Pooled results of two randomized clinical trials comparing the efficacy and safety of travoprost 0.004%/timolol 0.5% in fixed combination versus concomitant travoprost 0.004% and timolol 0.5%

Figures & data

Figure 1 Comparison of mean IOP for travoprost 0.004%/timolol 0.5% fixed combinaiton and concomitant travoprost 0.004% and timolol 0.5%.

Table 1 Mean IOP comparison for test on non-inferiority

	Baseline			Week 2			Week 6			Month 3
	8 AM	10 AM	4 PM	8 AM	10 AM	4 PM	8 AM	10 AM	4 PM	8 AM	10 AM	4 PM
Trav 0.004%/Tim 0.5%
Mean	25.4	24.0	23.1	16.8	16.2	15.7	16.4	16.2	15.9	16.8	16.3	16.0
N	306	306	306	303	299	300	289	291	286	286	288	286
TRAV+Tim 0.5%
Mean	25.0	23.9	23.0	16.4	15.5	15.1	16.2	15.2	15.1	16.4	15.5	15.2
N	293	293	293	285	282	284	283	281	280	276	273	274
Difference	0.4	0.1	0.1	0.3	0.7	0.6	0.2	1.0	0.8	0.5	0.8	0.8
p-value	0.0438	0.7437	0.7670	0.1490	0.0049	0.0125	0.3874	0.0001	0.0008	0.0651	0.0012	0.0008
Upper 95% CI	0.8	0.5	0.5	0.8	1.2	1.1	0.7	1.5	1.3	0.9	1.3	1.3
Lower 95% CI	0.0	−0.3	−0.3	−0.1	0.2	0.1	−0.3	0.5	0.3	−0.0	0.3	0.3

Notes: Estimates based on least squares means and confidence intervals from repeated measures analysis of variance. Baseline estimates obtained from separate model.

Abbreviations: Trav 0.004%/Tim 0.5%, travoprost 0.004%/timolol 0.5% ophthalmic solution; TRAV +Tim 0.5%, TRAVATAN^® + timolol 0.5% ophthalmic solution.

Table 2 Mean IOP change from baseline comparison for test of non-inferiority

	Baseline			Week 2			Week 6			Month 3
	8 AM	10 AM	4 PM	8 AM	10 AM	4 PM	8 AM	10 AM	4 PM	8 AM	10 AM	4 PM
Trav 0.004%/Tim 0.5%
Mean	25.4	24.0	23.1	−8.6	−7.9	−7.4	−9.0	−7.9	−7.2	−8.6	−7.7	−7.1
N	306	306	306	303	299	300	289	291	286	286	288	286
TRAV+Tim 0.5%
Mean	25.0	23.9	23.0	−8.6	−8.5	−7.9	−8.8	−8.8	−7.9	−8.6	−8.4	−7.9
N	293	293	293	285	282	284	283	281	280	276	273	274
Difference	0.4	0.1	0.1	−0.0	0.6	0.5	−0.2	0.9	0.8	0.0	0.7	0.8
p-value	0.0438	0.7437	0.7670	0.8733	0.0235	0.0550	0.4611	0.0007	0.0042	0.9686	0.0071	0.0047
Upper 95% CI	0.8	0.5	0.5	0.5	1.1	1.0	0.3	1.4	1.3	0.5	1.2	1.3
Lower 95% CI	0.0	−0.3	−0.3	−0.6	0.1	−0.0	−0.7	0.4	0.2	−0.5	0.2	0.2

Notes: Estimates based on least squares means and confidence intervals from repeated measures analysis of variance. Baseline estimates obtained from separate model.

Abbreviations: Trav 0.004%/Tim 0.5%, travoprost 0.004%/timolol 0.5% ophthalmic solution; TRAV + Tim 0.5%, TRAVATAN^® + timolol 0.5% ophthalmic solution.

Table 3 Overall frequency and incidence of adverse events occurring at rates greater than or equal to 1%

	Trav 0.004%/Tim 0.5% n = 322 n (%)	TRAV + Tim 0.5% n = 313 n (%)
Ocular
Hyperemia	44 (13.7)	65 (20.8)
Discomfort	30 (9.3)	31 (9.9)
Dry eye	14 (4.3)	12 (3.8)
Foreign body sensation	13 (4.0)	13 (4.2)
Pruritus	13 (4.0)	17 (5.4)
Decrease in visual acuity	10 (3.1)	12 (3.8)
Pain	8 (2.5)	7 (2.2)
Blurred vision	8 (2.5)	4 (1.3)
Keratitis	7 (2.2)	8 (2.6)
Photophobia	6 (1.9)	6 (1.9)
Corneal staining	6 (1.9)	7 (2.2)
Allergic reaction	4 (1.2)	2 (0.6)
Cells	4 (1.2)	4 (1.3)
Conjunctivitis	4 (1.2)	6 (1.9)
Lid disorder	3 (0.9)	3 (1.0)
Hair disorder	2 (0.6)	8 (2.6)
Tearing	1 (0.3)	4 (1.3)
Subconjunctival hemorrhage	0 (0.0)	4 (1.3)
Non-ocular
Cold syndrome	13 (4.0)	7 (2.2)
Pain	9 (2.8)	3 (1.0)
Infection	8 (2.5)	8 (2.6)
Hypertension	8 (2.5)	16 (5.1)
Bronchitis	7 (2.2)	2 (0.6)
Arthralgia	6 (1.9)	4 (1.3)
Arthritis	6 (1.9)	3 (1.0)
Hypercholesterolemia	5 (1.6)	5 (1.6)
Urinary tract infection	5 (1.6)	0 (0.0)
Sinusitis	4 (1.2)	6 (1.9)
Headache	3 (0.9)	7 (2.2)
Back pain	3 (0.9)	6 (1.9)
Depression	3 (0.9)	3 (1.0)
Rhinitis	3 (0.9)	3 (1.0)
Allergy	2 (0.6)	10 (3.2)
Gastrointestinal disorder	1 (0.3)	4 (1.3)
Cystitis	0 (0.0)	3 (1.0)
Dyspepsia	0 (0.0)	3 (1.0)
Laryngitis	0 (0.0)	3 (1.0)
Malaise	0 (0.0)	3 (1.0)

Notes: List includes both related and not-related adverse events.

Abbreviations: Trav 0.004%/Tim 0.5%, travoprost 0.004%/timolol 0.5% ophthalmic solution; TRAV+Tim 0.5%, TRAVATAN^® + timolol 0.5% ophthalmic solution.