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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02863705
Other study ID # CMO-AP-EYE-0428
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 5, 2016
Est. completion date July 25, 2018

Study information

Verified date August 2018
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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%.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date July 25, 2018
Est. primary completion date July 25, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)

- Previous history of topical beta-blocker use and insufficiently controlled IOP

Exclusion Criteria:

- 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

Study Design


Intervention

Drug:
brimonidine tartrate/timolol malate Ophthalmic Solution
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%
Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed

Locations

Country Name City State
Korea, Republic of Pusan National University Hospital, Pusan National University School of Medicine Busan
Korea, Republic of Yeungnam University Hospital, Yeungnam University College of Medicine Daegu
Korea, Republic of Chungnam National University Hospital, Chungnam National University College of Medicine Daejeon
Korea, Republic of Chonnam National University Hospital, Chonnam National University Medical School Gwangju
Korea, Republic of Seoul National University Bundang Hospital, Seoul National University College of Medicine Gyeonggi-do
Korea, Republic of Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine Seoul
Korea, Republic of Kim's Eye Hospital, Konyang University College of Medicine Seoul
Korea, Republic of Seoul National University Hospital, Seoul National University College of Medicine Seoul
Korea, Republic of Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine Seoul

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean IOP change from Baseline (11AM point) Baseline, Month 12
Secondary 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%
Baseline, Month 12
Secondary 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%
Baseline, Month 12
Secondary Mean change in Mean deviation (MD) from Baseline Baseline, Month 12
Secondary Mean change in Pattern standard deviation (PSD) from Baseline Baseline, Month 12
Secondary Mean change in Visual field index (VFI) from Baseline Baseline, Month 12
Secondary Mean change in cup to disc ratio (C/D ratio) from Baseline Baseline, Month 12
Secondary 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%
Baseline, Month 12
Secondary Mean duration of achieving the target IOP with COMBIGAN® alone 12 Months
Secondary The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months 12 Months
Secondary 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%
Baseline, Month 12
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