Trial Outcomes & Findings for A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy (NCT NCT01637246)

NCT ID: NCT01637246

Last Updated: 2012-09-21

Results Overview

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

• Recruitment status: COMPLETED
• Target enrollment: 4385 participants
• Primary outcome timeframe: Baseline, 12 Weeks
• Results posted on: 2012-09-21

Participant Flow

Participant milestones

Measure	POAG or OHT Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Overall Study STARTED	4385
Overall Study COMPLETED	2246
Overall Study NOT COMPLETED	2139

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Patients With Primary Open Angle Glaucoma or Ocular Hypertension Who Were Insufficiently Responsive to Monotherapy

Baseline characteristics by cohort

Measure	POAG or OHT n=4385 Participants Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Age Continuous Data Available (N=2234)	66.69 Years STANDARD_DEVIATION 11.43 • n=5 Participants
Age Continuous Missing Data (N=2151)	NA Years STANDARD_DEVIATION NA • n=5 Participants
Sex/Gender, Customized Female	1177 Participants n=5 Participants
Sex/Gender, Customized Male	1111 Participants n=5 Participants
Sex/Gender, Customized Missing Data	2097 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 Weeks

Population: All patients who met the study entry criteria and have data for this outcome measure

IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement.

Outcome measures

Measure	POAG or OHT n=2286 Participants Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Change From Baseline in Intraocular Pressure (IOP) Change from Baseline at 12 Wks-Lft Eye (N=2192)	-4.88 Millimeters of Mercury (mmHg) Standard Deviation 3.27
Change From Baseline in Intraocular Pressure (IOP) Baseline - Right Eye (N=2286)	21.72 Millimeters of Mercury (mmHg) Standard Deviation 3.62
Change From Baseline in Intraocular Pressure (IOP) Change from Baseline at 12 Wks-Rt Eye (N=2235)	-4.93 Millimeters of Mercury (mmHg) Standard Deviation 3.24
Change From Baseline in Intraocular Pressure (IOP) Baseline - Left Eye (N=2248)	21.59 Millimeters of Mercury (mmHg) Standard Deviation 3.61

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients who met the study entry criteria and have data for this outcome measure

Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.

Outcome measures

Measure	POAG or OHT n=2244 Participants Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Patient Assessment of Tolerability Using a 4-Point Scale	79.2 Percentage of Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients who met the study entry criteria and have data for this outcome measure

Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The percentage of patients assessed as good and very good combined are reported.

Outcome measures

Measure	POAG or OHT n=2307 Participants Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Physician Assessment of Tolerability Using a 4-Point Scale	87.6 Percentage of Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients who met the study entry criteria and have data for this outcome measure

Percentage of patients who maintained better compliance with treatment than prior therapy was assessed by the patient on a 3-point scale (better, equal, and worse compliance).

Outcome measures

Measure	POAG or OHT n=2263 Participants Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Percentage of Patients Who Maintained Better Compliance With Treatment	33.5 Percentage of Patients

SECONDARY outcome

Timeframe: 12 Weeks

Population: All patients who met the study entry criteria and have data for this outcome measure

Percentage of patients continuing on therapy after 12 weeks was assessed as Yes or No.

Outcome measures

Measure	POAG or OHT n=2265 Participants Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Percentage of Patients Continuing on Therapy After 12 Weeks	92.9 Percentage of Patients

Adverse Events

POAG or OHT

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	POAG or OHT n=4385 participants at risk Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.02% 1/4385
Eye disorders Keratitis	0.05% 2/4385
Eye disorders Keratitis Herpetic	0.02% 1/4385

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place