GlaucomaPhase 4NCT00966940
Efficacy and Safety of Travoprost 0.004% Versus Tafluprost 0.0015% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension
A Phase 4 study testing Travoprost 0.004% ophthalmic solution (TRAVATAN) and Tafluprost 0.0015% ophthalmic solution in people with Glaucoma, run by Alcon Research.
Trial summary
The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when both medications are administered in the evening. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Travoprost 0.004% ophthalmic solution (TRAVATAN) and Tafluprost 0.0015% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An EC-reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
- Patients must be at least 21 years of age.
- Must be able to follow instructions and be willing and able to attend required study visits.
- Must have a clinical diagnosis of ocular hypertension or primary open-angle glaucoma in at least one eye (qualifying eye).
- Currently treated patients, in the investigator's judgment, should require a change in treatment for reasons of improved efficacy, tolerability or compliance.
- Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
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- Must have an intraocular pressure of > 21 mm Hg in at least one eye at 08:00 and > 19 mm Hg in the same eye at 16:00, and < 35 mm Hg in both eyes at all diurnal time points at Visit 2.
- Must have best corrected visual acuity of 6/60 (20/200 Snellen) or better in each eye.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Presence of other primary or secondary glaucomas not listed in inclusion criterion.
- Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable).
- Any abnormality preventing reliable applanation tonometry in qualifying eye(s).
- Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
- Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
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- Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
- Progressive retinal or optic nerve disease from any cause apart from glaucoma.
- Women of childbearing potential not using reliable means of birth control, or pregnant or lactating females.
- Any clinically significant, serious, or severe medical or psychiatric condition.
- A condition, which in the opinion of the investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient.
- Participation in any other investigational study within 30 days prior to Visit 2.
- Known medical history of allergy or sensitivity to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the investigator.
- 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 Visit 2 or an anticipated change in the dosage during the course of the study.
- Anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
- A history of, or at risk for uveitis or cystoid macular edema (CME).
- History of ocular herpes simplex.
- Unwillingness to accept the risk of iris, skin, or eyelash changes associated with prostaglandin therapy.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: The Efficacy and Safety of Travoprost, 0.004% Versus Tafluprost, 0.0015% in Primary Open-Angle Glaucoma or Ocular Hypertensive Patients
The purpose of this study is to assess the safety and efficacy of Travoprost 0.004% and Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when both medications are administered in the evening.
- Conditions
- Glaucoma
- Being tested
- Travoprost 0.004% ophthalmic solution (TRAVATAN), Tafluprost 0.0015% ophthalmic solution
- Keywords
- Glaucoma, IOP, Travoprost
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Travoprost 0.004% ophthalmic solution (TRAVATAN)Drug
Also called TRAVATAN
One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration
Tafluprost 0.0015% ophthalmic solutionDrug
One drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration
| Study group | Role | What they receive |
|---|---|---|
| Travoprost-to-tafluprost | Other | Travoprost first, with tafluprost second. Each product dosed for six weeks. Receives: Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN); Drug: Tafluprost 0.0015% ophthalmic solution |
| Tafluprost-to-travoprost | Other | Tafluprost first, with travoprost second. Each product dosed for six weeks. Receives: Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN); Drug: Tafluprost 0.0015% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP) at 8:00 PM
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 6 weeks
Secondary outcomes (6)
Mean Intraocular Pressure (IOP) at 8:00 AM
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 6 weeks
Mean Intraocular Pressure (IOP) at 10:00 AM
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 6 weeks
Mean Intraocular Pressure (IOP) at 12:00 PM
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 6 weeks
Mean Intraocular Pressure (IOP) at 2:00 PM
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 6 weeks
Mean Intraocular Pressure (IOP) at 4:00 PM
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 6 weeks
Mean Intraocular Pressure (IOP) at 6:00 PM
Intraocular pressure was measured by Goldmann applanation tonometry.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966940
- Sponsor's protocol ID
- SMA-08-16
- Status last verified
- May 2012
- First submitted
- 26 Aug 2009
- Last updated
- 20 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Travoprost, 0.004% Versus Tafluprost, 0.0015% in Primary Open-Angle Glaucoma or Ocular Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00966940
- Acronym / sponsor ID
- SMA-08-16
- Conditions
- Glaucoma
- Keywords
- Glaucoma, IOP, Travoprost
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 20 Jun 2012
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 assess the safety and efficacy of Travoprost 0.004% and Tafluprost 0.0015% in patients with primary open angle glaucoma or ocular hypertension when both medications are administered in the evening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost-to-tafluprost | Other | Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN), Drug: Tafluprost 0.0015% ophthalmic solutionTravoprost first, with tafluprost second. Each product dosed for six weeks. |
| Tafluprost-to-travoprost | Other | Drug: Travoprost 0.004% ophthalmic solution (TRAVATAN), Drug: Tafluprost 0.0015% ophthalmic solutionTafluprost first, with travoprost second. Each product dosed for six weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- An EC-reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
- Patients must be at least 21 years of age.
- Must be able to follow instructions and be willing and able to attend required study visits.
- Must have a clinical diagnosis of ocular hypertension or primary open-angle glaucoma in at least one eye (qualifying eye).
- Currently treated patients, in the investigator's judgment, should require a change in treatment for reasons of improved efficacy, tolerability or compliance.
Key exclusion criteria (19 listed)
- Presence of other primary or secondary glaucomas not listed in inclusion criterion.
- Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable).
- Any abnormality preventing reliable applanation tonometry in qualifying eye(s).
- Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or 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% ophthalmic solution (TRAVATAN)Also: TRAVATANOne drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration | Drug | Tafluprost-to-travoprost, Travoprost-to-tafluprost |
| Tafluprost 0.0015% ophthalmic solutionOne drop in the qualifying eye(s) each evening at 6:00 PM for 6 weeks, topical administration | Drug | Tafluprost-to-travoprost, Travoprost-to-tafluprost |
Primary outcome
Mean Intraocular Pressure (IOP) at 8:00 PM
Time frame: 6 weeks
Intraocular pressure was measured by Goldmann applanation tonometry.
6 secondary outcomes
Mean Intraocular Pressure (IOP) at 8:00 AM
Time frame: 6 weeks
Mean Intraocular Pressure (IOP) at 10:00 AM
Time frame: 6 weeks
Mean Intraocular Pressure (IOP) at 12:00 PM
Time frame: 6 weeks
Mean Intraocular Pressure (IOP) at 2:00 PM
Time frame: 6 weeks
Mean Intraocular Pressure (IOP) at 4:00 PM
Time frame: 6 weeks
Mean Intraocular Pressure (IOP) at 6:00 PM
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Travoprost 0.004% ophthalmic solution (TRAVATAN) and Tafluprost 0.0015% ophthalmic solution in people with Glaucoma, 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 19 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 20 Jun 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 20 Jun 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 Intraocular Pressure (IOP) at 8:00 PM (time frame: 6 weeks). 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 20 Jun 2012.