Glaucoma, Open-AnglePhase 4NCT02863705
Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
A Phase 4 study testing brimonidine tartrate/timolol malate Ophthalmic Solution and bimatoprost ophthalmic solution 0.01% in people with Glaucoma, Open-Angle and Normal Tension Glaucoma, run by Allergan at 9 sites in South Korea.
Trial summary
The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Normal Tension Glaucoma
- What is being tested?
- brimonidine tartrate/timolol malate Ophthalmic Solution and bimatoprost ophthalmic solution 0.01%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 5 Jul 2016to 25 Jul 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
- Previous history of topical beta-blocker use and insufficiently controlled IOP
Who cannot join
- Pigmentary or exfoliative glaucoma
- History of angle-closure or an occludable angle by gonioscopy
- Prior filtration or laser iridotomy
- Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months
- History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Pusan National University Hospital, Pusan National University School of Medicine
Busan, 49241
Yeungnam University Hospital, Yeungnam University College of Medicine
Daegu, 42415
Chungnam National University Hospital, Chungnam National University College of Medicine
Daejeon, 35015
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, 61469
Seoul National University Bundang Hospital, Seoul National University College of Medicine
Gyeonggi-do, 13619
Seoul National University Hospital, Seoul National University College of Medicine
Seoul, 03080
Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 03181
Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
Seoul, 06591
Kim's Eye Hospital, Konyang University College of Medicine
Seoul, 07301
About this study
Official title: A 12-Month, Phase 4, Open Label, Multicenter, Trial to Assess the Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.
- Conditions
- Glaucoma, Open-Angle, Normal Tension Glaucoma
- Being tested
- brimonidine tartrate/timolol malate Ophthalmic Solution, bimatoprost ophthalmic solution 0.01%
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brimonidine tartrate/timolol malate Ophthalmic SolutionDrug
One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months
bimatoprost ophthalmic solution 0.01%Drug
Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed
| Study group | Role | What they receive |
|---|---|---|
| COMBIGAN® | Experimental | One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months Receives: Drug: brimonidine tartrate/timolol malate Ophthalmic Solution |
| COMBIGAN® + LUMIGAN® 0.01% | Experimental | LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering. Receives: Drug: brimonidine tartrate/timolol malate Ophthalmic Solution; Drug: bimatoprost ophthalmic solution 0.01% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP change from Baseline (11AM point)
Measured: Baseline, Month 12
Secondary outcomes (10)
Mean IOP change from Baseline (11AM point)
Mean IOP change from baseline (11AM point) in the following patient sub-groups
- patients with NTG
- patients with POAG
- patients taking Combigan alone
- patients taking Combigan plus additional Lumigan 0.01%
Measured: Baseline, Month 12
Mean IOP change from Baseline (9AM point)
Mean IOP change from baseline (9AM point) in the following patient sub-groups
- patients with NTG
- patients with POAG
- patients taking Combigan alone
- patients taking Combigan plus additional Lumigan 0.01%
Measured: Baseline, Month 12
Mean change in Mean deviation (MD) from Baseline
Measured: Baseline, Month 12
Mean change in Pattern standard deviation (PSD) from Baseline
Measured: Baseline, Month 12
Mean change in Visual field index (VFI) from Baseline
Measured: Baseline, Month 12
Mean change in cup to disc ratio (C/D ratio) from Baseline
Measured: Baseline, Month 12
Rate of VF progression measured as change in VF index over time
Rate of VF progression during 12 months in the following patient sub-groups.
