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

Glaucoma, Open-Angle Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863705
• Other study ID #: CMO-AP-EYE-0428
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Low Tension Glaucoma
• Normal Tension Glaucoma

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