Open Angle GlaucomaPhase 3NCT00912054
DuoTrav APS Versus XALACOM® in Ocular Surface Health
A Phase 3 study testing DuoTrav APS and Xalacom in people with Open Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Belgium.
Trial summary
To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health 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?
- DuoTrav APS and Xalacom
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to 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
- Patients ≥ 18 years of age.
- Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one 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 IOP controlled with mono-therapy using XALACOM for at least 1 continuous month prior to Visit 1.
- Women of childbearing potential must meet all specific conditions at Visit 1:
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 may preclude the safe administration of test article or safe participation in this study.
- Dry eye or 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, within 1 year prior to Visit1
- Any other ocular laser surgery in either eye within 3 months
- Patients who have undergone intraocular or extra-ocular surgery, in either eye, within 6 months prior to Visit 1.
Show all 21Show fewer
- History of other progressive retinal or optic nerve disease.
- Severe central visual field loss in either eye based upon the clinical judgment of the investigator.
- Any history of, or current evidence of, infectious or inflammatory ocular conditions
- Ocular trauma within 6 months prior to Visit 1 in either eye, as determined by patient history and/or examination.
- History or evidence of corneal transplant or transplant variant procedures
- Patients with suspected or diagnosed Sjogren's syndrome.
- History of or current bronchial asthma, or severe chronic obstructive pulmonary disease
- History of or current severe, unstable or uncontrolled cardiovascular, hepatic, or renal disease.
- History of spontaneous or current hypoglycemia or uncontrolled diabetes.
- History of or current severe allergic rhinitis and bronchial hyper reactivity.
- Intolerance/hypersensitivity to any component of the medication
- 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, or an anticipated change in dosing regimen of medications during the course of the study.
- Use of ocular medications other than XALACOM® within 7 days
- Use of corticosteroids within 30 days of Visit 1, or any anticipated use of corticosteroids during the course of the study.
- Use of contact lenses within 30 days of Visit 1. Concomitant use of contact lenses is also excluded for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health in patients with open angle glaucoma or ocular hypertension.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- DuoTrav APS, Xalacom
- Keywords
- 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.
DuoTrav APSDrug
travoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily
XalacomDrug
XALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DuoTrav APS Receives: Drug: DuoTrav APS |
| 2 | Active comparator | Xalacom Receives: Drug: Xalacom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline (Day 0) in Ocular Surface Disease at the end of the treatment period (Day 90)
Measured: Visits 1 and 3
Secondary outcomes (1)
Percent of patients with a corneal fluorescein staining score of 0 at the end of the treatment period (Day 90)
Measured: Visit 3 (Day 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startMar 2010
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: poor enrollment
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
- 240 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
- NCT00912054
- Sponsor's protocol ID
- C-09-007
- Status last verified
- Jan 2012
- First submitted
- 1 Jun 2009
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DuoTrav APS Versus XALACOM® in Ocular Surface Health
- ClinicalTrials.gov ID
- NCT00912054
- Acronym / sponsor ID
- C-09-007
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- OAG, OH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor enrollment
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 3 Jun 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.
To demonstrate superiority of DuoTrav APS over XALACOM® in Ocular Surface Health 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 |
|---|---|---|
| 1 | Experimental | Drug: DuoTrav APSDuoTrav APS |
| 2 | Active comparator | Drug: XalacomXalacom |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years of age.
- Must have a clinical diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component), or ocular hypertension in at least one 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 IOP controlled with mono-therapy using XALACOM for at least 1 continuous month prior to Visit 1.
- Women of childbearing potential must meet all specific conditions at Visit 1:
Key exclusion criteria (21 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 may preclude the safe administration of test article or safe participation in this study.
- Dry eye or 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, within 1 year prior to Visit1
- Any other ocular laser surgery in either eye within 3 months
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 |
|---|---|---|
| DuoTrav APStravoprost APS 40 micrograms/ml / timolol 5 mg/ml, Eye Drops, Solution, once daily | Drug | 1 |
| XalacomXALACOM® (latanoprost 50 micrograms/ml / timolol 5 mg/ml) Eye Drops, Solution | Drug | 2 |
Primary outcome
Mean change from baseline (Day 0) in Ocular Surface Disease at the end of the treatment period (Day 90)
Time frame: Visits 1 and 3
1 secondary outcome
Percent of patients with a corneal fluorescein staining score of 0 at the end of the treatment period (Day 90)
Time frame: Visit 3 (Day 90)
Results and safety
The study was stopped early (reason given: poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
Related trials for Open Angle Glaucoma
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DuoTrav APS and Xalacom in people with Open Angle Glaucoma and Ocular Hypertension, run by Alcon Research at 1 site in Belgium.
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 5 inclusion and 21 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: stopped early, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was stopped early (reason given: poor enrollment). Results are not available in the source record.
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 change from baseline (Day 0) in Ocular Surface Disease at the end of the treatment period (Day 90) (time frame: Visits 1 and 3). 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 19 Jul 2012.