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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863705
Recruitment Status : Completed
First Posted : August 11, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

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

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Study Type : Interventional  (Clinical Trial)
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 : July 5, 2016
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

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




Primary Outcome Measures :
  1. Mean IOP change from Baseline (11AM point) [ Time Frame: Baseline, Month 12 ]

Secondary Outcome Measures :
  1. Mean IOP change from Baseline (11AM point) [ Time Frame: Baseline, Month 12 ]

    Mean IOP change from baseline (11AM point) in the following patient sub-groups

    1. patients with NTG
    2. patients with POAG
    3. patients taking Combigan alone
    4. patients taking Combigan plus additional Lumigan 0.01%

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

    Mean IOP change from baseline (9AM point) in the following patient sub-groups

    1. patients with NTG
    2. patients with POAG
    3. patients taking Combigan alone
    4. patients taking Combigan plus additional Lumigan 0.01%

  3. Mean change in Mean deviation (MD) from Baseline [ Time Frame: Baseline, Month 12 ]
  4. Mean change in Pattern standard deviation (PSD) from Baseline [ Time Frame: Baseline, Month 12 ]
  5. Mean change in Visual field index (VFI) from Baseline [ Time Frame: Baseline, Month 12 ]
  6. Mean change in cup to disc ratio (C/D ratio) from Baseline [ Time Frame: Baseline, Month 12 ]
  7. Rate of VF progression measured as change in VF index over time [ Time Frame: Baseline, Month 12 ]

    Rate of VF progression during 12 months in the following patient sub-groups.

    1. patients with NTG
    2. patients with POAG
    3. patients taking Combigan alone
    4. patients taking Combigan plus additional Lumigan 0.01%

  8. Mean duration of achieving the target IOP with COMBIGAN® alone [ Time Frame: 12 Months ]
  9. The percentage of subjects of achieving the target IOP with COMBIGAN® alone during 12 months [ Time Frame: 12 Months ]
  10. Definition of patient demographics (descriptive analysis of age and gender) [ Time Frame: Baseline, Month 12 ]

    Define patient demographics in the following patient sub-groups:

    1. patients with NTG
    2. patients with POAG
    3. patients taking Combigan alone
    4. patients taking Combigan plus additional Lumigan 0.01%



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863705


Locations
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Korea, Republic of
Pusan National University Hospital, Pusan National University School of Medicine
Busan, Korea, Republic of, 49241
Yeungnam University Hospital, Yeungnam University College of Medicine
Daegu, Korea, Republic of, 42415
Chungnam National University Hospital, Chungnam National University College of Medicine
Daejeon, Korea, Republic of, 35015
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, Korea, Republic of, 61469
Seoul National University Bundang Hospital, Seoul National University College of Medicine
Gyeonggi-do, Korea, Republic of, 13619
Seoul National University Hospital, Seoul National University College of Medicine
Seoul, Korea, Republic of, 03080
Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, Korea, Republic of, 03181
Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine
Seoul, Korea, Republic of, 06591
Kim's Eye Hospital, Konyang University College of Medicine
Seoul, Korea, Republic of, 07301
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Joy Maglambayan Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02863705    
Other Study ID Numbers: CMO-AP-EYE-0428
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases
Timolol
Brimonidine Tartrate
Bimatoprost
Pharmaceutical Solutions
Ophthalmic Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists