NCT02863705

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2016

Typical duration for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

May 2, 2016

Last Update Submit

August 28, 2018

Conditions

Glaucoma, Open-AngleNormal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Mean IOP change from Baseline (11AM point)

    Baseline, Month 12

Secondary Outcomes (10)

  • Mean IOP change from Baseline (11AM point)

    Baseline, Month 12

  • Mean IOP change from Baseline (9AM point)

    Baseline, Month 12

  • Mean change in Mean deviation (MD) from Baseline

    Baseline, Month 12

  • Mean change in Pattern standard deviation (PSD) from Baseline

    Baseline, Month 12

  • Mean change in Visual field index (VFI) from Baseline

    Baseline, Month 12

  • +5 more secondary outcomes

Study Arms (2)

COMBIGAN®

EXPERIMENTAL

One drop of COMBIGAN® in the affected eye, administered twice daily for 12 months

Drug: brimonidine tartrate/timolol malate Ophthalmic Solution

COMBIGAN® + LUMIGAN® 0.01%

EXPERIMENTAL

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 SolutionDrug: bimatoprost ophthalmic solution 0.01%

Interventions

brimonidine tartrate/timolol malate Ophthalmic SolutionDRUG

One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months

COMBIGAN®COMBIGAN® + LUMIGAN® 0.01%
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

COMBIGAN® + LUMIGAN® 0.01%

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with Primary open angle glaucoma (Regardless of Intraocular pressure)
  • Previous history of topical beta-blocker use and insufficiently controlled IOP

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pusan National University Hospital, Pusan National University School of Medicine

Busan, 49241, South Korea

Location

Yeungnam University Hospital, Yeungnam University College of Medicine

Daegu, 42415, South Korea

Location

Chungnam National University Hospital, Chungnam National University College of Medicine

Daejeon, 35015, South Korea

Location

Chonnam National University Hospital, Chonnam National University Medical School

Gwangju, 61469, South Korea

Location

Seoul National University Bundang Hospital, Seoul National University College of Medicine

Gyeonggi-do, 13619, South Korea

Location

Seoul National University Hospital, Seoul National University College of Medicine

Seoul, 03080, South Korea

Location

Kangbuk Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, 03181, South Korea

Location

Seoul St. Mary's Hospital, The Catholic University of Korea College of Medicine

Seoul, 06591, South Korea

Location

Kim's Eye Hospital, Konyang University College of Medicine

Seoul, 07301, South Korea

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleLow Tension Glaucoma

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Joy Maglambayan

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2016

First Posted

August 11, 2016

Study Start

July 5, 2016

Primary Completion

July 25, 2018

Study Completion

July 25, 2018

Last Updated

August 31, 2018

Record last verified: 2018-08

Locations

KR(9)