- patients with NTG
- patients with POAG
- patients taking Combigan alone
- patients taking Combigan plus additional Lumigan 0.01%
Measured: Baseline, Month 12
Mean duration of achieving the target IOP with COMBIGAN® alone
Measured: 12 Months
The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months
Measured: 12 Months
Definition of patient demographics (descriptive analysis of age and gender)
Define patient demographics in the following patient sub-groups:
- patients with NTG
- patients with POAG
- patients taking Combigan alone
- patients taking Combigan plus additional Lumigan 0.01%
Measured: Baseline, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study start5 Jul 2016
- Primary completion25 Jul 2018
- Study completion25 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joy Maglambayan, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863705
- Sponsor's protocol ID
- CMO-AP-EYE-0428
- Status last verified
- Aug 2018
- First submitted
- 2 May 2016
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-Month, Phase 4, Open Label, Multicenter, Trial to Assess the Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
- ClinicalTrials.gov ID
- NCT02863705
- Acronym / sponsor ID
- CMO-AP-EYE-0428
- Conditions
- Glaucoma, Open-Angle, Normal Tension Glaucoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2016 (actual)
- Primary completion
- 25 Jul 2018 (actual)
- Study completion
- 25 Jul 2018 (actual)
- First posted
- 11 Aug 2016 (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.
The objective of this study is to evaluate the long-term efficacy and safety of COMBIGAN® (brimonidine tartrate/timolol malate) in patients only using COMBIGAN® (brimonidine tartrate/timolol malate) and also in patients who require additional IOP lowering with LUMIGAN® (bimatoprost) 0.01%.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COMBIGAN® | Experimental | Drug: brimonidine tartrate/timolol malate Ophthalmic SolutionOne drop of COMBIGAN® in the affected eye, administered twice daily for 12 months |
| COMBIGAN® + LUMIGAN® 0.01% | Experimental | Drug: brimonidine tartrate/timolol malate Ophthalmic Solution, Drug: bimatoprost ophthalmic solution 0.01%LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
- Previous history of topical beta-blocker use and insufficiently controlled IOP
Key exclusion criteria (5 listed)
- Pigmentary or exfoliative glaucoma
- History of angle-closure or an occludable angle by gonioscopy
- Prior filtration or laser iridotomy
- Argon laser trabeculoplasty or Selective laser trabeculoplasty performed less than 6 months
- History or signs of chronic inflammatory eye disease, ocular trauma, or potentially progressive retinal disease
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 |
|---|---|---|
| brimonidine tartrate/timolol malate Ophthalmic SolutionOne drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months | Drug | COMBIGAN®, COMBIGAN® + LUMIGAN® 0.01% |
| bimatoprost ophthalmic solution 0.01%Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed | Drug | COMBIGAN® + LUMIGAN® 0.01% |
Primary outcome
Mean IOP change from Baseline (11AM point)
Time frame: Baseline, Month 12
10 secondary outcomes
Mean IOP change from Baseline (11AM point)
Time frame: Baseline, Month 12
Mean IOP change from Baseline (9AM point)
Time frame: Baseline, Month 12
Mean change in Mean deviation (MD) from Baseline
Time frame: Baseline, Month 12
Mean change in Pattern standard deviation (PSD) from Baseline
Time frame: Baseline, Month 12
Mean change in Visual field index (VFI) from Baseline
Time frame: Baseline, Month 12
Mean change in cup to disc ratio (C/D ratio) from Baseline
Time frame: Baseline, Month 12
Rate of VF progression measured as change in VF index over time
Time frame: Baseline, Month 12
Mean duration of achieving the target IOP with COMBIGAN® alone
Time frame: 12 Months
The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months
Time frame: 12 Months
Definition of patient demographics (descriptive analysis of age and gender)
Time frame: Baseline, Month 12
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 31 Aug 2018.
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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.
Joy Maglambayan study director
Allergan
9 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 brimonidine tartrate/timolol malate Ophthalmic Solution and bimatoprost ophthalmic solution 0.01% in people with Glaucoma, Open-Angle and Normal Tension Glaucoma, run by Allergan at 9 sites in South Korea.
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 2 inclusion and 5 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 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in South Korea. 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?
Mean IOP change from Baseline (11AM point) (time frame: Baseline, Month 12). 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 31 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.