NCT01999348

A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting

Completed Results posted Last updated 19 April 2019

What this trial tests

trial testing Fixed Combination Bimatoprost and Timolol in Glaucoma, Primary Open Angle in 1,553 participants. Completed in 19 December 2014.

Timeline

25 November 2013

Primary endpoint
19 December 2014

19 December 2014

Quick facts

Lead sponsor	Allergan
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,553
Start date	25 November 2013
Primary completion	19 December 2014
Estimated completion	19 December 2014
Sites	1 location across Germany

Drugs / interventions tested

• Fixed Combination Bimatoprost and Timolol — full drug profile →

Conditions studied

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

Sponsor

Allergan — full company profile →

Who can join

Eligibility, any sex, with Glaucoma, Primary 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 Study Eye Primary · Baseline, Final Visit (Week 8 to 12)

IOP is a measure of the fluid pressure inside the study eye. A result at the Final Visit that is lower than the result at Baseline indicates a reduction in IOP (improvement).

Baseline

Group	Value	95% CI
Patients With POAG or OHT	22.18	± 3.55

Final Visit

Group	Value	95% CI
Patients With POAG or OHT	16.11	± 2.87

Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale Secondary · Baseline, Final Visit (Week 8 to 12)

The physician assessed the effectiveness of Ganfort® UD with regard to IOP changes from Baseline using a 3-point scale where: 1=Better than expected (best), 2=As expected and 3=Worse than expected. The number of participants in each category is reported.

Better than expected

Group	Value	95% CI
Patients With POAG or OHT	497

As expected

Group	Value	95% CI
Patients With POAG or OHT	729

Worse than expected

Group	Value	95% CI
Patients With POAG or OHT	98

Missing data

Group	Value	95% CI
Patients With POAG or OHT	67

Patient Assessment of Tolerability on a 4-Point Scale Secondary · Final Visit (Week 8 to 12)

The patient assessed the tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.

Very good

Group	Value	95% CI
Patients With POAG or OHT	788

Good

Group	Value	95% CI
Patients With POAG or OHT	461

Moderate

Group	Value	95% CI
Patients With POAG or OHT	45

Poor

Group	Value	95% CI
Patients With POAG or OHT	50

Missing

Group	Value	95% CI
Patients With POAG or OHT	47

Physician Assessment of Tolerability on a 4-Point Scale Secondary · Final Visit (Week 8 to 12)

The physician assessed the patient's tolerability of Ganfort® UD using a 4-point scale where: 1=very good (best), 2=good, 3=moderate and 4=poor. The number of participants in each category is reported.

Very good

Group	Value	95% CI
Patients With POAG or OHT	809

Good

Group	Value	95% CI
Patients With POAG or OHT	474

Moderate

Group	Value	95% CI
Patients With POAG or OHT	40

Poor

Group	Value	95% CI
Patients With POAG or OHT	28

Missing

Group	Value	95% CI
Patients With POAG or OHT	40

Percentage of Patients Who Discontinued Treatment Secondary · 12 Weeks

The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit

Group	Value	95% CI
Patients With POAG or OHT	6.47

Percentage of Patients Prescribed by the Physician to Continue Treatment Secondary · Final Visit (Week 8 to 12)

The percentage of participants who continued treatment with Ganfort® UD after Week 12.

Group	Value	95% CI
Patients With POAG or OHT	89.14

Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale Secondary · Final Visit (Week 8 to 12)

The physician assessed patient compliance with Ganfort® UD compared to previous treatment using a 3-point scale where: 1=better (best), 2=equal and 3=worse. The number of participants in each category is reported.

Better

Group	Value	95% CI
Patients With POAG or OHT	727

Equal

Group	Value	95% CI
Patients With POAG or OHT	542

Worse

Group	Value	95% CI
Patients With POAG or OHT	34

Missing

Group	Value	95% CI
Patients With POAG or OHT	49

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 12 Weeks. 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: 1/1553 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Patients With POAG or OHT
Death	General disorders	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT01999348 adverse events section.

Sponsor's own description

The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.

Publications & conference data

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

1. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice.
   Pfennigsdorf S, Eschstruth P, Häsemeyer S, Feuerhake C, et al · · 2016 · cited 4× · PMID 27703324 · DOI 10.2147/opth.s106159