Open-Angle GlaucomaPhase 4NCT01493427

Efficacy of Changing to TRAVATAN® From Prior Therapy

A Phase 4 study testing Travoprost 0.004% 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

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Trial summary

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy. 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 0.004%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 202 participants
Where: No sites listed yet
Study dates: Dec 2011to Feb 2013
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

Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye
Other protocol-defined inclusion criteria may apply.

Who cannot join

Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
Any clinically significant, serious, or severe medical condition.
Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.

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Progressive retinal or optic nerve disease from any cause.
Women who are pregnant, lactating.
Women not using reliable means of birth control.
Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
Any clinically significant, serious, or severe medical condition.
Participation in any other investigational study within 30 days of Screening Visit.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Multi-Center Study Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (0.004% Travoprost) in Patients Previously on Latanoprost 0.005% or Bimatoprost 0.01% Ophthalmic Solution Monotherapy

Conditions: Open-Angle Glaucoma, Ocular Hypertension
Being tested: Travoprost 0.004%
Keywords: Glaucoma, OAG, OHT
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma

What participants receive

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

Travoprost 0.004%Drug
Also called TRAVATAN® BAK-free
Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative

Study groups in NCT01493427
Study group	Role	What they receive
TRAVATAN® BAK-free	Experimental	Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks Receives: Drug: Travoprost 0.004%

What is being measured

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

Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Measured: Baseline, Week 12

Secondary outcomes (1)

Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Measured: Week 12

Timeline

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

Dec 2011Feb 2013

First posted16 Dec 2011 (estimated)
Study startDec 2011
Primary completionFeb 2013
Study completionFeb 2013

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 202 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01493427
Sponsor's protocol ID: RDG-10-298
Other IDs: 2011-000161-13
Status last verified: May 2014
First submitted: 14 Dec 2011
Last updated: 19 May 2014
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 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center Study Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (0.004% Travoprost) in Patients Previously on Latanoprost 0.005% or Bimatoprost 0.01% Ophthalmic Solution Monotherapy
ClinicalTrials.gov ID: NCT01493427
Acronym / sponsor ID: RDG-10-298
Conditions: Open-Angle Glaucoma, Ocular Hypertension
Keywords: Glaucoma, OAG, OHT
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 202 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 16 Dec 2011 (estimated)
Results: Posted 9 May 2014

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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
TRAVATAN® BAK-free	Experimental	Drug: Travoprost 0.004%Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, 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 (7 listed)

Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period.
Willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.

Key exclusion criteria (13 listed)

Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
Any clinically significant, serious, or severe medical condition.
Intraocular conventional surgery or laser surgery in either eye less than three months prior to Screening Visit.

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 0.004%Also: TRAVATAN® BAK-freeTravoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative	Drug	TRAVATAN® BAK-free

Primary outcome

Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)
Time frame: Baseline, Week 12
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

1 secondary outcome

Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks
Time frame: Week 12

Results and safety

Results posted to the registry on 9 May 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TRAVATAN® BAK-free	199	179

Primary outcome: Mean Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: millimeters mercury (mmHg)

Measure	TRAVATAN® BAK-free n = 187
Baseline	17.0 (3.3)
Change from Baseline at Week 12 (n=178)	-1.16 (2.65)

Population analysed: The Full Analysis Set (FA) included all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit (N=187). Here, "n" is the number of participants with non-missing values at the specific time point.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected and reported in the eCRF at each visit from time of first drug instillation to Week 12. Adverse events were collected for the duration of the study (1 year, 2 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TRAVATAN® BAK-free	4 of 199 (2%)	0 of 199 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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
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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.

Severine Durier, Pharm.D study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Travoprost 0.004% in people with Open-Angle Glaucoma and Ocular Hypertension, run by Alcon Research.

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 7 inclusion and 13 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 19 May 2014. 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 9 May 2014). 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 in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline) (time frame: Baseline, Week 12). 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 NCT01493427.

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 19 May 2014.