A randomized clinical trial comparing three fixed combinations of bimatoprost with timolol in patients with open-angle glaucoma or ocular hypertension

Figures & data

Figure 1. Flow chart of patient disposition. Abbreviations. ITT, intent-to-treat; mITT, modified intent-to-treat; PP, perprotocol; PK, pharmacokinetics. A one patient performed screening visit but withdrew from the study before the randomisation visit due to abnormal ECG. The patient was considered a screen failure but was randomised incorrectly in the Ganfort group. As only the screening visit was performed, the patient was excluded from the study. Consequently, the total number of patients considered in the study was 86.

Table 1. Demographic and other characteristics at Screening (mITT set).

Screening characteristics	T4030a (N = 29)	T4030c (N = 29)	Ganfort (N = 28)	Total (N = 86)
Age (mean ± SD) (years)	61.4 ± 11.1	64.1 ± 7.8	59.2 ± 13.1	61.6 ± 10.9
Gender [n (%)]
Male	9 (31.0)	7 (24.1)	11 (39.3)	27 (31.4)
Female	20 (69.0)	22 (75.9)	17 (60.7)	59 (68.6)
Diagnosis [n (%)]
Primary open angle glaucoma	24 (82.8)	23 (79.3)	23 (82.1)	70 (81.4)
Ocular hypertension	4 (13.8)	4 (13.8)	3 (10.7)	11 (12.8)
Secondary open angle glaucoma: exfoliation glaucoma			1 (3.6)	1 (1.2)
Secondary open angle glaucoma: pigmentary glaucoma	1 (3.4)	2 (6.9)	1 (3.6)	4 (4.7)
Time to diagnosis (median) (months)	64.2	132.0	70.9	83.8
Ocular biometry parameters
Central corneal thickness (µm) (mean ± SD)	547.7 ± 30.8	538.2 ± 27.5	553.6 ± 28.4	546.4 ± 29.3
Fundoscopy (C/D ratio) (mean ± SD)	0.46 ± 0.20	0.50 ± 0.22	0.45 ± 0.22	0.47 ± 0.21
Previous treatment type [n (%)
Monotherapy	11 (37.9)	11 (37.9)	10 (35.7)	32 (37.2)
Dual therapy	18 (62.1)	18 (62.1)	18 (64.3)	54 (62.8)
Intraocular pressure (mean ± SD) (mmHg)	16.48 ± 2.84	17.24 ± 2.91	17.29 ± 2.89	17.00 ± 2.87

Abbreviation. SD, standard deviation.

Table 2. IOP (mmHg) in the worse eye at baseline (day 1; 08:00), week 6 and week 12 (primary efficacy analysis) and change from baseline (mITT Set).

Table 3. Summary of AEs related to treatment (Safety set).

	System organ class	T4030a	T4030c	Ganfort
	Preferred term	(N = 29)	(N = 29)	(N = 28)
Ocular AEs	Eye disorders	4 (13.8%)	5 (17.2%)	6 (21.4%)
	Blepharitis	1 (3.4%)	–	1 (3.6%)
	Erythema of eyelid	1 (3.4%)	1 (3.4%)	–
	Eye allergy	–	1 (3.4%)	–
	Eye irritation	1 (3.4%)	1 (3.4%)	–
	Eye pruritus	1 (3.4%)	–	1 (3.6%)
	Eye symptom	–	–	1 (3.6%)
	Eyelids pruritus	–	–	1 (3.6%)
	Vision blurred	–	2 (6.9%)	–
	Injury, poisoning and procedural complications	–	–	1 (3.6%)
	Documented hypersensitivity to administered product	–	–	1 (3.6%)
	Investigations	1 (3.4%)	1 (3.4%)	–
	Vital dye staining cornea present	1 (3.4%)	1 (3.4%)	–
Systemic AEs	Nervous system disorders	–	–	1 (3.6%)
	Headache	–	–	1 (3.6%)

System organ class and preferred term coding according to the Medical Dictionary for Regulatory Activities Version 21.1 (May 2020).

Data are number of patients (%) with at least one treatment-related AE.

Figure 2. Timolol plasma concentration (AUC 0-12 h, ng/mL) at Baseline and Week 12 for T4030a, T4030c and Ganfort groups (PK set).