Reproxalap Improves Signs and Symptoms of Allergic Conjunctivitis in an Allergen Chamber: A Real-World Model of Allergen Exposure

Figures & data

Table 1 Baseline Demographic Characteristics

Parameter	Category	ITT/Safety/Randomized Population N = 70 n (%)	Per Protocol Population N = 66 n (%)
Sex	Male	28 (40.0)	27 (40.9)
	Female	42 (60.0)	39 (59.1)
Age, years	N	70	66
	Mean ± SD	46.9 ± 10.07	46.9 ± 9.55
	Median	47.5	47.5
	Range	27–68	27–68
Racial designation	White	45 (64.3)	42 (63.6)
	American Indian or Alaska Native	0	0
	Black or African American	14 (20.0)	13 (19.7)
	Native Hawaiian/other Pacific Islander	0	0
	Asian	9 (12.9)	9 (13.6)
	Other	2 (2.9)	2 (3.0)
Ethnicity	Hispanic or Latino	9 (12.9)	9 (13.6)
	Not Hispanic or Latino	61 (87.1)	57 (86.4)
	Not reported	0	0
	Unknown	0	0

Note: Age derived using the following formula: (date of informed consent signed – date of birth)/365.25.

Abbreviations: ITT, intent-to-treat; N, number of randomized patients in the population; n, number of patients with data; SD, standard deviation.

Figure 1 Patient disposition. Sequence A = 0.25% reproxalap, 0.5% reproxalap, and vehicle; sequence B = 0.5% reproxalap, vehicle, and 0.25% reproxalap; sequence C = vehicle, 0.25% reproxalap, and 0.5% reproxalap.

Figure 2 Patient-reported ocular itching score. P values derived from mixed effect models for repeated measures analysis of change from baseline (just prior to chamber entry) over all time points in aggregate.

Figure 3 Patient-reported ocular tearing score. P values derived from mixed effect models for repeated measures analysis of change from baseline (just prior to chamber entry) over all time points in aggregate.

Figure 4 Investigator-assessed conjunctival redness score. P values derived from mixed effect models for repeated measures analysis of change from baseline (just prior to chamber entry) over all time points in aggregate.

Figure 5 Time to patient-reported ocular itching score of ≥2 for 0.25% reproxalap versus vehicle. P value derived from log-rank analysis.

Figure 6 Time to investigator-assessed conjunctival redness score of ≥2 for 0.25% reproxalap versus vehicle. P value derived from log-rank analysis.