Open Angle GlaucomaPhase 3NCT00848536
Efficacy Study of Travoprost APS Versus TRAVATAN
A Phase 3 study testing Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution and Travoprost 0.004% (BAK-preserved) Eye Drops, Solution in people with Open Angle Glaucoma and Ocular Hypertension, run by Alcon Research.
Trial summary
A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN 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 0.004% (POLYQUAD-preserved) Eye Drops, Solution and Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Jan 2010
- Phase
- Phase 3
- 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
- 18 years of age or older, either gender and any race.
- Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
- Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.
- All patients: Mean IOP in same eye (at both Eligibility 1 \& 2 Visits):
- ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM \& 4 PM.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Females of childbearing potential not meeting conditions set in the protocol.
- Severe central visual field loss.
- Angle Shaffer grade < 2.
- Cup/disc ratio > 0.8 (horizontal or vertical measurement).
- Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
- Intraocular surgery or trauma within last 6 months.
Show all 14Show fewer
- Any abnormality preventing reliable applanation tonometry.
- History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.
- Allergy/hypersensitivity to study medications.
- Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.
- Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
- Use of any additional topical or systemic ocular hypotensive medication during the study.
- Therapy with another investigational agent within 30 days prior to the Screening visit.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Multi-Center, Double-Masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution, Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
- Keywords
- OAG, OHT
- 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 0.004% (POLYQUAD-preserved) Eye Drops, SolutionDrug
One drop once daily in the evening for 3 months
Travoprost 0.004% (BAK-preserved) Eye Drops, SolutionDrug
One drop once daily in the evening for 3 months
| Study group | Role | What they receive |
|---|---|---|
| TRAVATAN APS | Experimental | One drop once daily in the evening for 3 months Receives: Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution |
| TRAVATAN | Active comparator | One drop once daily in the evening for 3 months Receives: Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure at 9:00 am
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg
All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.
Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Measured: 3 months (measured at 9:00 am)
Mean Intraocular Pressure at 11:00 am
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg
All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.
Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Measured: 3 months (measured at 11:00 am)
Mean Intraocular Pressure at 4:00 pm
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg
All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer.
Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Measured: 3 months (measured at 4:00 pm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 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 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
- 371 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
- NCT00848536
- Sponsor's protocol ID
- C-08-40
- Other IDs
- 2008-006027-31, 2008
- Status last verified
- Apr 2012
- First submitted
- 19 Feb 2009
- Last updated
- 6 Apr 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 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00848536
- Acronym / sponsor ID
- C-08-40
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- OAG, OHT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Posted 8 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN 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 |
|---|---|---|
| TRAVATAN APS | Experimental | Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, SolutionOne drop once daily in the evening for 3 months |
| TRAVATAN | Active comparator | Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, SolutionOne drop once daily in the evening for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older, either gender and any race.
- Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
- Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.
- All patients: Mean IOP in same eye (at both Eligibility 1 \& 2 Visits):
- ≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM \& 4 PM.
Key exclusion criteria (14 listed)
- Females of childbearing potential not meeting conditions set in the protocol.
- Severe central visual field loss.
- Angle Shaffer grade < 2.
- Cup/disc ratio > 0.8 (horizontal or vertical measurement).
- Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
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% (POLYQUAD-preserved) Eye Drops, SolutionOne drop once daily in the evening for 3 months | Drug | TRAVATAN APS |
| Travoprost 0.004% (BAK-preserved) Eye Drops, SolutionOne drop once daily in the evening for 3 months | Drug | TRAVATAN |
Primary outcome
Mean Intraocular Pressure at 9:00 am
Time frame: 3 months (measured at 9:00 am)
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Mean Intraocular Pressure at 11:00 am
Time frame: 3 months (measured at 11:00 am)
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Mean Intraocular Pressure at 4:00 pm
Time frame: 3 months (measured at 4:00 pm)
For an individual patient, two consecutive IOP measurements for each eye were taken. The mean IOP values for each individual patient's eye were rounded up to the next whole number if the value was ≥ 0.5 mmHg All IOP measurements were performed with a Goldmann applanation tonometer. All IOP measurements for any individual subject were to be performed preferably by the same operator using the same tonometer. Mean IOP for the patient's worse eye at baseline was used in the primary endpoint analysis. If both eyes were equal, then the right eye was selected for analysis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 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 3 study testing Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution and Travoprost 0.004% (BAK-preserved) Eye Drops, 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 6 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 6 Apr 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 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?
Yes. Results are posted in the registry (first posted 8 Mar 2011). 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 at 9:00 am (time frame: 3 months (measured at 9:00 am)). The study lists 3 primary outcomes in all. 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 6 Apr 2012.