Dry Eye SyndromesPhase 4NCT00987727

Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

A Phase 4 study testing carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD) and sodium hyaluronate 0.18% (VISMED® Multi) in people with Dry Eye Syndromes and Keratoconjunctivitis Sicca, run by Allergan at 1 site in France.

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 OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes, Keratoconjunctivitis Sicca
What is being tested?: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD) and sodium hyaluronate 0.18% (VISMED® Multi)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 82 participants
Where: 1 siteFrance
Study dates: Nov 2009to Sep 2010
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
No healthy volunteers
Adult, Older adult

Who may be able to join

Have been using artificial tears for at least 3 months prior to study inclusion
Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
Having moderate to severe symptoms suggestive of dry eye

Who cannot join

Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
Moderate to severe blepharitis
History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
History or active signs of ocular allergic disease or ocular herpes within the last year
History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.

Trial locations and contacts

1 site in 1 country.

France1 site

Study site
Paris

Other trials in France

About this study

This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.

Conditions: Dry Eye Syndromes, Keratoconjunctivitis Sicca
Being tested: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD), sodium hyaluronate 0.18% (VISMED® Multi)
Medical subject headings: Dry Eye Syndromes, Keratoconjunctivitis Sicca

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)Drug
Also called OPTIVE® MD
One drop in each eye three to six times daily, as needed
sodium hyaluronate 0.18% (VISMED® Multi)Drug
Also called VISMED® Multi
One drop in each eye three to six times daily, as needed

Study groups in NCT00987727
Study group	Role	What they receive
1	Experimental	carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) Receives: Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
2	Active comparator	sodium hyaluronate 0.18% (VISMED® Multi) Receives: Drug: sodium hyaluronate 0.18% (VISMED® Multi)

What is being measured

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

Change From Baseline in Global Ocular Staining Score at Day 35
Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).
Measured: Baseline, Day 35

Secondary outcomes (1)

Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.
Measured: Baseline, Day 35

Timeline

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

Nov 2009Sep 2010

First posted1 Oct 2009 (estimated)
Study startNov 2009
Primary completionJul 2010
Study completionSep 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.
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: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 82 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00987727
Sponsor's protocol ID: MAF-AGN-OPH-DE-011
Status last verified: Aug 2011
First submitted: 29 Sep 2009
Last updated: 21 Sep 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?

See locations

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
ClinicalTrials.gov ID: NCT00987727
Acronym / sponsor ID: MAF-AGN-OPH-DE-011
Conditions: Dry Eye Syndromes, Keratoconjunctivitis Sicca
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 82 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jul 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 1 Oct 2009 (estimated)
Results: Posted 21 Sep 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 and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.

Study design

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

Arm	Type	Receives
1	Experimental	Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
2	Active comparator	Drug: sodium hyaluronate 0.18% (VISMED® Multi)sodium hyaluronate 0.18% (VISMED® Multi)

Who may qualify

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

Key inclusion criteria (3 listed)

Have been using artificial tears for at least 3 months prior to study inclusion
Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
Having moderate to severe symptoms suggestive of dry eye

Key exclusion criteria (5 listed)

Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
Moderate to severe blepharitis
History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
History or active signs of ocular allergic disease or ocular herpes within the last year
History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.

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 0.5% , glycerin 0.9% (OPTIVE® MD)Also: OPTIVE® MDOne drop in each eye three to six times daily, as needed	Drug	1
sodium hyaluronate 0.18% (VISMED® Multi)Also: VISMED® MultiOne drop in each eye three to six times daily, as needed	Drug	2

Primary outcome

Change From Baseline in Global Ocular Staining Score at Day 35
Time frame: Baseline, Day 35
Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).

1 secondary outcome

Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
Time frame: Baseline, Day 35

Results and safety

Results posted to the registry on 21 Sep 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
Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	41	36
Sodium Hyaluronate 0.18% (VISMED® Multi)	41	34

Primary outcome: Change From Baseline in Global Ocular Staining Score at Day 35

Time frame: Baseline, Day 35. Mean (Standard Deviation). Unit: Number on a scale (score)

Measure	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) n = 37	Sodium Hyaluronate 0.18% (VISMED® Multi) n = 29
Baseline	5.4 (1.59)	5.9 (1.47)
Day 35	-1.8 (1.95)	-1.8 (2.30)

Population analysed: Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.

1 secondary outcome is 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 0.5% and Glycerin 0.9% (OPTIVE® MD)	1 of 41 (2.4%)	0 of 41 (0%)	Not reported
Sodium Hyaluronate 0.18% (VISMED® Multi)	1 of 38 (2.6%)	0 of 38 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

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

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 5 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 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 France. 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 21 Sep 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 Global Ocular Staining Score at Day 35 (time frame: Baseline, Day 35). 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 NCT00987727.

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 2011.