GlaucomaPhase 4NCT00708422

Effects of Travatan Z and Xalatan on Ocular Surface Health

A Phase 4 study testing Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) and Latanoprost ophthalmic solution 0.005% (XALATAN®) in people with Glaucoma and Ocular Hypertension, run by Alcon Research.

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

The purpose of this randomized, double-masked, parallel-group, multicenter study is to evaluate ocular surface effects after the administration of travoprost with SofZia® preservative system or Xalatan once daily for 12 weeks. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Ocular Hypertension
What is being tested?: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) and Latanoprost ophthalmic solution 0.005% (XALATAN®)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 231 participants
Where: No sites listed yet
Study dates: Jul 2008to Aug 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

18 years of age or older.
Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
IOP controllable and stable on the study medication alone (both eyes).
Believed to have ocular surface disease (OSD).
Tear Break-up Time (TBUT) of ≤ 6 seconds in the study eye.
Willing and able to discontinue the use of any topical ocular medication other than the study medication or BAK free artificial tears for the duration of the study.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
Current use of punctual plugs.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Suspected or diagnosed with Sjogrens's syndrome.
Current use of any brand of artificial tears containing BAK.

Show all 11Show fewer

Use of any systemic medications on a chronic basis not on a stable dosing regimen for at least 30 days prior to Visit 1, or an anticipated change in dosing regimen of medications during the course of the study.
Intraocular conventional surgery or laser surgery in study eyes less than six months prior to Visit 1.
Current use of contact lenses within 30 days of Visit 1.
Participation in any other investigational study within 30 days prior to Visit 1.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and Xalatan®

Conditions: Glaucoma, Ocular Hypertension
Being tested: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®), Latanoprost ophthalmic solution 0.005% (XALATAN®)
Keywords: Ocular surface health, OSDI, TFBUT, Glaucoma, Ocular hypertension, Corneal staining
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

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

Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)Drug
Also called TRAVATAN Z®, travoprost
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.
Latanoprost ophthalmic solution 0.005% (XALATAN®)Drug
Also called XALATAN®, latanoprost
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.

Study groups in NCT00708422
Study group	Role	What they receive
Travoprost	Experimental	One drop self-administered in the study eye(s) once daily at night for 12 weeks Receives: Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Latanoprost	Active comparator	One drop self-administered in the study eye(s) once daily at night for 12 weeks Receives: Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)

What is being measured

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

Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.
Measured: 12 weeks (Day 84)

Secondary outcomes (1)

Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
The OSDI is a 12-question validated questionnaire (resultant overall 0-100 score) used to measure ocular symptoms, visual function, and environmental factors that may affect a patient's vision, where 0 = normal and 100 = severe. The OSDI questionnaire was administered at both visits and completed by the patient with no assistance from the office staff, physician, or anyone else. The baseline OSDI score was subtracted from the 12-week OSDI score and reported as change. A negative number represents a perceived improvement in ocular health.
Measured: 12 weeks (Day 84)

Timeline

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

Jul 2008Aug 2009

First posted2 Jul 2008 (estimated)
Study startJul 2008
Primary completionAug 2009
Study completionAug 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 GlaucomaStudies of the same condition, open and under way.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00708422
Sponsor's protocol ID: SMA-08-07
Status last verified: Mar 2012
First submitted: 30 Jun 2008
Last updated: 23 Apr 2012
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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of Ocular Surface Effects With Administration of TRAVATAN Z® and Xalatan®
ClinicalTrials.gov ID: NCT00708422
Acronym / sponsor ID: SMA-08-07
Conditions: Glaucoma, Ocular Hypertension
Keywords: Ocular surface health, OSDI, TFBUT, Glaucoma, Ocular hypertension, Corneal staining
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 231 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 2 Jul 2008 (estimated)
Results: Posted 23 Apr 2012

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: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Travoprost	Experimental	Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)One drop self-administered in the study eye(s) once daily at night for 12 weeks
Latanoprost	Active comparator	Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)One drop self-administered in the study eye(s) once daily at night for 12 weeks

Who may qualify

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

Key inclusion criteria (8 listed)

18 years of age or older.
Diagnosis of primary open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion) or ocular hypertension in at least one eye (study eye).
Use of BAK (benzalkonium chloride) containing intraocular pressure (IOP) lowering medication for a minimum of one year, including latanoprost (Xalatan®) monotherapy for at least 6 months prior to Visit 1.
IOP controllable and stable on the study medication alone (both eyes).
Believed to have ocular surface disease (OSD).

Key exclusion criteria (11 listed)

Current use or use within the last 3 months of cyclosporine ophthalmic emulsion 0.05% (Restasis®), topical ocular steroids, or topical ocular non-steroidal anti-inflammatory drugs.
Current use of punctual plugs.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Suspected or diagnosed with Sjogrens's syndrome.

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
Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)Also: TRAVATAN Z®, travoprostOphthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as travoprost.	Drug	Travoprost
Latanoprost ophthalmic solution 0.005% (XALATAN®)Also: XALATAN®, latanoprostOphthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 12 weeks (84 days). Referred to as latanoprost.	Drug	Latanoprost

Primary outcome

Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)
Time frame: 12 weeks (Day 84)
Tear film break-up time was assessed by the same examiner both visits using the same slitlamp/settings. Examiner instilled fluorescein onto the patient's eye, after which the patient blinked several times, then kept the eye open. Immediately thereafter, the examiner used a stopwatch to time the occurrence of the first break in the fluorescein film. Three consecutive measurements were taken and averaged for actual TBUT. TBUT at Baseline (Day 0) was subtracted from TBUT at 12 weeks (Day 84) and reported as change. A higher number represents a lengthening in the tear film break up time.

1 secondary outcome

Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Ocular Surface Disease Index (OSDI) Score
Time frame: 12 weeks (Day 84)

Results and safety

Results posted to the registry on 23 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Travoprost	116	112
Latanoprost	115	114

Primary outcome: Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT)

Time frame: 12 weeks (Day 84). Mean (Standard Deviation). Unit: seconds

Measure	Travoprost n = 112	Latanoprost n = 113
Value	0.8 (1.5)	1.1 (2.7)

Population analysed: Intent-to-treat: All patients who received test article and completed the trial.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study: 11 July 2008 through 03 August 2009.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Travoprost	1 of 116 (0.9%)	0 of 116 (0%)	Not reported
Latanoprost	1 of 115 (0.9%)	0 of 115 (0%)	Not reported

Limitations and caveats (from the sponsor): The subjective nature of the OSDI may not be sensitive enough to detect the effects of preservatives on the corneal surface. The measurement and quantification of OSD remains a considerable clinical challenge (Pflugfelder and Baudoin, 2011).

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
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.

Judy Vittitoe, RN, MPH study director

Alcon Research

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 8 inclusion and 11 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

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 23 Apr 2012). 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?

Mean Change at 12 Weeks (Day 84) From Baseline (Day 0) in Tear Film Break Up Time (TBUT) (time frame: 12 weeks (Day 84)). 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 NCT00708422.

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 23 Apr 2012.