). A negative change from Baseline indicated improvement.

7 secondary outcomes

Change From Baseline in Visual Analog (VAS) Symptom Scale: Dryness
Time frame: Baseline, Day 90
Percentage of Participants Much Better or Better in Near Visual Acuity (Low Contrast)
Time frame: Baseline, Day 90
Percentage of Participants Much Better or Better in Near Visual Acuity (High Contrast)
Time frame: Baseline, Day 90
Change From Baseline in Tear Break-Up Time (TBUT)
Time frame: Baseline, Day 90
Change From Baseline in Corneal Staining
Time frame: Baseline, Day 90
Change From Baseline in Conjunctival Staining
Time frame: Baseline, Day 90
Change From Baseline in Schirmer Test
Time frame: Baseline, Day 90

Results and safety

Results posted to the registry on 25 Nov 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
New Eye Drop Formulation 1	101	97
New Eye Drop Formulation 2	100	94
Refresh Tears®	104	95

Primary outcome: Change From Baseline in Ocular Surface Disease Index© (OSDI) Score

Time frame: Baseline, Day 90. Mean (Standard Deviation). Unit: Score on a scale

Measure	New Eye Drop Formulation 1 n = 101	New Eye Drop Formulation 2 n = 100	Refresh Tears® n = 104
Baseline	36.83 (13.350)	38.51 (12.512)	38.86 (11.880)
Change from Baseline at Day 90	-14.72 (16.319)	-12.75 (17.612)	-14.49 (16.443)

Population analysed: Participants from the Intent-to-Treat population, that included all randomized participants.

7 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
New Eye Drop Formulation 1	2 of 102 (2%)	0 of 102 (0%)	Not reported
New Eye Drop Formulation 2	2 of 101 (2%)	0 of 101 (0%)	Not reported
Refresh Tears®	1 of 103 (1%)	0 of 103 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25931807Simmons PA, Liu H, Carlisle-Wilcox C, Vehige JG. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial. Clin Ophthalmol. 2015 Apr 15;9:665-75. doi: 10.2147/OPTH.S78184. eCollection 2015.

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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

2 sites in 2 countries: 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 4 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 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 25 Nov 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?

Change From Baseline in Ocular Surface Disease Index© (OSDI) Score (time frame: Baseline, 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 NCT01294384, 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 16 Apr 2019.