Phase 3
Completed N=95
The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
Source: ClinicalTrials.gov NCT04207736 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber — 0.94; 1.38 score on a scale
◆ Published Evidence
Emerging
10citations · ~3 / year
The Phase 3 INVIGORATE Trial of Reproxalap in Patients with Seasonal Allergic Conjunctivitis.
Summary
The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.
Linked Publications
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The Phase 3 INVIGORATE Trial of Reproxalap in Patients with Seasonal Allergic Conjunctivitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber |
0.94; 1.38 | — |
| SECONDARY Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber |
0.51; 0.65 | — |
Eligibility Criteria
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;
- 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
Data sourced from ClinicalTrials.gov (NCT04207736) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.