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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01999348
Other study ID # MAF/AGN/OPH/GLA/039
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 25, 2013
Est. completion date December 19, 2014

Study information

Verified date April 2019
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1553
Est. completion date December 19, 2014
Est. primary completion date December 19, 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Diagnosed with primary open-angle glaucoma or ocular hypertension

- Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

Exclusion Criteria:

Study Design


Intervention

Drug:
Fixed Combination Bimatoprost and Timolol
Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Pfennigsdorf S, Eschstruth P, Häsemeyer S, Feuerhake C, Brief G, Grobeiu I, Shirlaw A. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice. Clin Ophthalmol. 2016 Sep 20;10:1837-1846. eCollection 2016. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline in Intraocular Pressure (IOP) in the Study Eye 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, Final Visit (Week 8 to 12)
Secondary Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale 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. Baseline, Final Visit (Week 8 to 12)
Secondary Patient Assessment of Tolerability on a 4-Point Scale 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. Final Visit (Week 8 to 12)
Secondary Physician Assessment of Tolerability on a 4-Point Scale 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. Final Visit (Week 8 to 12)
Secondary Percentage of Patients Who Discontinued Treatment The percentage of participants who discontinued treatment with Ganfort® UD up to the Week 12 Final Visit 12 Weeks
Secondary Percentage of Patients Prescribed by the Physician to Continue Treatment The percentage of participants who continued treatment with Ganfort® UD after Week 12. Final Visit (Week 8 to 12)
Secondary Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale 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. Final Visit (Week 8 to 12)
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