Safety and Efficacy of Bimatoprost/Timolol Fixed Combination Versus Latanoprost in Patients With Open-Angle Glaucoma Who Have Never Been Treated

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01243567

Enrollment

Registered

2010-11-18

Start date

2010-06-01

Completion date

2012-02-14

Last updated

2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Open-Angle

Brief summary

This study will evaluate the safety and efficacy of bimatoprost/timolol fixed combination (GANfort®) versus latanoprost (Xalatan®) in patients with open-angle glaucoma who have never been previously treated and are at high risk for progression.

Interventions

DRUGbimatoprost 0.03%/timolol 0.5% combination ophthalmic solution

Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.

DRUGlatanoprost 0.005% ophthalmic solution

Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of primary open-angle glaucoma that has never been treated * Visual Acuity 20/60 or better in each eye

Exclusion criteria

* Eye surgery within 3 months * Any refractive eye surgery * Contraindication to beta-adrenoceptor antagonist therapy (eg, chronic obstructive pulmonary disease \[COPD\], bronchial asthma, sinus bradycardia, heart block, history of severe myocardial infarction \[heart attack\]) * Eye inflammation or eye infection within 3 months * Eye trauma within 6 months * Oral, injectable, or topical ophthalmic steroids within 21 days or anticipated use during study

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Average Intraocular Pressure (IOP)	Baseline, Month 3	IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).

Secondary

Measure	Time frame	Description
Change From Baseline IOP	Baseline, Month 3	IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. IOP is recorded at the 08:00 (8:00 am), 12:00 (noon) and 16:00 (4:00 pm) hour time points for each patient at each visit. A negative number change from Baseline indicates a reduction in IOP (improvement).
Percentage of Patients Reaching a Predefined Target Pressure Threshold	Baseline, Month 3	IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The predefined target pressure thresholds are at least a 20%, 30%, 40%, and 50% reduction in IOP from baseline.
Absolute Difference Between Patient's Highest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading	Baseline, Month 3	IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The highest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.
Absolute Difference Between Patient's Lowest IOP Reading at Baseline (Day 0) and the Corresponding IOP Reading	Baseline, Month 3	IOP is a measurement of the fluid pressure inside the eye. Two or three measurements of IOP are taken for each eye at each time point. The lowest IOP values between the two eyes for each patient at each time point are used to calculate the absolute difference.

Countries

Portugal, Spain

Participant flow

Participants by arm

Arm	Count
Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.	43
Latanoprost 0.005% Ophthalmic Solution Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.	38
Total	81

Baseline characteristics

Characteristic	Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution	Latanoprost 0.005% Ophthalmic Solution	Total
Age, Continuous	65.9 Years STANDARD_DEVIATION 10.24	63.1 Years STANDARD_DEVIATION 13.72	64.6 Years STANDARD_DEVIATION 12.01
Sex: Female, Male Female	20 Participants	18 Participants	38 Participants
Sex: Female, Male Male	23 Participants	20 Participants	43 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	9 / 43	10 / 38
serious Total, serious adverse events	1 / 43	0 / 38

Outcome results

Primary

Change From Baseline in Average Intraocular Pressure (IOP)

IOP is a measurement of the fluid pressure inside the eye. For each patient, the IOP is the average of the two eyes. The average IOP is the average of the 08:00, 12:00 and 16:00 hour time points at each visit for each patient. A negative number change from Baseline indicates a reduction in average IOP (improvement).

Time frame: Baseline, Month 3