| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05234554 | The INVIGORATE 2 Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis | PHASE3 | COMPLETED | 131 | — | — | Jan 21, 2022 | Apr 22, 2023 | May 14, 2026 | 1 | Canada |
| NCT04207736 | The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis. | PHASE3 | COMPLETED | 95 | — | — | Dec 5, 2019 | Feb 16, 2021 | Nov 20, 2024 | 1 | Canada |
| NCT03494504 | ALLEVIATE Trial - A Phase 3 Trial in Subjects With Allergic Conjunctivitis | PHASE3 | COMPLETED | 318 | — | — | Mar 30, 2018 | Nov 5, 2018 | Feb 11, 2025 | 7 | United States |
| NCT03660878 | A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis | PHASE1 | COMPLETED | 52 | — | — | Sep 8, 2018 | Nov 19, 2019 | Apr 8, 2025 | 1 | United States |
The method of assessment was a 9-point ocular itch scale measured in half-unit increments (0 none - 4 severe) with a higher score representing worse symptomology. Subjects were dosed once just prior to allergen chamber entry and again halfway through the chamber. The allergen chamber was 210 ten minutes in duration with the itching assessment being collected every 10 minutes from 110 to 210 minutes. The timepoints were assessed using mixed model repeated measures.
Change from baseline comparison of reproxalap to vehicle for ocular itching on a 0 to 4 scale ( 0 = none, 4 = severe). The treatment comparison was performed using a mixed model repeated measures approach for a crossover trial with two treatment periods. The model included time point, treatment, treatment period, treatment sequence, and interaction between time point and treatment as fixed effects, and subject nested within treatment sequence as a repeated measure.
Subject-reported ocular itching score area under the curve from 10 to 60 minutes post allergen challenge using a 0 to 4 scale (0 = none, 4 = severe) was assessed. The least squares mean was derived from analysis of covariance of area under the curve with baseline as a covariate and treatment as a fixed effect The possible range for area under the curve least squares mean is 0 to 100, where a lower score is better.
Mean change from baseline in ocular itching score using a 0 to 4 scale (0 = least, 4 = most) was assessed on days when peak pollen counts meet or exceed the American Academy of Allergy Asthma \& Immunology weed pollen scale 95th percentile (325 grains per cubic meter). The least squares mean (standard error) was derived from analysis of covariance with baseline, treatment, and day as factors.
| Arm | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | EXPERIMENTAL | - |
| Vehicle Ophthalmic Solution | PLACEBO_COMPARATOR | - |
| Reproxalap Ophthalmic Solution (0.5%) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Reproxalap Ophthalmic Solution (0.25%) | DRUG | Reproxalap Ophthalmic Solution (0.25%) dosed twice. |
| Vehicle Ophthalmic Solution | DRUG | Vehicle Ophthalmic Solution dosed twice. |
| Reproxalap Ophthalmic Solution (0.5%) | DRUG | Reproxalap Ophthalmic Solution (0.5%) administered once. |
Inclusion Criteria: * Be at least 18 years of age at the time of screening of either sex or any race; * Provide written informed consent; * Be willing and able to follow instructions, and can attend all required clinical trial visits. * Have at least a two-year history of moderate-to-severe ragweed...