Open-Angle GlaucomaPhase 4DVXNCT00887029
A 12 Week Comparison of DuoTrav and Xalacom in Open-Angle Glaucoma
A Phase 4 study testing DuoTrav (travoprost-timolol ophthalmic drops) and Xalacom (latanoprost-timolol ophthalmic drops) in people with Open-Angle Glaucoma and Ocular Hypertension, run by Ophthalmic Consultants Centres, Canada at 2 sites in Canada.
Trial summary
Hypothesis: H1: Efficacy of Duotrav will be superior to Xalacom at 24 hours post dosing when both medications are given in the morning H2: A significant proportion of patients will prefer dosing of once daily topical fixed combination therapy in the morning compared to evening dosing Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open-Angle Glaucoma, Ocular Hypertension
- What is being tested?
- DuoTrav (travoprost-timolol ophthalmic drops) and Xalacom (latanoprost-timolol ophthalmic drops)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2009to Nov 2009
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years old, diagnosed with primary open angle glaucoma or ocular hypertension
- IOP currently uncontrolled on beta blocker monotherapy, as judged by the investigator
- Response to Timolol 0.5% was a ≥10% reduction in IOP
- IOP at 9:00 of ≥ 20 mmHg while still on beta blocker
- Non-prescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study.
- Patients wearing contact lenses will be permitted to participate in the study provided that the contact lenses are removed during instillation of study medication and that the patient waits fifteen (15) minutes following drug instillation to re-insert the lenses. Contact lenses cannot be worn on study days.
Who cannot join
- Best corrected visual acuity worse than 0.6 logMAR or 20/80 Snellen in either eye.
- Patients in whom the mean IOP in either eye at the screening exam visit is greater than 36 mmHg
- History of ocular trauma within the past six (6) months.
- History of ocular infection or ocular inflammation within the past three (3) months.
- History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis)
- History of severe or serious hypersensitivity to any components of the study medications.
Show all 19Show fewer
- Any abnormality preventing reliable applanation tonometry of either eye.
- Intraocular surgery within the past six (6) months as determined by patient history and/or examination.
- Patients with cup/disc ratio greater than 0.80 in either eye.
- Patients with severe central visual field loss in either eye defined as a sensitivity 10 dB in at least two (2) of the four (4) visual field test points closest to the point of fixation.
- History of severe retinal disease such as retinal degeneration, diabetic retinopathy or retinal detachment.
- Current use of ANY glucocorticoid administered by any route. Patient must have washed out of the glucocorticoid for at least 4 weeks prior to study entry.
- Use of any systemic prostaglandin or prostaglandin analogue (e.g., CYTOTEC) within the last three months.
- Current use of topical non-steroidal anti inflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis.
- Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component).
- Current use of topical non-steroidal anti inflammatory agents which inhibit cyclo-oxygenase and prostaglandin analogue synthesis
- Angle grade less than 2 (extreme narrow angle with complete or partial closure) as measured by gonioscopy.
- Therapy with another investigational agent within the past 30 days
- Patients who would be at risk from treatment with a topical prostaglandin or prostaglandin analogue, are contraindicated for use of beta-blockers or any other medication used in this study, or who would be at risk from participation in the study.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Ophthalmic Consultant Centres
Mississauga, Ontario, L4W1W9
Dr David B. Yan, M.D., F.R.C.S.C.
Toronto, Ontario, M5R2M8
About this study
Official title: A 12 Week Comparison of DuoTrav and Xalacom at 24 Hours Post-Dose in the Treatment of Open-Angle Glaucoma (the DVX Study)
Hypothesis:
- H1: Efficacy of Duotrav will be superior to Xalacom at 24 hours post dosing when both medications are given in the morning
- H2: A significant proportion of patients will prefer dosing of once daily topical fixed combination therapy in the morning compared to evening dosing
Read the detailed description
- Primary objective: Compare IOP-lowering efficacy of morning dosing of Duotrav to Xalacom.
- Secondary objective: Compare patient dosing preferences for topical prostaglandin therapy in terms of convenience and perceived compliance.
