Allergic Conjunctivitis
Conditions
Brief summary
The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (EEC).
Interventions
Reproxalap Ophthalmic Solution (0.25%) dosed twice.
DRUGVehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed twice.
Sponsors
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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-induced allergic conjunctivitis based on investigator's judgement; * Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).
Exclusion criteria
* Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis; * Have systemic signs of infection (e.g., fever, current treatment with antibiotics). * Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease; * Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception; * Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-Reported Ocular Itching Score Assessed in the Allergy Chamber | 110 to 210 minutes during allergen chamber exposure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness Evaluated by the Investigator | 12 to 212 minutes during allergen chamber exposure | The method of assessment was a 9-point ocular redness scale measured in half-unit increments (0 none - 4 extremely 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 212 minutes in duration with the redness assessment being collected every 10 minutes from 12 to 212 minutes. The timepoints were assessed using mixed model repeated measures. |
Countries
Canada
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 10 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Region of Enrollment Canada | 131 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 131 |
| other Total, other adverse events | 93 / 130 | 5 / 131 |
| serious Total, serious adverse events | 0 / 130 | 0 / 131 |
Outcome results
None listed