Clinical Study

Efficacy and Tolerability of Travoprost 0.004/Timolol 0.5 Fixed-Dose Combination for the Treatment of Primary Open-Angle Glaucoma or Ocular Hypertension Inadequately Controlled with Beta-Blocker Monotherapy

Table 3

Incidence of treatment-related TEAEs during the study (safety population).

MedDRA preferred termTTFC
()
Beta-blocker
()

Eye disorders, n (%)12 (14.8)3 (4.0)
Ocular hyperemia5 (6.2)0
Ocular pruritus3 (3.7)0
Conjunctivitis allergic1 (1.2)1 (1.3)
Dry eye1 (1.2)1 (1.3)
Ocular surface disease1 (1.2)1 (1.3)
Eyelid-pigmentation1 (1.2)0
Eye irritation1 (1.2)0
Eye pain1 (1.2)0
Eyelids pruritus1 (1.2)0
Immune system disorders, n (%)1 (1.2)ā€‰
Hypersensitivity1 (1.2)0

A subject with more than one event in a specific category was only counted once. MedDRA coding; due to splitting of terms, number of MedDRA terms can be different from number of reported events. MedDRA version 18.0.
MedDRA, Medical Dictionary for Regulatory Activities; TEAEs, treatment-emergent adverse events; TTFC, travoprost 0.004%/timolol 0.5% fixed-dose combination.