Dry Eye SyndromesPhase 4NCT00938704

Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

A Phase 4 study testing carboxymethylcellulose 0.5% +glycerin 0.9% and sodium hyaluronate 0.18% in people with Dry Eye Syndromes, run by Allergan at 1 site in Germany.

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

To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of 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 0.5% +glycerin 0.9% and sodium hyaluronate 0.18%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 71 participants
Where: 1 siteGermany
Study dates: Jun 2009to Jun 2009
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

Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
Be likely to complete the entire course of study and to comply with appropriate instructions

Who cannot join

Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
Have uncontrolled systemic disease
Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
Have anticipated contact lens wear during the study
Have an active ocular infection

Trial locations and contacts

1 site in 1 country.

Germany1 site

Study site
Ulm

Other trials in Germany

About this study

Conditions: Dry Eye Syndromes
Being tested: carboxymethylcellulose 0.5% +glycerin 0.9%, sodium hyaluronate 0.18%
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 0.5% +glycerin 0.9%Drug
Also called Optive™ Sensitive
To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
sodium hyaluronate 0.18%Drug
Also called Vismed®
To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

Study groups in NCT00938704
Study group	Role	What they receive
1	Active comparator	carboxymethylcellulose 0.5%, glycerin 0.9% Receives: Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
2	Active comparator	sodium hyaluronate 0.18% Receives: Drug: sodium hyaluronate 0.18%

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) at Week 2
Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.
Measured: Baseline, Week 2

Secondary outcomes (4)

Change From Baseline in Tear Breakup Time (TBUT) at Week 2
Change from baseline in TBUT at Week 2. TBUT is defined as 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 positive number change from baseline indicates improvement.
Measured: Baseline, Week 2
Change From Baseline in Corneal Staining at Week 2
Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Measured: Baseline, Week 2
Change From Baseline in Conjunctival Staining (Temporal) at Week 2
Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Measured: Baseline, Week 2
Change From Baseline in Conjunctival Staining (Nasal) at Week 2
Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Measured: Baseline, Week 2

Timeline

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

Jun 2009Jun 2009

First posted14 Jul 2009 (estimated)
Study startJun 2009
Primary completionJun 2009
Study completionJun 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 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00938704
Sponsor's protocol ID: MA-OPT-09-002
Status last verified: Sep 2011
First submitted: 10 Jul 2009
Last updated: 31 Oct 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?

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All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
ClinicalTrials.gov ID: NCT00938704
Acronym / sponsor ID: MA-OPT-09-002
Conditions: Dry Eye Syndromes
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Jun 2009
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 14 Jul 2009 (estimated)
Results: Posted 31 Oct 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

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

Arm	Type	Receives
1	Active comparator	Drug: carboxymethylcellulose 0.5% +glycerin 0.9%carboxymethylcellulose 0.5%, glycerin 0.9%
2	Active comparator	Drug: sodium hyaluronate 0.18%sodium hyaluronate 0.18%

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 2 times per day (e.g. for relief of dry eye symptoms of dryness).
Be likely to complete the entire course of study and to comply with appropriate instructions

Key exclusion criteria (5 listed)

Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
Have uncontrolled systemic disease
Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
Have anticipated contact lens wear during the study
Have an active ocular infection

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%Also: Optive™ SensitiveTo open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.	Drug	1
sodium hyaluronate 0.18%Also: Vismed®To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.	Drug	2

Primary outcome

Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
Time frame: Baseline, Week 2
Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.

4 secondary outcomes

Change From Baseline in Tear Breakup Time (TBUT) at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Corneal Staining at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Conjunctival Staining (Temporal) at Week 2
Time frame: Baseline, Week 2
Change From Baseline in Conjunctival Staining (Nasal) at Week 2
Time frame: Baseline, Week 2

Results and safety

Results posted to the registry on 31 Oct 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%, Glycerin 0.9%	33	33
Sodium Hyaluronate 0.18%	37	37

Primary outcome: Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2

Time frame: Baseline, Week 2. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Carboxymethylcellulose 0.5%, Glycerin 0.9% n = 33	Sodium Hyaluronate 0.18% n = 37
Baseline	56.06 (13.43)	54.292 (13.100)
Week 2	-27.048 (17.87)	-28.303 (21.821)

Population analysed: Intent-to-Treat (ITT). The ITT population consisted of 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
Carboxymethylcellulose 0.5%, Glycerin 0.9%	0 of 33 (0%)	0 of 33 (0%)	Not reported
Sodium Hyaluronate 0.18%	0 of 37 (0%)	0 of 37 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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?

A Phase 4 study testing carboxymethylcellulose 0.5% +glycerin 0.9% and sodium hyaluronate 0.18% in people with Dry Eye Syndromes, run by Allergan at 1 site in Germany.

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 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 31 Oct 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 Germany. 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 31 Oct 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 Ocular Surface Disease Index (OSDI) at Week 2 (time frame: Baseline, Week 2). 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 NCT00938704.

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 31 Oct 2011.