Trial Outcomes & Findings for Safety and Efficacy of Bimatoprost/Timolol (Ganfort®) Ophthalmic Solution in Korea (NCT NCT01976624)

NCT ID: NCT01976624

Last Updated: 2015-09-28

Results Overview

An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

• Recruitment status: COMPLETED
• Target enrollment: 756 participants
• Primary outcome timeframe: Up to 51 months
• Results posted on: 2015-09-28

Participant Flow

Participant milestones

Measure	Ganfort® Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Overall Study STARTED	756
Overall Study COMPLETED	742
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Ganfort® Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Overall Study Participants contraindicated	2
Overall Study Participants age less than 19 years	12

Baseline Characteristics

Safety and Efficacy of Bimatoprost/Timolol (Ganfort®) Ophthalmic Solution in Korea

Baseline characteristics by cohort

Measure	Ganfort® n=742 Participants Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Age, Customized 18 to <30 years	23 participants n=5 Participants
Age, Customized 30 to 39 years	67 participants n=5 Participants
Age, Customized 40 to 49 years	91 participants n=5 Participants
Age, Customized 50 to 59 years	167 participants n=5 Participants
Age, Customized 60 to 69 years	196 participants n=5 Participants
Age, Customized 70 to 79 years	151 participants n=5 Participants
Age, Customized ≥80 years	46 participants n=5 Participants
Age, Customized Data not Available	1 participants n=5 Participants
Sex: Female, Male Female	316 Participants n=5 Participants
Sex: Female, Male Male	426 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 51 months

Population: Safety population included all participants treated for on-label indications.

An Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.

Outcome measures

Measure	Ganfort® n=742 Participants Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Number of Participants With Adverse Events and Adverse Drug Reactions Adverse Events	146 participants
Number of Participants With Adverse Events and Adverse Drug Reactions Adverse Drug Reactions	134 participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Efficacy population included all participants who were treated for on-label indications with data available for analysis.

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicated an improvement. The median total treatment duration for participants was 63.0 days.

Outcome measures

Measure	Ganfort® n=641 Participants Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Change From Baseline in Intraocular Pressure (IOP) Right Eye: Baseline (n=608)	18.23 mmHg Standard Deviation 6.69
Change From Baseline in Intraocular Pressure (IOP) Right Eye: Change from Baseline (n=608)	-3.28 mmHg Standard Deviation 5.32
Change From Baseline in Intraocular Pressure (IOP) Left Eye: Baseline (n=616)	18.23 mmHg Standard Deviation 6.48
Change From Baseline in Intraocular Pressure (IOP) Left Eye: Change from Baseline (n=616)	-3.50 mmHg Standard Deviation 5.24

Adverse Events

Ganfort®

Serious events: 1 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ganfort® n=742 participants at risk Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm metastatic	0.13% 1/742 The Safety Population, all participants treated for on-label indications, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.

Other adverse events

Measure	Ganfort® n=742 participants at risk Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
Eye disorders Conjunctival hyperaemia	11.6% 86/742 The Safety Population, all participants treated for on-label indications, was used to determine the number of participants at risk for Serious Adverse Events and Adverse Events.

Additional Information

Vice President GSE,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is at least 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER