NCT01735214

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

Completed Results posted Last updated 18 April 2019

What this trial tests

trial testing Prostaglandin Analogue -Containing IOP-Lowering Therapy in Glaucoma, Open-Angle in 358 participants. Completed in 10 April 2014.

Timeline

7 March 2013

Primary endpoint
10 April 2014

10 April 2014

Quick facts

Lead sponsor	Allergan
Status	Completed
Study type	OBSERVATIONAL
Enrollment	358
Start date	7 March 2013
Primary completion	10 April 2014
Estimated completion	10 April 2014
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Prostaglandin Analogue -Containing IOP-Lowering Therapy — full drug profile →

Conditions studied

• Glaucoma, Open-Angle — all drugs for Glaucoma, Open-Angle →
• Ocular Hypertension — all drugs for Ocular Hypertension →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Glaucoma, Open-Angle or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Intraocular Pressure (IOP) in the Right Eye Primary · Baseline, Week 12

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

Group	Value	95% CI
Patients With POAG or OHT	-4.5	± 4.6

Patient Assessment of Overall Tolerability With New Treatment Using a 4-Point Scale Secondary · 12 Weeks

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.

Very good

Group	Value	95% CI
Patients With POAG or OHT	48.6

Good

Group	Value	95% CI
Patients With POAG or OHT	31.6

Moderate

Group	Value	95% CI
Patients With POAG or OHT	6.1

Poor

Group	Value	95% CI
Patients With POAG or OHT	1.7

Missing data

Group	Value	95% CI
Patients With POAG or OHT	12.0

Physician Assessment of Tolerability With New Treatment Using a 4-Point Scale Secondary · 12 Weeks

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.

Very good

Group	Value	95% CI
Patients With POAG or OHT	50.0

Good

Group	Value	95% CI
Patients With POAG or OHT	33.0

Moderate

Group	Value	95% CI
Patients With POAG or OHT	4.7

Poor

Group	Value	95% CI
Patients With POAG or OHT	2.2

Missing data

Group	Value	95% CI
Patients With POAG or OHT	10.1

Percentage of Participants Who Discontinue the Use of New Treatment Prior to 12 Weeks Secondary · 12 Weeks

Group	Value	95% CI
Patients With POAG or OHT	7.5

Percentage of Participants Who Continue the New Treatment After 12 Weeks Secondary · 12 Weeks

Group	Value	95% CI
Patients With POAG or OHT	83.5

Physician Assessment of Adherence to New Treatment Using a 4-Point Scale Secondary · 12 Weeks

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.

Not Applicable

Group	Value	95% CI
Patients With POAG or OHT	1.68

Worse

Group	Value	95% CI
Patients With POAG or OHT	4.47

Equal

Group	Value	95% CI
Patients With POAG or OHT	42.74

Better

Group	Value	95% CI
Patients With POAG or OHT	41.34

Missing data

Group	Value	95% CI
Patients With POAG or OHT	9.78

Physician Assessment of Efficacy Using a 5-Point Scale Secondary · 12 Weeks

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.

IOP lower than target

Group	Value	95% CI
Patients With POAG or OHT	24.0

Reached target IOP

Group	Value	95% CI
Patients With POAG or OHT	49.7

IOP decreased but target NOT reached

Group	Value	95% CI
Patients With POAG or OHT	10.9

No change

Group	Value	95% CI
Patients With POAG or OHT	0.8

IOP increased

Group	Value	95% CI
Patients With POAG or OHT	4.7

Missing data

Group	Value	95% CI
Patients With POAG or OHT	9.8

Percentage of Participants Reaching Individual IOP Target After 12 Weeks Secondary · 12 Weeks

Group	Value	95% CI
Patients With POAG or OHT	49.7

Change From Baseline in Intraocular Pressure (IOP) in the Left Eye Primary · Baseline, Week 12

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

Group	Value	95% CI
Patients With POAG or OHT	-4.2	± 5.0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With POAG or OHT

Serious: 0/358 (0%)

Deaths: —

Other adverse events (1 terms — click to expand)

Reaction	System	Patients With POAG or OHT
Conjunctival hyperemia	Eye disorders	—

Data from ClinicalTrials.gov NCT01735214 adverse events section.

Sponsor's own description

This study is a prospective, observational study of changing from any IOP-lowering treatment to a prostaglandin analogue-containing IOP-lowering medication for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT). The decision to change medications lies with the physician according to their standard practice.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prospective, non-interventional, multicenter study of the intraocular pressure-lowering effects of prostaglandin analog/prostamide-containing therapies in previously treated patients with open-angle glaucoma or ocular hypertension.
   Tamçelik N, Izgi B, Temel A, Yildirim N, et al · · 2017 · cited 2× · PMID 28458511 · DOI 10.2147/opth.s119963