A Methodology Development Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber

• Reproxalap Ophthalmic Solution (0.25%) (Drug): Reproxalap Ophthalmic Solution (0.25%) dosed twice.
• Reproxalap Ophthalmic Solution (0.5%) (Drug): Reproxalap Ophthalmic Solution (0.5%) dosed twice.
• Vehicle Ophthalmic Solution (Drug): Vehicle Ophthalmic Solution dosed twice.

Primary outcomes

• Subject-Reported Ocular Itching Score [Efficacy was assessed from 0 to 212 minutes in the allergen chamber.]: Change from baseline comparison of reproxalap to vehicle for subject-reported ocular itching score from 0 to 212 minutes in the allergen chamber using a 0 -100 millimeter visual analogue scale (0 = none, 100 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.

Secondary outcomes

• Subject-Reported Ocular Tearing Score [Efficacy was assessed from 0 to 212 minutes in the allergen chamber.]: Change from baseline comparison of reproxalap to vehicle for subject-reported ocular tearing score from 0 to 212 minutes in the allergen chamber using a 4-point scale (0 = none, 3 = severe) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.
• Investigator-Assessed Conjunctival Redness Score [Efficacy was assessed from 0 to 210 minutes in the allergen chamber.]: Change from baseline comparison of reproxalap to vehicle for investigator-assessed conjunctival redness from 0 to 210 minutes in the allergen chamber using a 9-point scale with half unit increments (0 = normal, 4 = prominent) was assessed. The least squares mean (standard error) was derived from mixed model repeated measures for change from baseline included itching score as a dependent variable, treatment, period, and interaction of treatment and period as fixed effects.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* be at least 18 years of age of either gender and any race
* have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
* have a positive skin prick test to ragweed pollen within the past year of screening

Exclusion Criteria:

* known contraindication or hypersensitivities to any components of the investigational product medication or components
* history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
* presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
* presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
* presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial
* diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
* woman of childbearing potential who is pregnant or nursing

Participant flow

Outcome results

• Subject-Reported Ocular Itching Score (Primary), Least squares mean, units on a scale: Reproxalap (0.25%) 16.410 +/- 1.6195; Reproxalap (0.5%) 16.964 +/- 1.6150; Vehicle 22.310 +/- 1.6188
• Subject-Reported Ocular Tearing Score (Secondary), Least squares mean, units on a scale: Reproxalap (0.25%) 0.8777 +/- 0.0615; Reproxalap (0.5%) 0.8915 +/- 0.0613; Vehicle 1.0507 +/- 0.0614
• Investigator-Assessed Conjunctival Redness Score (Secondary), Least squares mean, units on a scale: Reproxalap (0.25%) 0.5004 +/- 0.0458; Reproxalap Ophthalmic Solution (0.5%) 0.5462 +/- 0.0457; Vehicle 0.6497 +/- 0.0458

Adverse events

Time frame: The period of time over which adverse events were collected for each subject in the clinical trial was approximately fourteen weeks.

Other adverse events by term

• Study Protocol (PDF, 2018-11-22)
• Statistical Analysis Plan (PDF, 2019-03-03)