Pooled analysis of two studies evaluating efficacy and safety of olopatadine hydrochloride 0.77% in patients with allergic conjunctivitis

Figures & data

Figure 1 Patient disposition.

Notes: ^aDue to adverse events not related to the drug, n (%): olopatadine HCl 0.77%, 4 (2.4); vehicle, 1 (0.9).

Table 1 Demographic and baseline characteristics (ITT population)

Parameters	Olopatadine HCl 0.77% (n=164)	Olopatadine 0.2% (n=167)	Vehicle (n=117)
Age (years)
Mean (±SD)	39.7 (12.9)	41.3 (13.9)	41.7 (12.8)
18–64, n (%)	161 (98.2)	159 (95.2)	114 (97.4)
≥65, n (%)	3 (1.8)	8 (4.8)	3 (2.6)
Gender, n (%)
Male	60 (36.6)	70 (41.9)	46 (39.3)
Female	104 (63.4)	97 (58.1)	71 (60.7)
Ethnicity, n (%)
Hispanic or Latino	26 (15.9)	20 (12.0)	12 (10.3)
Not Hispanic or Latino	137 (83.5)	147 (88.0)	105 (89.7)
Race, n (%)
Caucasian	131 (79.9)	124 (74.3)	92 (78.6)
African American	27 (16.5)	37 (22.2)	17 (14.5)
Asian	2 (1.2)	2 (1.2)	3 (2.6)
American Indian or Alaska Native	2 (1.2)	1 (0.6)	3 (2.6)
Multiracial	1 (0.6)	0 (0.0)	0 (0.0)
Other	1 (0.6)	3 (1.8)	2 (1.7)
Allergen, n (%)
Cat dander	17 (10.4)	11 (6.6)	13 (11.1)
Grass	66 (40.2)	74 (44.3)	45 (38.5)
Ragweed	32 (19.5)	16 (9.6)	27 (23.1)
Trees	21 (12.8)	24 (14.4)	10 (8.5)
Dust mites	24 (14.6)	36 (21.6)	19 (16.2)
Cockroach	2 (1.2)	2 (1.2)	2 (1.7)
Dog dander	2 (1.2)	4 (2.4)	1 (0.9)

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

Abbreviations: ITT, intent-to-treat; SD, standard deviation.

Figure 2 Ocular itching: treatment differences in least squares means at onset and 24 hours post-CAC.

Notes: *P<0.0001 overall and at all time points versus vehicle; **P<0.05 versus olopatadine 0.2%. The differences in least squares means for ocular itching between olopatadine 0.77% and vehicle were significant (P<0.0001) at all three post-CAC time points at onset and 24 hours. The differences in least squares means for ocular itching between olopatadine 0.77% and olopatadine 0.2% were significant (P<0.05) at all three post-CAC time points at 24 hours.
Abbreviation: CAC, conjunctival allergen challenge.

Figure 3 Conjunctival redness: treatment differences in least squares means at onset and 24 hours post-CAC.

Notes: *P<0.0001 overall and at all other time points versus vehicle; **P<0.05 overall and at all time points versus olopatadine 0.2%. The differences in least squares means for conjunctival redness between olopatadine 0.77% and both vehicle and olopatadine 0.2% were significant (P<0.05) at all three post-CAC time points at 7, 15, and 20 minutes.
Abbreviation: CAC, conjunctival allergen challenge.

Figure 4 Total redness: treatment differences in least squares means at onset and 24 hours post-CAC.

Notes: *P<0.0001 overall and at all other time points versus vehicle; **P<0.05 overall and at all time points versus olopatadine 0.2%. The differences in least squares means for total redness between olopatadine 0.77% and both vehicle and olopatadine 0.2% were significant (P<0.05) at all three post-CAC time points at 7, 15, and 20 minutes.
Abbreviation: CAC, conjunctival allergen challenge.

Figure 5 Itching responders: treatment differences in proportion of responders at 24 hour duration of action CAC or CAC 24 hours post treatment.

