Ocular HypertensionPhase 3NCT00751049
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
A Phase 3 study testing timolol and PhXA41 in people with Ocular Hypertension and Open Angle Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 12 sites in United Kingdom.
Trial summary
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- timolol and PhXA41
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 12 sitesUnited Kingdom
- Study dates
- Dec 1992to Dec 1993
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
- Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
- IOP of 22mmHg or higher obtained during the pre-study period.
- Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:
- 3 weeks for B-adrenergic antagonists
- 2 weeks for adrenergic agonists
- 5 days for cholinergics and oral carbonic anhydrase inhibitors.
Who cannot join
- History of acute angle closure.
- Severe trauma at any time.
- Intraocular surgery or argon laser trabeculoplasty within 6 months.
- Current use of contact lenses.
- History of severe dry eye syndrome.
- Ocular inflammation/infection with three months of inclusion.
Show all 13Show fewer
- Any condition preventing reliable applanation tonometry.
- Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
- In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
- Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
- Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
- Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
- Having participated in any other clinical study within the last month.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United Kingdom12 sites
Pfizer Investigational Site
Aberdeen, Grampian, AB25 2ZD
Pfizer Investigational Site
Bristol, BS1 2LX
Pfizer Investigational Site
Cambridge
Pfizer Investigational Site
Cardiff, CF4 4XW
Pfizer Investigational Site
Dundee, DD2 9SY
Pfizer Investigational Site
Liverpool, L7 8XP
Pfizer Investigational Site
London, NW3 2QG
Pfizer Investigational Site
London
Pfizer Investigational Site
Manchester
Pfizer Investigational Site
Nottingham, Notts., NG7 2UH
Pfizer Investigational Site
Paisley
Pfizer Investigational Site
Sheffield, S10 2JF
About this study
Official title: A 6-month, Randomized, Double-masked Comparison of PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in the United Kingdom
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- timolol, PhXA41
- Keywords
- open angle glaucoma ocular hypertension
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
timololDrug
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
PhXA41Drug
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
| Study group | Role | What they receive |
|---|---|---|
| PhXA41 | Experimental | Not described Receives: Drug: PhXA41 |
| timolol | Active comparator | Not described Receives: Drug: timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment
Measured: 6 mos
Secondary outcomes (1)
to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.
Measured: 6 mos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2008 (estimated)
- Study startDec 1992
- Primary completionDec 1993
- Study completionDec 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular HypertensionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 294 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751049
- Sponsor's protocol ID
- 9200PG005
- Other IDs
- A6111129
- Status last verified
- Sep 2008
- First submitted
- 10 Sep 2008
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9.
PubMed 19427617
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Randomized, Double-masked Comparison of PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-centre Study in the United Kingdom
- ClinicalTrials.gov ID
- NCT00751049
- Acronym / sponsor ID
- 9200PG005
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- open angle glaucoma ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 294 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 1992
- Primary completion
- Dec 1993 (actual)
- Study completion
- Dec 1993 (actual)
- First posted
- 11 Sep 2008 (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.
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PhXA41 | Experimental | Drug: PhXA41 |
| timolol | Active comparator | Drug: timolol |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
- Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
- IOP of 22mmHg or higher obtained during the pre-study period.
- Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:
Key exclusion criteria (13 listed)
- History of acute angle closure.
- Severe trauma at any time.
- Intraocular surgery or argon laser trabeculoplasty within 6 months.
- Current use of contact lenses.
- History of severe dry eye syndrome.
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 |
|---|---|---|
| timololOne drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle | Drug | timolol |
| PhXA41One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle. | Drug | PhXA41 |
Primary outcome
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment
Time frame: 6 mos
1 secondary outcome
to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.
Time frame: 6 mos
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 2 Feb 2021.
- Derived from this study: PubMed 19427617Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing timolol and PhXA41 in people with Ocular Hypertension and Open Angle Glaucoma, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 12 sites in United Kingdom.
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 7 inclusion and 13 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 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom. 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 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?
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment (time frame: 6 mos). 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 NCT00751049, which also lists 1 linked publication.
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 2 Feb 2021.