GlaucomaPhase 4NCT01696383
Assessing the Efficacy of DuoTrav as a Replacement Therapy in Glaucoma Patients in Russia
A Phase 4 study testing Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav) in people with Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure (IOP) is uncontrolled while on their… 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 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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, primary open-angle glaucoma and pseudoexfoliative or pigment dispersion glaucoma.
- Be on a stable IOP-lowering regimen of prostaglandin analogue or beta-blocker (monotherapy) within 4 weeks prior to the Screening Visit.
- Have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Have an IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye). In any eye not designated as a study eye, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
- Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
- Able to follow instructions and willing and able to attend all study visits.
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- Have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- Read, sign, and date an Ethics Committee reviewed and approved informed consent form.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Corneal dystrophies in either eye.
- Any opacity or subject uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- History of ocular herpes simplex infection.
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- Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
- Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause apart from glaucoma.
- Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
- Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
- Unwillingness to risk the possibility of darkened iris or eyelash changes.
- Women of childbearing potential not using reliable means of birth control for at least one month prior to the Screening/Baseline Visit.
- Women who are pregnant or lactating.
- Participation in any other investigational study within 30 days prior to the Screening Visit.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Assessing the Efficacy of DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination), as a Replacement Therapy in Glaucoma Patients in Russia, Previously on Prior Prostaglandin Analogue or Beta-blocker Monotherapy
The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure (IOP) is uncontrolled while on their current treatment.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)
- Keywords
- Intraocular Pressure (IOP), Glaucoma, Ocular hypertension, DuoTrav, Prostaglandin analogue, Beta-blocker
- 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 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)Drug
Also called DuoTrav®
One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| DuoTrav | Experimental | One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks Receives: Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (Day 0) in intraocular pressure (IOP) at final visit (Week 12)
As measured by Goldmann applanation tonometry. If only one eye qualifies for inclusion and treatment, this eye will be selected for analysis. If both eyes qualify and are treated, the worse evaluable eye will be selected for analysis. The worse eye will be the eye with the higher IOP at the screening/baseline visit. If both eyes are equal, the right eye will be selected for analysis.
Measured: Baseline (Day 0), Week 12
Secondary outcomes (1)
Percentage of subjects who reach target IOP (≤18 mmHg)
As measured by Goldmann applanation tonometry.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abayomi Ogundele, PharmD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01696383
- Sponsor's protocol ID
- RDG-11-257
- Status last verified
- Feb 2013
- First submitted
- 27 Sep 2012
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination), as a Replacement Therapy in Glaucoma Patients in Russia, Previously on Prior Prostaglandin Analogue or Beta-blocker Monotherapy
- ClinicalTrials.gov ID
- NCT01696383
- Acronym / sponsor ID
- RDG-11-257
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Intraocular Pressure (IOP), Glaucoma, Ocular hypertension, DuoTrav, Prostaglandin analogue, Beta-blocker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Management decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Oct 2012 (estimated)
- Results
- Not posted in the source record
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 evaluate the efficacy of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure (IOP) is uncontrolled while on their current treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DuoTrav | Experimental | Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)One drop self-administered topically to the study eye(s) once daily every evening at 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 (9 listed)
- Clinical diagnosis of ocular hypertension, primary open-angle glaucoma and pseudoexfoliative or pigment dispersion glaucoma.
- Be on a stable IOP-lowering regimen of prostaglandin analogue or beta-blocker (monotherapy) within 4 weeks prior to the Screening Visit.
- Have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
- Have an IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye). In any eye not designated as a study eye, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
- Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
Key exclusion criteria (17 listed)
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Corneal dystrophies in either eye.
- Any opacity or subject uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
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%/Timolol 0.5% Fixed Combination (DuoTrav)Also: DuoTrav®One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks | Drug | DuoTrav |
Primary outcome
Change from baseline (Day 0) in intraocular pressure (IOP) at final visit (Week 12)
Time frame: Baseline (Day 0), Week 12
As measured by Goldmann applanation tonometry. If only one eye qualifies for inclusion and treatment, this eye will be selected for analysis. If both eyes qualify and are treated, the worse evaluable eye will be selected for analysis. The worse eye will be the eye with the higher IOP at the screening/baseline visit. If both eyes are equal, the right eye will be selected for analysis.
1 secondary outcome
Percentage of subjects who reach target IOP (≤18 mmHg)
Time frame: Week 12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2013.
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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.
Abayomi Ogundele, PharmD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav) in people with 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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 7 Feb 2013. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 (Day 0) in intraocular pressure (IOP) at final visit (Week 12) (time frame: Baseline (Day 0), Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2013.