GlaucomaPhase 4NCT00735449
Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
A Phase 4 study testing Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%, timolol maleate 0.5% and latanoprost 0.005% in people with Glaucoma and Ocular Hypertension, run by Allergan at 2 sites in 2 countries.
Trial summary
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%, timolol maleate 0.5% and latanoprost 0.005%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2008to Dec 2009
- Phase
- Phase 4
- 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
- Be at least 18 years of age
- Give written informed consent
- Be in good general health as determined by your doctor
- Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension
- If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills)
- Understand the study instructions, and be able to follow the study instructions; and
- Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits
Who cannot join
- Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
- History of severe renal or hepatic impairment
- Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist
- Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure
- Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
- Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the screening visit
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%, timolol maleate 0.5%, latanoprost 0.005%
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%Drug
Also called Combigan®
1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
timolol maleate 0.5%Drug
Also called Timpoptic®, Timoptol®
1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day.
latanoprost 0.005%Drug
Also called Xalatan®
1 drop of latanoprost 0.005% once nightly.
| Study group | Role | What they receive |
|---|---|---|
| Combigan ® | Active comparator | Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%) Receives: Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%; Drug: latanoprost 0.005% |
| Timolol Maleate 0.5% | Active comparator | Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) Receives: Drug: timolol maleate 0.5%; Drug: latanoprost 0.005% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Intraocular Pressure (IOP) at 10 AM at Week 12
Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.
Measured: Week 12
Secondary outcomes (4)
Mean Intraocular Pressure (IOP) at 10 AM at Week 6
Mean IOP at 10 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Measured: Week 6
Mean Intraocular Pressure (IOP) at 8 AM at Week 12
Mean IOP at 8 AM at week 12. IOP is a measurement of the fluid pressure inside the eye.
Measured: Week 12
Mean Intraocular Pressure (IOP) at 8 AM at Week 6
Mean IOP at 8 AM at week 6. IOP is a measurement of the fluid pressure inside the eye.
Measured: Week 6
Number of Subjects With Adverse Events
Number of subjects with adverse events, defined as any untoward medical occurrence in a subject, during the study (reported through the week 12 visit).
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009
- Study completionDec 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735449
- Sponsor's protocol ID
- GMA-COM-07-XTC
- Status last verified
- Apr 2019
- First submitted
- 13 Aug 2008
- Last updated
- 23 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Fechtner RD, Harasymowycz P, Nixon DR, Vold SD, Zaman F, Williams JM, Hollander DA. Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost. Clin Ophthalmol. 2011;5:945-53. doi: 10.2147/OPTH.S19999. Epub 2011 Jul 8.
PubMed 21792284
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects
- ClinicalTrials.gov ID
- NCT00735449
- Acronym / sponsor ID
- GMA-COM-07-XTC
- Conditions
- Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Posted 24 Nov 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combigan ® | Active comparator | Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%, Drug: latanoprost 0.005%Combigan® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%) adjunctive to Xalatan® (latanoprost 0.005%) |
| Timolol Maleate 0.5% | Active comparator | Drug: timolol maleate 0.5%, Drug: latanoprost 0.005%Timolol maleate 0.5% adjunctive to Xalatan® (latanoprost 0.005%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years of age
- Give written informed consent
- Be in good general health as determined by your doctor
- Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension
- If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills)
Key exclusion criteria (6 listed)
- Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation
- History of severe renal or hepatic impairment
- Subjects with severe cardiovascular disease should not be enrolled unless their disease is controlled and clearance has been obtained from the subject's primary care physician and/or cardiologist
- Contraindications to beta-adrenoceptor antagonist therapy such as chronic obstructive pulmonary disease, bronchial asthma, sinus bradycardia, second and third degree atrioventricular block, overt cardiac failure and cardiogenic shock or uncontrolled congestive heart failure
- Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
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 |
|---|---|---|
| Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%Also: Combigan®1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. | Drug | Combigan ® |
| timolol maleate 0.5%Also: Timpoptic®, Timoptol®1 drop of timolol maleate 0.5% taken approximately 12 hours apart, up to 2 times a day. | Drug | Timolol Maleate 0.5% |
| latanoprost 0.005%Also: Xalatan®1 drop of latanoprost 0.005% once nightly. | Drug | Combigan ®, Timolol Maleate 0.5% |
Primary outcome
Mean Intraocular Pressure (IOP) at 10 AM at Week 12
Time frame: Week 12
Mean IOP at 10 AM at week 12. IOP is a measurement of the fluid pressure in the eye.
4 secondary outcomes
Mean Intraocular Pressure (IOP) at 10 AM at Week 6
Time frame: Week 6
Mean Intraocular Pressure (IOP) at 8 AM at Week 12
Time frame: Week 12
Mean Intraocular Pressure (IOP) at 8 AM at Week 6
Time frame: Week 6
Number of Subjects With Adverse Events
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21792284Fechtner RD, Harasymowycz P, Nixon DR, Vold SD, Zaman F, Williams JM, Hollander DA. Twelve-week, randomized, multicenter study comparing a fixed combination of brimonidine-timolol with timolol as therapy adjunctive to latanoprost. Clin Ophthalmol. 2011;5:945-53. doi: 10.2147/OPTH.S19999. Epub 2011 Jul 8.
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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.
Medical Director study director
Allergan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5%, timolol maleate 0.5% and latanoprost 0.005% in people with Glaucoma and Ocular Hypertension, run by Allergan at 2 sites in 2 countries.
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 6 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 23 Apr 2019. 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 United States, 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?
Yes. Results are posted in the registry (first posted 24 Nov 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 (IOP) at 10 AM at Week 12 (time frame: Week 12). 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 NCT00735449, 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 23 Apr 2019.