Trial Outcomes & Findings for Safety and Efficacy of Combigan® Ophthalmic Solution in Korea (NCT NCT01987752)

Results Overview

An adverse event was 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.

Recruitment status

COMPLETED

Target enrollment

732 participants

Primary outcome timeframe

Up to 2.6 Years

Results posted on

2014-04-04

Participant Flow

Participant milestones

Participant milestones
Measure	Combigan® Ophthalmic Solution Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Overall Study STARTED	732
Overall Study COMPLETED	732
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Efficacy of Combigan® Ophthalmic Solution in Korea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combigan® Ophthalmic Solution n=732 Participants Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Age, Customized < 50 years	140 Participants n=5 Participants
Age, Customized 50 - 59 years	144 Participants n=5 Participants
Age, Customized 60 - 69 years	219 Participants n=5 Participants
Age, Customized ≥ 70 years	225 Participants n=5 Participants
Age, Customized Missing Data	4 Participants n=5 Participants
Sex/Gender, Customized Female	347 Participants n=5 Participants
Sex/Gender, Customized Male	384 Participants n=5 Participants
Sex/Gender, Customized Missing Data	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2.6 Years

Population: Safety Population included all participants who received study drug.

An adverse event was 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.

Outcome measures

Outcome measures
Measure	Combigan® Ophthalmic Solution n=732 Participants Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Percentage of Participants Reporting Adverse Events	6.56 Percentage of participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Efficacy Population included all participants who received study drug for \> 4 weeks and had overall assessment data available.

IOP is a measurement of the fluid pressure inside the eye. The study doctor classified the overall improvement of the IOP change from Baseline into 3 categories: Improvement (effective), No Change or Exacerbation (ineffective). The percentage of participants with Improvement is reported.

Outcome measures

Outcome measures
Measure	Combigan® Ophthalmic Solution n=699 Participants Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)	85.69 Percentage of participants

Adverse Events

Combigan® Ophthalmic Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vice President GSE,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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 less than or equal to 90 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