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Being tested
- DuoTrav (travoprost-timolol ophthalmic drops), Xalacom (latanoprost-timolol ophthalmic drops)
- Keywords
- Topical prostaglandin analogue, glaucoma, POAG, OHT, OAG, ocular hypertension, fixed combination protaglandin analogue therapy, DuoTrav, timolol, travoprost, 24 hour post dose, IOP, dosing preference
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuoTrav (travoprost-timolol ophthalmic drops)Drug
Also called DuoTrav
topical ophthalmic drops instilled 1 drop daily
Xalacom (latanoprost-timolol ophthalmic drops)Drug
Also called Xalacom
topical ophthalmic drops instilled 1 drop daily
| Study group | Role | What they receive |
|---|---|---|
| DuoTrav | Active comparator | Not described Receives: Drug: DuoTrav (travoprost-timolol ophthalmic drops) |
| Xalacom | Active comparator | Not described Receives: Drug: Xalacom (latanoprost-timolol ophthalmic drops) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP lowering efficacy of DuoTrav and Xalacom
Measured: 12 weeks
Secondary outcomes (1)
To compare patient dosing preferences in terms of convenience and perceived compliance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Open-Angle GlaucomaStudies of the same condition, open and under way.
- 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
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants Centres, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- David B Yan, MD, Principal investigator, Ophthalmic Consultant CentresNavroop Gill, OD, Study chair, Ophthalmic Consultant Centres
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887029
- Sponsor's protocol ID
- OCC1023
- Acronym
- DVX
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2009
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Netland PA, Landry T, Sullivan EK, Andrew R, Silver L, Weiner A, Mallick S, Dickerson J, Bergamini MV, Robertson SM, Davis AA; Travoprost Study Group. Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001 Oct;132(4):472-84. doi: 10.1016/s0002-9394(01)01177-1.
PubMed 11589866Dubiner HB, Sircy MD, Landry T, Bergamini MV, Silver LH, Darell Turner F, Robertson S, Andrew RM, Weiner A, Przydryga J. Comparison of the diurnal ocular hypotensive efficacy of travoprost and latanoprost over a 44-hour period in patients with elevated intraocular pressure. Clin Ther. 2004 Jan;26(1):84-91. doi: 10.1016/s0149-2918(04)90008-2.
PubMed 14996520Topouzis F, Melamed S, Danesh-Meyer H, Wells AP, Kozobolis V, Wieland H, Andrew R, Wells D. A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. Eur J Ophthalmol. 2007 Mar-Apr;17(2):183-90. doi: 10.1177/112067210701700206.
PubMed 17415690Diestelhorst M, Larsson LI; European Latanoprost Fixed Combination Study Group. A 12 week study comparing the fixed combination of latanoprost and timolol with the concomitant use of the individual components in patients with open angle glaucoma and ocular hypertension. Br J Ophthalmol. 2004 Feb;88(2):199-203. doi: 10.1136/bjo.2003.018234.
PubMed 14736774Yan DB, Battista RA, Haidich AB, Konstas AG. Comparison of morning versus evening dosing and 24-h post-dose efficacy of travoprost compared with latanoprost in patients with open-angle glaucoma. Curr Med Res Opin. 2008 Nov;24(11):3023-7. doi: 10.1185/03007990802426813. Epub 2008 Oct 14.
PubMed 18826749Alm A, Stjernschantz J. Effects on intraocular pressure and side effects of 0.005% latanoprost applied once daily, evening or morning. A comparison with timolol. Scandinavian Latanoprost Study Group. Ophthalmology. 1995 Dec;102(12):1743-52. doi: 10.1016/s0161-6420(95)30798-1.
PubMed 9098273
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12 Week Comparison of DuoTrav and Xalacom at 24 Hours Post-Dose in the Treatment of Open-Angle Glaucoma (the DVX Study)
- ClinicalTrials.gov ID
- NCT00887029
- Acronym / sponsor ID
- DVX / OCC1023
- Conditions
- Open-Angle Glaucoma, Ocular Hypertension
- Keywords
- Topical prostaglandin analogue, glaucoma, POAG, OHT, OAG, ocular hypertension, fixed combination protaglandin analogue therapy, DuoTrav
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ophthalmic Consultants Centres, CanadaUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 23 Apr 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.
Hypothesis:
- H1: Efficacy of Duotrav will be superior to Xalacom at 24 hours post dosing when both medications are given in the morning
- H2: A significant proportion of patients will prefer dosing of once daily topical fixed combination therapy in the morning compared to evening dosing
Detailed description
- Primary objective: Compare IOP-lowering efficacy of morning dosing of Duotrav to Xalacom.
