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OpenTrials
Completed

NCT Number: NCT02863705

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%.

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Key information

Conditions

Glaucoma, Open-Angle Eye Diseases Glaucoma Low Tension Glaucoma Normal Tension Glaucoma Ocular Hypertension Optic Nerve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pusan National University Hospital, Pusan National University School of Medicine, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

brimonidine tartrate/timolol malate Ophthalmic Solution

Drug

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%

Drug

Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed

Primary outcomes

  1. Mean IOP change from Baseline (11AM point)

    Time frame: Baseline, Month 12

Secondary outcomes

  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

    • 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)

    Time frame: 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

    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.

    • 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

    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:

    • patients with NTG
    • patients with POAG
    • patients taking Combigan alone
    • patients taking Combigan plus additional Lumigan 0.01%

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2016
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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