GlaucomaPhase 4NCT01464424
Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)
A Phase 4 study testing Travoprost 0.004% ophthalmic solution and Bimatoprost 0.01% ophthalmic solution in people with Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- What is being tested?
- Travoprost 0.004% ophthalmic solution and Bimatoprost 0.01% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Oct 2011to Jun 2012
- 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 open-angle glaucoma (OAG) or ocular hypertension (OHT) in at least one eye.
- Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic therapy or on the study medicine alone.
- Willing to discontinue the use of all other ocular hypotensive medications prior to receiving study medication and for the entire course of the study.
- Able to follow instructions, self instill study article, and attend all study visits.
- Best-corrected Snellen visual acuity of 20/200 or better in each eye.
- Sign 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 the preparations used in this study.
- Any abnormality preventing applanation tonometry in either eye.
- Dry eye previously or currently being treated with punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Intraocular conventional or laser surgery >3 months prior to consent.
- 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.
- Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to Screening or an anticipated change in dosage during the course of the study.
- Any clinically significant, serious, or severe medical condition.
- Women of childbearing potential who are pregnant, lactating, or not using reliable means of birth control.
- Participation in any other study within 30 days prior to Screening.
- Use of any systemic (oral), injectable or topical steroids.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: Assessment of Late Day IOP Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)
The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.
- Conditions
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Being tested
- Travoprost 0.004% ophthalmic solution, Bimatoprost 0.01% ophthalmic solution
- Keywords
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma, Intraocular Pressure
- Medical subject headings
- Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004% ophthalmic solutionDrug
Also called TRAVATAN® Z
Bimatoprost 0.01% ophthalmic solutionDrug
Also called LUMIGAN®
| Study group | Role | What they receive |
|---|---|---|
| TRAVATAN, then LUMIGAN | Other | Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks Receives: Drug: Travoprost 0.004% ophthalmic solution; Drug: Bimatoprost 0.01% ophthalmic solution |
| LUMIGAN, then TRAVATAN | Other | Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks Receives: Drug: Travoprost 0.004% ophthalmic solution; Drug: Bimatoprost 0.01% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Mean Intraocular Pressure (IOP)
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.
Measured: Week 6
Secondary outcomes (1)
Mean IOP at Each After Office Hour Evaluation Timepoint
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.
Measured: Week 6: 4 pm, 6 pm, 8 pm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2012
- Study completionJun 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Doug Hubatsch, MS, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464424
- Sponsor's protocol ID
- RDG-10-003
- Status last verified
- Sep 2013
- First submitted
- 1 Nov 2011
- Last updated
- 13 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
DuBiner HB, Hubatsch DA. Late-day intraocular pressure-lowering efficacy and tolerability of travoprost 0.004% versus bimatoprost 0.01% in patients with open-angle glaucoma or ocular hypertension: a randomized trial. BMC Ophthalmol. 2014 Nov 28;14:151. doi: 10.1186/1471-2415-14-151.
PubMed 25432143
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Late Day IOP Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)
- ClinicalTrials.gov ID
- NCT01464424
- Acronym / sponsor ID
- RDG-10-003
- Conditions
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Keywords
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma, Intraocular Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Nov 2011 (estimated)
- Results
- Posted 4 Sep 2013
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 was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRAVATAN, then LUMIGAN | Other | Drug: Travoprost 0.004% ophthalmic solution, Drug: Bimatoprost 0.01% ophthalmic solutionTravoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks |
| LUMIGAN, then TRAVATAN | Other | Drug: Travoprost 0.004% ophthalmic solution, Drug: Bimatoprost 0.01% ophthalmic solutionBimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 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 open-angle glaucoma (OAG) or ocular hypertension (OHT) in at least one eye.
- Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic therapy or on the study medicine alone.
- Willing to discontinue the use of all other ocular hypotensive medications prior to receiving study medication and for the entire course of the study.
- Able to follow instructions, self instill study article, and attend all study visits.
- Best-corrected Snellen visual acuity of 20/200 or better in each eye.
Key exclusion criteria (13 listed)
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations used in this study.
- Any abnormality preventing applanation tonometry in either eye.
- Dry eye previously or currently being treated with punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
- Intraocular conventional or laser surgery >3 months prior to consent.
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% ophthalmic solutionAlso: TRAVATAN® Z | Drug | LUMIGAN, then TRAVATAN, TRAVATAN, then LUMIGAN |
| Bimatoprost 0.01% ophthalmic solutionAlso: LUMIGAN® | Drug | LUMIGAN, then TRAVATAN, TRAVATAN, then LUMIGAN |
Primary outcome
Overall Mean Intraocular Pressure (IOP)
Time frame: Week 6
IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.
1 secondary outcome
Mean IOP at Each After Office Hour Evaluation Timepoint
Time frame: Week 6: 4 pm, 6 pm, 8 pm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25432143DuBiner HB, Hubatsch DA. Late-day intraocular pressure-lowering efficacy and tolerability of travoprost 0.004% versus bimatoprost 0.01% in patients with open-angle glaucoma or ocular hypertension: a randomized trial. BMC Ophthalmol. 2014 Nov 28;14:151. doi: 10.1186/1471-2415-14-151.
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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.
Doug Hubatsch, MS study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost 0.004% ophthalmic solution and Bimatoprost 0.01% ophthalmic solution 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 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 13 Sep 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?
Yes. Results are posted in the registry (first posted 4 Sep 2013). 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?
Overall Mean Intraocular Pressure (IOP) (time frame: Week 6). 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 NCT01464424, which also lists 1 linked publication.
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 13 Sep 2013.