Notes: *P<0.0001 overall and at all other time points versus vehicle; **P=0.4142 at onset of action; ***P=0.0012 at 24 hours of CAC versus olopatadine 0.2%. The differences in least squares means for proportion of ocular itching responders between olopatadine 0.77% and vehicle at onset and 24 hours (P<0.0001) and between olopatadine 0.77% and olopatadine 0.2% at 24 hours (P=0.0012) were significant. A responder was defined as a patient with zero itch (a score of 0 on ocular itching for both the eyes) or with at least a 2-unit reduction in ocular itching relative to a baseline score. Two subjects (one in olopatadine 0.77% group, one in vehicle group) had missing data and were considered as nonresponders in this analysis. Ocular itching score was averaged across both the eyes and over the three post-CAC assessments (3, 5, and 7 minutes) for the calculation of unit reduction.
Abbreviation: CAC, conjunctival allergen challenge.

Table 2 Ocular signs and symptoms: treatment difference in means at onset and 24 hours post-CAC

Secondary endpoints	Difference in means between olopatadine HCl 0.77% versus vehicle and olopatadine 0.2% at onset of action			Difference in means between olopatadine HCl 0.77% versus vehicle and olopatadine 0.2% at 24-hour duration of action
	7 minutes	15 minutes	20 minutes	7 minutes	15 minutes	20 minutes
Ciliary rednessa
Vehicle	−1.01*	−0.91*	−0.87*	−0.51*	−0.41*	−0.30**
Olopatadine 0.2%	−0.36*	−0.50*	−0.49*	−0.24**	−0.28**	−0.21**
Episcleral rednessa
Vehicle	−0.94*	−0.78*	−0.75*	−0.39*	−0.35**	−0.27**
Olopatadine 0.2%	−0.38*	−0.46*	−0.47*	−0.26**	−0.25**	−0.20**
Chemosisb
Vehicle	−0.42*	−0.49*	−0.49*	−0.36*	−0.44*	−0.45*
Olopatadine 0.2%	−0.06	−0.18**	−0.18**	−0.07	−0.14	−0.12
Eyelid swellingc
Vehicle	−0.50*	−0.40*	−0.30*	−0.50*	−0.40**	−0.30**
Olopatadine 0.2%	−0.10	−0.10	−0.10	−0.20**	−0.10	−0.10
Tearingd
Vehicle	−0.50*	−0.40*	−0.30^†	−0.50*	−0.30**	−0.20
Olopatadine 0.2%	0	−0.10	−0.10	−0.10	−0.10	−0.10

Notes:

a Ciliary and episcleral redness each were assessed on a 0–4 scale by 0.5-unit increments: 0= none and 4= extremely severe;

b chemosis was assessed on a 0–4 scale by 0.5-unit increments: 0= none and 4= severe;

c eyelid swelling was assessed on a 0–3 scale with 1-unit increments: 0= none and 3= severe; and

d tearing was assessed on a 0–4 scale by 1-unit increments: 0= none and 4= very severe.

* P<0.0001 overall and at all other time points versus vehicle;

** P<0.05 overall and at all time points versus olopatadine 0.2%.

Abbreviation: CAC, conjunctival allergen challenge.

Table 3 AEs (≥1% in any treatment group; safety set)

AE category (MedDRA PT presented by SOC), n (%)	Olopatadine HCl 0.77% (n=164)	Olopatadine 0.2% (n=167)	Vehicle (n=117)
Eye disorders
Eye irritation	2 (1.2)	0	1 (0.9)
Vision blurred	0	1 (0.6)	2 (1.7)
VA reduced	2 (1.2)	1 (0.6)	0
Infections and infestations
Gastroenteritis viral	3 (1.8)	0	0
Nervous system disorders
Dysgeusia	2 (1.2)	0	0
Respiratory, thoracic, and mediastinal disorders
Cough	0	0	2 (1.7)

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

Abbreviations: AEs, adverse events; MedDRA, Medical Dictionary for Regulatory Activities; PT, preferred term; SOC, system organ class; VA, visual acuity.