Allergic Conjunctivitis
Conditions
Keywords
reproxalap, INVIGORATE, ADX-102
Brief 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.
Detailed description
The INVIGORATE Trial: A 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 in the Environmental Exposure Chamber.
DRUGVehicle Ophthalmic Solution
Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber | The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber | The efficacy assessment period was 12 to 212 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period. | Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = none, 4 = extremely 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. |
Countries
Canada
Participant flow
Pre-assignment details
Ninety-five subjects were randomized in a crossover design trial; efficacy was assessed in an allergy chamber.
Participants by arm
| Arm | Count |
|---|---|
| Reproxalap (0.25%), Then Vehicle Subjects first received reproxalap ophthalmic solution twice in a single day. After a washout period of approximately two weeks, subjects then received vehicle ophthalmic solution twice in a single day. | 48 |
| Vehicle, Then Reproxalap (0.25%) Subjects first received vehicle ophthalmic solution twice in a single day. After a washout period of approximately two weeks, subjects then received reproxalap ophthalmic solution twice in a single day. | 47 |
| Total | 95 |
Baseline characteristics
| Characteristic | Vehicle, Then Reproxalap (0.25%) | Total | Reproxalap (0.25%), Then Vehicle |
|---|---|---|---|
| Age, Continuous | 41.9 years STANDARD_DEVIATION 11.13 | 41.1 years STANDARD_DEVIATION 12.29 | 40.3 years STANDARD_DEVIATION 13.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 89 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 19 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 55 Participants | 25 Participants |
| Sex: Female, Male Female | 27 Participants | 53 Participants | 26 Participants |
| Sex: Female, Male Male | 20 Participants | 42 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 93 |
| other Total, other adverse events | 69 / 91 | 6 / 93 |
| serious Total, serious adverse events | 0 / 91 | 0 / 93 |
Outcome results
Primary
Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber
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.
Time frame: The efficacy assessment period was 110 to 210 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reproxalap (0.25%) | Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber | 0.94 score on a scale | Standard Error 0.08 |
| Vehicle | Subject-Reported Ocular Itching Score Assessed Over 110 to 210 Minutes in the Allergy Chamber | 1.38 score on a scale | Standard Error 0.08 |
Secondary
Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber
Change from baseline comparison of reproxalap to vehicle for conjunctival redness on a 0 to 4 scale ( 0 = none, 4 = extremely 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.
Time frame: The efficacy assessment period was 12 to 212 minutes in the allergy chamber; baseline was pre-Dose #1 for each treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Reproxalap (0.25%) | Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber | 0.51 score on a scale | Standard Error 0.03 |
| Vehicle | Conjunctival Redness Score Assessed Over 12 to 212 Minutes in the Allergy Chamber | 0.65 score on a scale | Standard Error 0.03 |