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

NCT02863705 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2018-08-31

No results posted yet for this study

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%.

Conditions

  • Glaucoma, Open-Angle
  • Normal Tension Glaucoma

Interventions

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

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Joy Maglambayan · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-05
Primary Completion
2018-07-25
Completion
2018-07-25

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02863705 on ClinicalTrials.gov