Open-Angle GlaucomaPhase 4NCT00527592

A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

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 Open-Angle 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

Search all trials

Trial summary

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Open-Angle 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: 54 participants
Where: No sites listed yet
Study dates: May 2007to Aug 2008
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.
Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
Best corrected visual acuity of 20/200 Snellen or better in each eye.
Intraocular pressure within protocol-specified range.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Any abnormality preventing reliable applanation tonometry in the study eye(s).
Any eye conditions or procedures as specified in protocol.
Progressive retinal or optic nerve disease from any cause.
Use of contact lenses in the study eye(s).
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®), Latanoprost ophthalmic solution 0.005% (XALATAN®)
Keywords: Comfort
Medical subject headings: Glaucoma, Open-Angle, 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®
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.
Latanoprost ophthalmic solution 0.005% (XALATAN®)Drug
Also called XALATAN®
Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.

Study groups in NCT00527592
Study group	Role	What they receive
Travoprost	Experimental	Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned. Receives: Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)
Latanoprost	Active comparator	Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned. 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.

Comfort Immediately After Dosing
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.
Measured: 5 seconds

Timeline

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

May 2007Aug 2008

First posted11 Sep 2007 (estimated)
Study startMay 2007
Primary completionAug 2008
Study completionAug 2008

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 Open-Angle 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: Single group
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00527592
Sponsor's protocol ID: SMA-07-01
Status last verified: May 2012
First submitted: 10 Sep 2007
Last updated: 18 May 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

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

All Open-Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Dose Comfort Comparison of Travatan Z in One Eye Versus Xalatan in the Opposite Eye in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
ClinicalTrials.gov ID: NCT00527592
Acronym / sponsor ID: SMA-07-01
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: Comfort
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 11 Sep 2007 (estimated)
Results: Posted 10 Feb 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to compare the comfort of Travatan Z in one eye and Xalatan in the opposite eye in patients with primary open-angle glaucoma or ocular hypertension.

Study design

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

Arm	Type	Receives
Travoprost	Experimental	Drug: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®)Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.
Latanoprost	Active comparator	Drug: Latanoprost ophthalmic solution 0.005% (XALATAN®)Latanoprost assigned to one eye, with travoprost assigned to the fellow eye for intra-individual control. One drop, single dose. The eye, and the order in which the first test medicine was instilled (either travoprost or latanoprost), was randomly assigned.

Who may qualify

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

Key inclusion criteria (5 listed)

18 years of age or older.
Clinical diagnosis of ocular hypertension, primary open-angle, pigment dispersion, or exfoliation glaucoma in both eyes.
Best corrected visual acuity of 20/200 Snellen or better in each eye.
Intraocular pressure within protocol-specified range.
Other protocol-defined inclusion criteria may apply.

Key exclusion criteria (5 listed)

Any abnormality preventing reliable applanation tonometry in the study eye(s).
Any eye conditions or procedures as specified in protocol.
Progressive retinal or optic nerve disease from any cause.
Use of contact lenses in the study eye(s).
Other protocol-defined exclusion criteria may apply.

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®Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as travoprost.	Drug	Travoprost
Latanoprost ophthalmic solution 0.005% (XALATAN®)Also: XALATAN®Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop, single dose. Referred to as latanoprost.	Drug	Latanoprost

Primary outcome

Comfort Immediately After Dosing
Time frame: 5 seconds
Comfort was assessed by the patient and recorded on a scale of 0 to 100, with 0 = perfect comfort and 100 = worse discomfort imaginable.

Results and safety

Results posted to the registry on 10 Feb 2010, 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/Latanoprost	54	54

Primary outcome: Comfort Immediately After Dosing

Time frame: 5 seconds. Mean (Standard Deviation). Unit: Units on a scale

Measure	Travoprost n = 54	Latanoprost n = 54
Value	7.8 (16.1)	7.1 (16.2)

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

Adverse events

Time frame: Adverse events were collected for the duration of the study and 14 days post study exit.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Travoprost	0 of 54 (0%)	0 of 54 (0%)	Not reported
Latanoprost	0 of 54 (0%)	0 of 54 (0%)	Not reported

Limitations and caveats (from the sponsor): None specified.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Open-Angle Glaucoma

RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma

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.

The record lists no contact. Use the official record to reach the sponsor.

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 5 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 18 May 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 10 Feb 2010). 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?

Comfort Immediately After Dosing (time frame: 5 seconds). 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 NCT00527592.

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 18 May 2012.