Conjunctivitis, Allergic
Conditions
Keywords
ADX-102, Allergic Conjunctivitis
Brief summary
A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.
Interventions
DRUGVehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
DRUGADX-102 Ophthalmic Drops (0.5%)
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
DRUGADX-102 Ophthalmic Drops (0.1%)
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
Sponsors
ORA, Inc.
Aldeyra Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 a positive history of ocular allergies and a positive skin test reaction to a seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog dander, dust mites, cockroach) as confirmed by an allergic skin test within the past 24 months * have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart
Exclusion criteria
* have known contraindications or sensitivities to the use of the investigational product or any of its components * have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye) * have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (6) months * have a known history of retinal detachment, diabetic retinopathy, or active retinal disease * have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit * be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration and for 14 days prior to the installation of investigational product, or has a positive urine pregnancy test at Visit 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Efficacy assessment period (Day 1 through Day 15), Day 15 reported. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. |
| Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Efficacy assessment period (Day 1 through Day 15), Day 15 reported. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. |
| Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | Efficacy assessment period (Day 1 through Day 15), Day 15 reported. | Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ADX-102 Ophthalmic Drops (0.5%) ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.5%): ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks. | 53 |
| ADX-102 Ophthalmic Drops (0.1%) ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
ADX-102 Ophthalmic Drops (0.1%): ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks. | 51 |
| Vehicle of ADX-102 Ophthalmic Drops Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops: Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks. | 50 |
| Total | 154 |
Baseline characteristics
| Characteristic | ADX-102 Ophthalmic Drops (0.5%) | ADX-102 Ophthalmic Drops (0.1%) | Vehicle of ADX-102 Ophthalmic Drops | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 47 Participants | 48 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 5 Participants | 3 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 46 Participants | 46 Participants | 141 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Iris Color (Left Eye) Black | 0 participants | 0 participants | 1 participants | 1 participants |
| Iris Color (Left Eye) Blue | 8 participants | 11 participants | 10 participants | 29 participants |
| Iris Color (Left Eye) Brown | 31 participants | 29 participants | 26 participants | 86 participants |
| Iris Color (Left Eye) Gray | 0 participants | 1 participants | 0 participants | 1 participants |
| Iris Color (Left Eye) Green | 8 participants | 5 participants | 6 participants | 19 participants |
| Iris Color (Left Eye) Hazel | 6 participants | 5 participants | 7 participants | 18 participants |
| Iris Color (Left Eye) Other | 0 participants | 0 participants | 0 participants | 0 participants |
| Iris Color (Right Eye) Black | 0 participants | 0 participants | 1 participants | 1 participants |
| Iris Color (Right Eye) Blue | 8 participants | 11 participants | 10 participants | 29 participants |
| Iris Color (Right Eye) Brown | 31 participants | 29 participants | 26 participants | 86 participants |
| Iris Color (Right Eye) Gray | 0 participants | 1 participants | 0 participants | 1 participants |
| Iris Color (Right Eye) Green | 8 participants | 5 participants | 6 participants | 19 participants |
| Iris Color (Right Eye) Hazel | 6 participants | 5 participants | 7 participants | 18 participants |
| Iris Color (Right Eye) Other | 0 participants | 0 participants | 0 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 17 Participants | 13 Participants | 48 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 34 Participants | 34 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 35 Participants | 33 Participants | 0 Participants | 68 Participants |
| Sex: Female, Male Female | 40 Participants | 27 Participants | 30 Participants | 97 Participants |
| Sex: Female, Male Male | 13 Participants | 24 Participants | 20 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 51 | 0 / 49 |
| other Total, other adverse events | 0 / 53 | 0 / 51 | 0 / 49 |
| serious Total, serious adverse events | 0 / 53 | 0 / 51 | 0 / 49 |
Outcome results
Primary
Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Population: Intent to treat population with observed data only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADX-102 (0.5%) | Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 2.020 units on a scale | Standard Deviation 0.9821 |
| ADX-102 (0.1%) | Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 2.398 units on a scale | Standard Deviation 0.829 |
| Vehicle | Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 2.515 units on a scale | Standard Deviation 0.9661 |
Primary
Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Population: Intent to treat population with observed data only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADX-102 (0.5%) | Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 1.662 units on a scale | Standard Deviation 1.0085 |
| ADX-102 (0.1%) | Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 1.801 units on a scale | Standard Deviation 0.9601 |
| Vehicle | Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 1.985 units on a scale | Standard Deviation 0.9768 |
Primary
Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.
Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.
Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Population: Intent to treat with observed data only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ADX-102 (0.5%) | Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 1.152 units on a scale | Standard Deviation 0.9799 |
| ADX-102 (0.1%) | Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 1.434 units on a scale | Standard Deviation 0.9773 |
| Vehicle | Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15. | 1.551 units on a scale | Standard Deviation 1.0433 |