Table 3.

Treatment-emergent adverse events (TEAEs) and treatment-related ocular TEAEs.

	High-Dose Regimen, n (%) (n = 96)	Low-Dose Regimen, n (%) (n = 93)	Vehicle, n (%) (n = 98)
TEAEs*
All TEAEs	36 (37.5)	32 (34.4)	37 (37.8)
Drug-related TEAEs	21 (21.9)	16 (17.2)	17 (17.3)
Severity of TEAEs
Mild	16 (16.7)	24 (25.8)	13 (13.3)
Moderate	14 (14.6)	2 (2.2)	18 (18.4)
Severe	6 (6.3)	6 (6.5)	6 (6.1)
Severity of drug-related TEAEs
Mild	11 (11.5)	13 (14.0)	5 (5.1)
Moderate	8 (8.3)	1 (1.1)	9 (9.2)
Severe	2 (2.1)	2 (2.2)	3 (3.1)
Death	0	0	0
SAE	2 (2.1)	1 (1.1)	0
Drug-related SAE	0	0	0
Discontinuation due to TEAEs	5 (5.2)	0	10 (10.2)
Discontinuation due to drug-related TEAEs	3 (3.1)	0	5 (5.1)
Treatment-related ocular TEAEs (System Organ Class Preferred Term)**
General disorders & administration site conditions	13 (13.5)	16 (17.2)	6 (6.1)
Instillation site pain	9 (9.4)	7 (7.5)	4 (4.1)
Instillation site pruritus	5 (5.2)	7 (7.5)	3 (3.1)
Instillation site erythema	0	1 (1.1)	2 (2.0)
Drug intolerance	0	2 (2.2)	0
Application site discharge	0	0	1 (1.0)
Application site swelling	0	1 (1.1)	0
Eye disorders	10 (10.4)	2 (2.2)	9 (9.2)
Ocular hyperemia	3 (3.1)	2 (2.2)	1 (1.0)
Visual acuity reduced	3 (3.1)	0	2 (2.0)
Allergic keratitis	1 (1.0)	0	1 (1.0)
Ulcerative keratitis	0	0	2 (2.0)
Blepharospasm	1 (1.0)	0	0
Cataract subcapsular	0	0	1 (1.0)
Corneal leukoma	0	0	1 (1.0)
Eye irritation	1 (1.0)	0	0
Eye pain	1 (1.0)	0	0
Eyelid erosion	1 (1.0)	0	0
Eyelid oedema	0	0	1 (1.0)
Investigations	0	0	1 (1.0)
Increased IOP	0	0	1 (1.0)

AE adverse event, IOP intraocular pressure, Med DRA medical dictionary for regulatory activities, SAE serious adverse event, TEAE treatment-emergent adverse event.

*A patient was counted only once in his/her maximal severity.

**If a subject had more than one AE within the preferred term, he or she was counted only once; categories derived from Med DRA Version 19.0.