- Secondary objective: Compare patient dosing preferences for topical prostaglandin therapy in terms of convenience and perceived compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuoTrav | Active comparator | Drug: DuoTrav (travoprost-timolol ophthalmic drops) |
| Xalacom | Active comparator | Drug: Xalacom (latanoprost-timolol ophthalmic drops) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients ≥ 18 years old, diagnosed with primary open angle glaucoma or ocular hypertension
- IOP currently uncontrolled on beta blocker monotherapy, as judged by the investigator
- Response to Timolol 0.5% was a ≥10% reduction in IOP
- IOP at 9:00 of ≥ 20 mmHg while still on beta blocker
- Non-prescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study.
Key exclusion criteria (19 listed)
- Best corrected visual acuity worse than 0.6 logMAR or 20/80 Snellen in either eye.
- Patients in whom the mean IOP in either eye at the screening exam visit is greater than 36 mmHg
- History of ocular trauma within the past six (6) months.
- History of ocular infection or ocular inflammation within the past three (3) months.
- History of chronic or recurrent severe inflammatory eye disease (i.e., scleritis, uveitis)
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 (travoprost-timolol ophthalmic drops)Also: DuoTravtopical ophthalmic drops instilled 1 drop daily | Drug | DuoTrav |
| Xalacom (latanoprost-timolol ophthalmic drops)Also: Xalacomtopical ophthalmic drops instilled 1 drop daily | Drug | Xalacom |
Primary outcome
IOP lowering efficacy of DuoTrav and Xalacom
Time frame: 12 weeks
1 secondary outcome
To compare patient dosing preferences in terms of convenience and perceived compliance
Time frame: 12 weeks
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 21 Apr 2015.
- Results publication: PubMed 11589866Netland PA, Landry T, Sullivan EK, Andrew R, Silver L, Weiner A, Mallick S, Dickerson J, Bergamini MV, Robertson SM, Davis AA; Travoprost Study Group. Travoprost compared with latanoprost and timolol in patients with open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001 Oct;132(4):472-84. doi: 10.1016/s0002-9394(01)01177-1.
- Results publication: PubMed 14996520Dubiner HB, Sircy MD, Landry T, Bergamini MV, Silver LH, Darell Turner F, Robertson S, Andrew RM, Weiner A, Przydryga J. Comparison of the diurnal ocular hypotensive efficacy of travoprost and latanoprost over a 44-hour period in patients with elevated intraocular pressure. Clin Ther. 2004 Jan;26(1):84-91. doi: 10.1016/s0149-2918(04)90008-2.
- Results publication: PubMed 17415690Topouzis F, Melamed S, Danesh-Meyer H, Wells AP, Kozobolis V, Wieland H, Andrew R, Wells D. A 1-year study to compare the efficacy and safety of once-daily travoprost 0.004%/timolol 0.5% to once-daily latanoprost 0.005%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. Eur J Ophthalmol. 2007 Mar-Apr;17(2):183-90. doi: 10.1177/112067210701700206.
- Results publication: PubMed 14736774Diestelhorst M, Larsson LI; European Latanoprost Fixed Combination Study Group. A 12 week study comparing the fixed combination of latanoprost and timolol with the concomitant use of the individual components in patients with open angle glaucoma and ocular hypertension. Br J Ophthalmol. 2004 Feb;88(2):199-203. doi: 10.1136/bjo.2003.018234.
- Results publication: PubMed 18826749Yan DB, Battista RA, Haidich AB, Konstas AG. Comparison of morning versus evening dosing and 24-h post-dose efficacy of travoprost compared with latanoprost in patients with open-angle glaucoma. Curr Med Res Opin. 2008 Nov;24(11):3023-7. doi: 10.1185/03007990802426813. Epub 2008 Oct 14.
- Results publication: PubMed 9098273Alm A, Stjernschantz J. Effects on intraocular pressure and side effects of 0.005% latanoprost applied once daily, evening or morning. A comparison with timolol. Scandinavian Latanoprost Study Group. Ophthalmology. 1995 Dec;102(12):1743-52. doi: 10.1016/s0161-6420(95)30798-1.
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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.
David B Yan, MD principal investigator
Ophthalmic Consultant Centres
Navroop Gill, OD study chair
Ophthalmic Consultant Centres
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DuoTrav (travoprost-timolol ophthalmic drops) and Xalacom (latanoprost-timolol ophthalmic drops) in people with Open-Angle Glaucoma and Ocular Hypertension, run by Ophthalmic Consultants Centres, Canada at 2 sites in Canada.
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 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 21 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 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?
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?
IOP lowering efficacy of DuoTrav and Xalacom (time frame: 12 weeks). 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 NCT00887029, which also lists 6 linked publications.
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 21 Apr 2015.