Dry Eye DiseasePhase 3NCT01664949

A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

A Phase 3 study testing Carboxymethylcellulose Based Eye Drop Formulation A and Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops in people with Dry Eye Disease, run by Allergan at 12 sites in 8 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 evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects 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 Disease
What is being tested?: Carboxymethylcellulose Based Eye Drop Formulation A and Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 460 participants
Where: 12 sitesin 8 countries
Study dates: Jan 2013to May 2014
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

Have used artificial tears for dry eye

Who cannot join

Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
History of eye surgery or trauma in the 6 months prior to study start
Current use or use within 2 weeks of study start, of topical eye medications.

Trial locations and contacts

12 sites in 8 countries.

Country

City, postcode or hospital

12 sites in 8 countries

France2 sites

Study site
Marseille
Study site
Tours

Other trials in France

Italy2 sites

Study site
Padova
Study site
Parma

Other trials in Italy

Spain2 sites

Study site
Huelva
Study site
Valencia

Other trials in Spain

United Kingdom2 sites

Study site
Great Yarmouth, Norfolk
Study site
Southampton, Hampshire

Other trials in United Kingdom

Australia1 site

Study site
Randwick, New South Wales

Other trials in Australia

Belgium1 site

Study site
Leuven

Other trials in Belgium

Germany1 site

Study site
Freiburg im Breisgau

Other trials in Germany

Russia1 site

Study site
Moscow

Other trials in Russia

About this study

Conditions: Dry Eye Disease
Being tested: Carboxymethylcellulose Based Eye Drop Formulation A, Carboxymethylcellulose Based Preservative-Free Lubricant 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 Based Eye Drop Formulation ADrug
Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsDrug
Also called REFRESH OPTIVE™, OPTAVA™
Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Study groups in NCT01664949
Study group	Role	What they receive
Carboxymethylcellulose Based Eye Drop Formulation A	Experimental	Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days. Receives: Drug: Carboxymethylcellulose Based Eye Drop Formulation A
OPTIVE™	Active comparator	Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days. Receives: Drug: Carboxymethylcellulose Based Preservative-Free Lubricant 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 at Day 90
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.
Measured: Baseline, Day 90

Secondary outcomes (4)

Change From Baseline in Tear Break-up Time (TBUT)
TBUT is the time in seconds for the tear film to visually break up after a complete blink. The average of 3 consecutive observations is reported for each participant. The longer it takes, the more stable the tear film. The eye with the shorter average TBUT at Baseline was used for analysis. A positive number change from Baseline indicates improvement.
Measured: Baseline, Day 90
Change From Baseline in Corneal Staining
Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.
Measured: Baseline, Day 90
Change From Baseline in Conjunctival Staining
Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). Conjunctival staining has 2 zones, nasal and temporal, which are added together to provide the total staining score. The eye with the higher score at Baseline was used for analysis. The higher the grade score, the worse the dry eye severity. A negative number change from Baseline indicates improvement.
Measured: Baseline, Day 90
Change From Baseline in the Schirmer Test
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye. The eye with the lower value at Baseline was used for Analysis. Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears.. The smaller the number, the more severe the dry eye. A positive number change from Baseline indicates 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.

Jan 2013May 2014

First posted14 Aug 2012 (estimated)
Study startJan 2013
Primary completionMay 2014
Study completionMay 2014

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.
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: 460 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01664949
Sponsor's protocol ID: 11002X-001
Other IDs: 2012-002238-35
Status last verified: Sep 2015
First submitted: 10 Aug 2012
Last updated: 21 Sep 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 Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease
ClinicalTrials.gov ID: NCT01664949
Acronym / sponsor ID: 11002X-001
Conditions: Dry Eye Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 460 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jan 2013
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 14 Aug 2012 (estimated)
Results: Posted 8 Jun 2015

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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Carboxymethylcellulose Based Eye Drop Formulation A	Experimental	Drug: Carboxymethylcellulose Based Eye Drop Formulation ACarboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
OPTIVE™	Active comparator	Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsCarboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times 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 (1 listed)

Have used artificial tears for dry eye

Key exclusion criteria (3 listed)

Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
History of eye surgery or trauma in the 6 months prior to study start
Current use or use within 2 weeks of study start, of topical eye medications.

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 Based Eye Drop Formulation ACarboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.	Drug	Carboxymethylcellulose Based Eye Drop Formulation A
Carboxymethylcellulose Based Preservative-Free Lubricant Eye DropsAlso: REFRESH OPTIVE™, OPTAVA™Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.	Drug	OPTIVE™

Primary outcome

Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90
Time frame: Baseline, Day 90
The OSDI consists of 12 questions to assess visual function, ocular symptoms and environmental triggers related to dry eye. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4 = all of the time) which is converted to a total score between 0-100. OSDI total scores of 0-12=normal (best), 13-22= mild ocular surface disease, 23-32 =moderate ocular surface disease, and 33-100=severe ocular surface disease (worst). A negative number change from Baseline indicates improvement.

4 secondary outcomes

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 the Schirmer Test
Time frame: Baseline, Day 90

Results and safety

Results posted to the registry on 8 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Carboxymethylcellulose Based Eye Drop Formulation A	224	200
OPTIVE™	236	211

Primary outcome: Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Day 90

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

Measure	Carboxymethylcellulose Based Eye Drop Formulation A n = 196	OPTIVE™ n = 198
Baseline	41.77 (14.018)	40.92 (13.310)
Change from Baseline at Day 90 (n=181,185)	-16.88 (17.496)	-15.97 (16.146)

Population analysed: Participants from the Per-protocol population, all randomized participants without any significant protocol violations, with data available for analysis.

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
Carboxymethylcellulose Based Eye Drop Formulation A	5 of 224 (2.2%)	15 of 224 (6.7%)	Not reported
OPTIVE™	4 of 236 (1.7%)	6 of 236 (2.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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

12 sites in 8 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 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 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France, Italy, Spain, United Kingdom, Australia and 3 more countries. 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 8 Jun 2015). 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 at Day 90 (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 NCT01664949.

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 21 Sep 2015.