Open Angle GlaucomaPhase 3NCT00892762
Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health
A Phase 3 study testing Travoprost APS 40 micrograms/ml eye drop solution and Latanoprost 50 micrograms/ml eye drop solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
The purpose of this study is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with 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 APS 40 micrograms/ml eye drop solution and Latanoprost 50 micrograms/ml eye drop solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 434 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to May 2011
- Phase
- Phase 3
- 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
- Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye.
- Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
- Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit 1.
- Women of childbearing potential must meet all of the following conditions at Visit 1:
- They are not breast-feeding.
- They have a negative urine pregnancy test at Visit 1.
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- They agree to undertake a urine pregnancy test upon entering and exiting the study.
- They are not planning to become pregnant during the course of the study.
- They are currently using, and agree to use adequate birth control methods for the duration of the study.
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Any abnormality preventing reliable applanation tonometry in the study eye(s).
- Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
- Dry eye or keratoconjunctivitis sicca (KCS) which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
- Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
- Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
- Any history of ocular infections or inflammatory ocular conditions within the past 3 months in either eye.
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- Use of any systemic medications on a chronic basis that have not been on a stable dosing regimen for at least 30 days prior to Visit 1.
- Use of ocular medications other than XALATAN® within 7 days of Visit 1.
- Use of corticosteroids within 30 days of Visit 1.
- Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
- History of intolerance or hypersensitivity to any component of the test articles.
- Participation in an investigational drug or device study within 30 days of entering this study.
- History or evidence of corneal transplant or transplant variant procedures.
- Other protocol-specified exclusion criteria may apply.
About this study
The purpose of this study is to understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost APS 40 micrograms/ml eye drop solution, Latanoprost 50 micrograms/ml eye drop solution
- Keywords
- Open Angle Glaucoma, Ocular hypertension, OAG, OH
- 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 APS 40 micrograms/ml eye drop solutionDrug
non-BAK (benzalkonium chloride) medication
Latanoprost 50 micrograms/ml eye drop solutionDrug
Also called XALATAN®
BAK-preserved medication
| Study group | Role | What they receive |
|---|---|---|
| Travoprost APS | Experimental | Travoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days Receives: Drug: Travoprost APS 40 micrograms/ml eye drop solution |
| XALATAN | Active comparator | Latanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days Receives: Drug: Latanoprost 50 micrograms/ml eye drop solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theresa Landry, Ph.D., Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892762
- Sponsor's protocol ID
- C-09-001
- Status last verified
- Jul 2014
- First submitted
- 4 May 2009
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Travoprost APS Versus Xalatan® in Patient Reported Outcomes and Ocular Surface Health
- ClinicalTrials.gov ID
- NCT00892762
- Acronym / sponsor ID
- C-09-001
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Open Angle Glaucoma, Ocular hypertension, OAG, OH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 5 May 2009 (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 understand differences in visual function-related patient-reported outcomes between a non-BAK medication (Travoprost APS) and a BAK-preserved medication (XALATAN®) in patients with open-angle glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Travoprost APS | Experimental | Drug: Travoprost APS 40 micrograms/ml eye drop solutionTravoprost APS 40 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days |
| XALATAN | Active comparator | Drug: Latanoprost 50 micrograms/ml eye drop solutionLatanoprost 50 micrograms/ml eye drop solution, 1 drop in the study eye(s), once daily each evening, for 90 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least 1 eye.
- Must be willing and able to discontinue use of any topical ocular medication other than the study medication for the duration of the study.
- Must have had Intraocular Pressure (IOP) controlled with mono-therapy using XALATAN® for at least 1 continuous month prior to Visit 1.
- Women of childbearing potential must meet all of the following conditions at Visit 1:
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (14 listed)
- Any abnormality preventing reliable applanation tonometry in the study eye(s).
- Presence of any ocular pathology in either eye seen during the slit lamp or fundus exams, that in the opinion of the Investigator may preclude the safe administration of test article or safe participation in this study.
- Dry eye or keratoconjunctivitis sicca (KCS) which has been, or is currently being, treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
- Patients who have undergone keratorefractive ocular laser procedures, corneal surgery or surgery to the corneal surface, including but not limited to LASIK and PRK, within 6 months prior to Visit 1.
- Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
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 APS 40 micrograms/ml eye drop solutionnon-BAK (benzalkonium chloride) medication | Drug | Travoprost APS |
| Latanoprost 50 micrograms/ml eye drop solutionAlso: XALATAN®BAK-preserved medication | Drug | XALATAN |
Primary outcome
Mean NEI VFQ-25 composite score at the end of the treatment period (Day 90)
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2014.
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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.
Theresa Landry, Ph.D. study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Travoprost APS 40 micrograms/ml eye drop solution and Latanoprost 50 micrograms/ml eye drop solution 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 10 inclusion and 14 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 15 Jul 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NEI VFQ-25 composite score at the end of the treatment period (Day 90) (time frame: Day 90). 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 15 Jul 2014.