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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02863705
• Collaborator: (none)
• Enrollment: 118
• Locations: 9
• Arms: 2
• Actual Duration (Months): 24.6
• Patients Per Site: 13.1
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Normal Tension Glaucoma	Drug: brimonidine tartrate/timolol malate Ophthalmic Solution; Drug: bimatoprost ophthalmic solution 0.01%	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Jul 5, 2016
• Actual Primary Completion Date: Jul 25, 2018
• Actual Study Completion Date: Jul 25, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean IOP change from Baseline (11AM point) [Baseline, Month 12]

Secondary Outcome Measures

1. Mean IOP change from Baseline (11AM point) [Baseline, Month 12]

   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%

2. Mean IOP change from Baseline (9AM point) [Baseline, Month 12]

   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%

3. Mean change in Mean deviation (MD) from Baseline [Baseline, Month 12]

4. Mean change in Pattern standard deviation (PSD) from Baseline [Baseline, Month 12]

5. Mean change in Visual field index (VFI) from Baseline [Baseline, Month 12]

6. Mean change in cup to disc ratio (C/D ratio) from Baseline [Baseline, Month 12]

7. Rate of VF progression measured as change in VF index over time [Baseline, Month 12]

   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%

8. Mean duration of achieving the target IOP with COMBIGAN® alone [12 Months]

9. The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months [12 Months]

10. Definition of patient demographics (descriptive analysis of age and gender) [Baseline, Month 12]

    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%

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pusan National University Hospital, Pusan National University School of Medicine	Busan		Korea, Republic of	49241
2	Yeungnam University Hospital, Yeungnam University College of Medicine	Daegu		Korea, Republic of	42415
3	Chungnam National University Hospital, Chungnam National University College of Medicine	Daejeon		Korea, Republic of	35015
4	Chonnam National University Hospital, Chonnam National University Medical School	Gwangju		Korea, Republic of	61469
5	Seoul National University Bundang Hospital, Seoul National University College of Medicine	Gyeonggi-do		Korea, Republic of	13619
6	Seoul National University Hospital, Seoul National University College of Medicine	Seoul		Korea, Republic of	03080
7	Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine	Seoul		Korea, Republic of	03181
8	Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine	Seoul		Korea, Republic of	06591
9	Kim's Eye Hospital, Konyang University College of Medicine	Seoul		Korea, Republic of	07301

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Joy Maglambayan, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT02863705
• Other Study ID Numbers: CMO-AP-EYE-0428
• First Posted: Aug 11, 2016
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Low Tension Glaucoma; Timolol; Brimonidine Tartrate; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Aug 31, 2018