Trial Outcomes & Findings for A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) (NCT NCT01628614)

Results Overview

Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.

Recruitment status

COMPLETED

Target enrollment

4812 participants

Primary outcome timeframe

Baseline, 14 Weeks

Results posted on

2012-09-05

Participant Flow

Participant milestones

Participant milestones
Measure	POAG or OHT Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Overall Study STARTED	4812
Overall Study COMPLETED	3037
Overall Study NOT COMPLETED	1775

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Intraocular Pressure (IOP) Reduction in Newly Diagnosed Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	POAG or OHT n=4812 Participants Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Age Continuous Evaluable (N=2647 patients)	64.72 Years STANDARD_DEVIATION 12.03 • n=5 Participants
Age Continuous Missing (N=2165 patients)	NA Years STANDARD_DEVIATION NA • n=5 Participants
Sex/Gender, Customized Female	1642 Participants n=5 Participants
Sex/Gender, Customized Male	1389 Participants n=5 Participants
Sex/Gender, Customized Missing	1781 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 14 Weeks

Population: Evaluable Patients: all patients who met the study entry criteria

Percentage of patients with a reduction in IOP≥5 mmHg from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 5 mmHg was evaluated in the eye with the highest pressure at the baseline visit.

Outcome measures

Outcome measures
Measure	POAG or OHT n=3037 Participants Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Percentage of Patients With a Reduction in Intraocular Pressure (IOP) ≥ 5mmHg From Baseline	75.9 Millimeters of Mercury (mmHg)

SECONDARY outcome

Timeframe: Baseline, 14 Weeks

Population: Evaluable Patients: all patients who met the study entry criteria

Percentage of patients with an IOP reduction ≥10% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 10% was evaluated in the eye with the highest pressure at the baseline visit.

Outcome measures

Outcome measures
Measure	POAG or OHT n=3037 Participants Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Percentage of Patients With an IOP Reduction ≥10% From Baseline	91.0 Percentage of Patients

SECONDARY outcome

Timeframe: Baseline, 14 Weeks

Population: Evaluable Patients: all patients who met the study entry criteria

Percentage of patients with an IOP reduction ≥20% from baseline. IOP is a measurement of the fluid pressure inside the eye. The minimum reduction of 20% was evaluated in the eye with the highest pressure at the baseline visit.

Outcome measures

Outcome measures
Measure	POAG or OHT n=3037 Participants Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Percentage of Patients With an IOP Reduction ≥20% From Baseline	70.8 Percentage of Patients

Adverse Events

POAG or OHT

Serious events: 0 serious events

Other events: 180 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	POAG or OHT n=3037 participants at risk Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
Eye disorders Ocular Hyperaemia	5.9% 180/3037 SAEs and AEs were analyzed for evaluable patients.

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place