Trial Outcomes & Findings for An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments (NCT NCT01735214)

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

358 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2019-04-18

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With POAG or OHT Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Overall Study STARTED	358
Overall Study COMPLETED	358
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) Who Switched IOP-lowering Treatments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Age, Customized 18 to 30 years	10 participants n=5 Participants
Age, Customized 31 to 40 years	9 participants n=5 Participants
Age, Customized 41 to 50 years	28 participants n=5 Participants
Age, Customized 51 to 60 years	89 participants n=5 Participants
Age, Customized 61 to 70 years	125 participants n=5 Participants
Age, Customized 71 to 80 years	81 participants n=5 Participants
Age, Customized 81 to 90 years	16 participants n=5 Participants
Sex: Female, Male Female	180 Participants n=5 Participants
Sex: Female, Male Male	178 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All participant with IOP data at Baseline and Week 12 for analysis.

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

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=312 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Change From Baseline in Intraocular Pressure (IOP) in the Right Eye	-4.5 mmHg Standard Deviation 4.6

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: All participant with IOP data at Baseline and Week 12 for analysis.

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

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=315 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Change From Baseline in Intraocular Pressure (IOP) in the Left Eye	-4.2 mmHg Standard Deviation 5.0

SECONDARY outcome

Timeframe: 12 Weeks

Population: All participants with available data.

The patient evaluated the tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale Very good	48.6 percentage of participants
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale Good	31.6 percentage of participants
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale Moderate	6.1 percentage of participants
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale Poor	1.7 percentage of participants
Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale Missing data	12.0 percentage of participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: All participants with data available for analysis.

The physician evaluated the patient's tolerability of IOP-lowering medication therapy using a 4-Point Scale: Very good, Good, Moderate or Poor. Percentage of participants in each category is reported.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale Very good	50.0 percentage of participants
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale Good	33.0 percentage of participants
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale Moderate	4.7 percentage of participants
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale Poor	2.2 percentage of participants
Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale Missing data	10.1 percentage of participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: All participants.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks	7.5 percentage of participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: All participants

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Percentage of Participants Who Continue the New Treatment After 12 Weeks	83.5 percentage of participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: All Participants

The physician assessed the participant's adherence to new treatment using the following scale: Not Applicable, Worse, Equal or Better. The percentage of participants in each category is reported.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale Not Applicable	1.68 percentage of participants
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale Worse	4.47 percentage of participants
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale Equal	42.74 percentage of participants
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale Better	41.34 percentage of participants
Physician Assessment of Adherence to New Treatment Using a 4-Point Scale Missing data	9.78 percentage of participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: All participants.

The physician evaluated efficacy (IOP lowering) using a 5-Point Scale: IOP lower than target, Reached Target IOP, IOP decreased but target not reached, No change or IOP increased. The percentage of participants in each category is reported.

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Physician Assessment of Efficacy Using a 5-Point Scale IOP lower than target	24.0 percentage of participants
Physician Assessment of Efficacy Using a 5-Point Scale Reached target IOP	49.7 percentage of participants
Physician Assessment of Efficacy Using a 5-Point Scale IOP decreased but target NOT reached	10.9 percentage of participants
Physician Assessment of Efficacy Using a 5-Point Scale No change	0.8 percentage of participants
Physician Assessment of Efficacy Using a 5-Point Scale IOP increased	4.7 percentage of participants
Physician Assessment of Efficacy Using a 5-Point Scale Missing data	9.8 percentage of participants

SECONDARY outcome

Timeframe: 12 Weeks

Population: All participants

Outcome measures

Outcome measures
Measure	Patients With POAG or OHT n=358 Participants Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Percentage of Participants Reaching Individual IOP Target After 12 Weeks	49.7 percentage of participants

Adverse Events

Patients With POAG or OHT

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients With POAG or OHT n=358 participants at risk Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
Eye disorders Conjunctival hyperemia	6.4% 23/358

Additional Information

Vice President Medical Affairs,

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