Efficacy and Safety of COMBIGAN® in Korean Patients With Primary Open Angle Glaucoma (POAG) and Normal Tension Glaucoma (NTG)

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%.

Study Overview

• Status: Completed
• Conditions: Glaucoma, Open-Angle; Normal Tension Glaucoma
• Intervention / Treatment: Drug: brimonidine tartrate/timolol malate Ophthalmic Solution; Drug: bimatoprost ophthalmic solution 0.01%

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital, Pusan National University School of Medicine
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Hospital, Yeungnam University College of Medicine
  • Daejeon, Korea, Republic of, 35015
    • Chungnam National University Hospital, Chungnam National University College of Medicine
  • Gwangju, Korea, Republic of, 61469
    • Chonnam National University Hospital, Chonnam National University Medical School
  • Gyeonggi-do, Korea, Republic of, 13619
    • Seoul National University Bundang Hospital, Seoul National University College of Medicine
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital, Seoul National University College of Medicine
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
  • Seoul, Korea, Republic of, 06591
    • Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
  • Seoul, Korea, Republic of, 07301
    • Kim's Eye Hospital, Konyang University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COMBIGAN®; One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months	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
Experimental: COMBIGAN® + LUMIGAN® 0.01%; LUMIGAN® will be administered once daily in the evening 5 minutes after COMBIGAN® instillation in patients who require additional IOP lowering.	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; Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean IOP change from Baseline (11AM point)	Baseline, Month 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Joy Maglambayan, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2016
• Primary Completion (Actual): July 25, 2018
• Study Completion (Actual): July 25, 2018

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Optic Nerve Diseases; Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Timolol; Brimonidine Tartrate; Ophthalmic Solutions; Pharmaceutical Solutions; Bimatoprost
• Other Study ID Numbers: CMO-AP-EYE-0428

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No