Efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis using a conjunctival allergen-challenge model

Figures & data

Figure 1 Study flow diagram.

Note: Olopatadine 0.77% refers to olopatadine HCl 0.77% (equivalent to olopatadine 0.7% free base)-treatment group.
Abbreviation: CAC, conjunctival allergen-challenge.

Table 1 Demographic and baseline characteristics (intent-to-treat population)a

Characteristics	Olopatadine 0.77% (n=66)	Olopatadine 0.2% (n=66)	Vehicle (n=68)
Age, years
Mean (SD)	40.9 (13.1)	40.7 (14.2)	41.8 (13.3)
Range	18–68	18–73	19–77
18–64, n (%)	64 (97.0)	64 (97.0)	66 (97.1)
≥65, n (%)	2 (3.0)	2 (3.0)	2 (2.9)
Sex, n (%)
Male	23 (34.8)	24 (36.4)	29 (42.6)
Female	43 (65.2)	42 (63.6)	39 (57.4)
Eethnicity, n (%)
White	50 (75.8)	52 (78.8)	57 (83.8)
Black or African-American	14 (21.2)	11 (16.7)	8 (11.8)
Asian	1 (1.5)	1 (1.5)	1 (1.5)
American Indian or Alaska Native	1 (1.5)	1 (1.5)	1 (1.5)
Other	0	1 (1.5)	1 (1.5)
Allergen type, n (%)
Ragweed	23 (34.8)	9 (13.6)	18 (26.5)
Grass	17 (25.8)	22 (33.3)	23 (33.8)
Trees	7 (10.6)	8 (12.1)	5 (7.4)
Dust mites	11 (16.7)	20 (30.3)	11 (16.2)
Cat dander	7 (10.6)	6 (9.1)	10 (14.7)
Dog dander	1 (1.5)	1 (1.5)	1 (1.5)

Notes:

a The intent-to-treat population included all randomized patients who received treatment and had post-conjunctival allergen-challenge data. Olopatadine 0.77% refers to olopatadine HCl 0.77% (equivalent to olopatadine 0.7% free base)-treatment group.

Abbreviation: SD, standard deviation.

Figure 2 Treatment differences in means after conjunctival allergen-challenge (CAC): primary end points (intent-to-treat population).

Notes: *P<0.001; **P<0.01; ***P<0.05. Ocular itching (A) examined at 3, 5, and 7 minutes, and conjunctival redness (B) examined at 7, 15, and 20 minutes after CAC. Olopatadine 0.77% refers to olopatadine HCl 0.77% (equivalent to olopatadine 0.7% free base)-treatment group.

Figure 3 Treatment differences in means after conjunctival allergen-challenge (CAC): supportive end points (intent-to-treat population).

Notes: *P<0.001; **P<0.01; ***P<0.05. Chemosis (A) and tearing (B) at 7, 15, and 20 minutes after CAC. Olopatadine 0.77% refers to olopatadine HCl 0.77% (equivalent to olopatadine 0.7% free base)-treatment group.

Table 2 Summary of treatment-emergent AEs (safety population)

AE category, n (%)	Olopatadine 0.77% (n=66)	Olopatadine 0.2% (n=68)	Vehicle (n=68)
Discontinued because of AE	2 (3.0)	0	1 (1.5)
Treatment-related	0	0	0
Not treatment-related	2 (3.0)	0	1 (1.5)
Patients with one or more treatment-emergent	6 (9.1)	5 (7.4)	5 (7.4)
AE
Patients with one or more treatment-emergent	1 (1.5)	0	1 (1.5)
AE related to treatment
Treatment-related AEs
Vision blurred	0	0	1 (1.5)
Headache	1 (1.5)	0	0

Note: Olopatadine 0.77% refers to olopatadine HCl 0.77% (equivalent to olopatadine 0.7% free base)-treatment group.

Abbreviation: AE, adverse event.