Clinical trial NCT02863705: Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Normal Tension Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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%.


Eligibility criteria: 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

Primary outcomes:
measure: Mean IOP change from Baseline (11AM point)
timeFrame: Baseline, Month 12
Secondary outcomes:
measure: Mean IOP change from Baseline (11AM point)
timeFrame: Baseline, Month 12
measure: Mean IOP change from Baseline (9AM point)
timeFrame: Baseline, Month 12
measure: Mean change in Mean deviation (MD) from Baseline
timeFrame: Baseline, Month 12
measure: Mean change in Pattern standard deviation (PSD) from Baseline
timeFrame: Baseline, Month 12
measure: Mean change in Visual field index (VFI) from Baseline
timeFrame: Baseline, Month 12
measure: Mean change in cup to disc ratio (C/D ratio) from Baseline
timeFrame: Baseline, Month 12
measure: Rate of VF progression measured as change in VF index over time
timeFrame: Baseline, Month 12
measure: Mean duration of achieving the target IOP with COMBIGAN® alone
timeFrame: 12 Months
measure: The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months
timeFrame: 12 Months
measure: Definition of patient demographics (descriptive analysis of age and gender)
timeFrame: Baseline, Month 12
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital, Pusan National University School of Medicine
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital, Yeungnam University College of Medicine
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital, Chungnam National University College of Medicine
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital, Chonnam National University Medical School
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital, Seoul National University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Seoul National University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital, Konyang University College of Medicine
Study officials:
affiliation: Allergan
name: Joy Maglambayan
role: STUDY_DIRECTOR
References: