Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.
Interventions
DRUGalcaftadine
0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
DRUGPlacebo
Vehicle without active, one drop in each eye at each of two visits.
Sponsors
Vistakon Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 10 years of age * positive history of ocular allergies * positive skin test reaction to allergens.
Exclusion criteria
* known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components * ocular surgical intervention within three (3) months prior to visit 1 or during the study * known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma * any other significant illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation | Visit 4 (Day 14) At 20 minutes following Allergen Challenge | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. |
| Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. | Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge | A 0 to 4 scale used, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation. |
| Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation | Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment | A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation. |
| Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation | Visit 4 (Day 14) up to 7 minutes following Allergen Challenge | 0 to 4 scale, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | Visit 2 (Day -14) pre-allergen challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | Visit 3 (Day 0) pre-dose, pre-allergen challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus |
| Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14 | Visit 2 (Day -14) pre-allergen challenge | The number of eyes with any change in visual acuity measurements compared to Day -21. |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | Visit 4 (Day 14) pre-dose, pre-allergen challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | Visit 4 (Day 14) post-dose, pre-allergen challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus |
| Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | Visit 3 (Day 0) post-dose, pre-allergen challenge | The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus |
| Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | Visit 3 (Day 0) pre-dose, pre-allergen challenge | The number of eyes with any change in visual acuity measurements compared to Day -21 |
| Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | Visit 4 (Day 14) pre-dose, pre-allergen challenge | The number of eyes with any change in visual acuity measurements compared to Day -21 |
| Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Visit 4 (Day 14) pre-dose, pre-allergen challenge | The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alcaftadine Ophthalmic Solution active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14. | 30 |
| Inactive Vehicle Ophthalmic Solution inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Alcaftadine Ophthalmic Solution | Inactive Vehicle Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Continuous | 37.8 years STANDARD_DEVIATION 13.52 | 34.3 years STANDARD_DEVIATION 15.64 | 36.1 years STANDARD_DEVIATION 40 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 21 Participants | 15 Participants | 36 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Time frame: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation | 1.96 units on a scale | Standard Deviation 0.846 |
| Inactive Vehicle Ophthalmic Solution | Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation | 2.50 units on a scale | Standard Deviation 0.579 |
Primary
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates none and 4 indicates extremely red; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Time frame: Visit 4 (Day 14) At 20 minutes following Allergen Challenge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation | 1.57 units on a scale | Standard Deviation 0.863 |
| Inactive Vehicle Ophthalmic Solution | Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation | 2.15 units on a scale | Standard Deviation 0.822 |
Primary
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
A 0 to 4 scale used, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.
Time frame: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. | 0.69 units on a scale | Standard Deviation 0.691 |
| Inactive Vehicle Ophthalmic Solution | Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. | 2.27 units on a scale | Standard Deviation 0.97 |
Primary
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
0 to 4 scale, allowing for half increment scores, where 0 indicates none and 4 indicates incapacitating itch with an irresistible urge to rub
Time frame: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation | 0.42 units on a scale | Standard Deviation 0.509 |
| Inactive Vehicle Ophthalmic Solution | Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation | 1.90 units on a scale | Standard Deviation 1.058 |
Other Pre-specified
Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14
The number of eyes with any change to the following: Vitreous, Retina, Macula, Choroid, Optic Nerve
Time frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Retina | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Choroid | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Macula | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Optic Nerve | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Vitreous | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Optic Nerve | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Vitreous | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Retina | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Macula | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Undilated Fundoscopy Changes From Visit 1 (Day -21) at Day 14 | Choroid | 0 eyes |
Other Pre-specified
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
The number of eyes with any change in visual acuity measurements compared to Day -21
Time frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | 1 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | 0 eyes |
Other Pre-specified
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14
The number of eyes with any change in visual acuity measurements compared to Day -21.
Time frame: Visit 2 (Day -14) pre-allergen challenge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14 | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14 | 1 eyes |
Other Pre-specified
Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
The number of eyes with any change in visual acuity measurements compared to Day -21
Time frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | 1 eyes |
Other Pre-specified
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time frame: Visit 3 (Day 0) post-dose, pre-allergen challenge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | lens | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | lids | 1 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | iris | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | iris | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | lens | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Post-dose, Pre-allergen Challenge | lids | 0 eyes |
Other Pre-specified
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time frame: Visit 3 (Day 0) pre-dose, pre-allergen challenge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | lens | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | lids | 1 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | iris | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | iris | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | lens | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge | lids | 0 eyes |
Other Pre-specified
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time frame: Visit 2 (Day -14) pre-allergen challenge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | cornea | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | lens | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | conjunctiva | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | lids | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | iris | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | tear meniscus | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | tear meniscus | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | conjunctiva | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | cornea | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | iris | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | lens | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day -14 | lids | 0 eyes |
Other Pre-specified
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time frame: Visit 4 (Day 14) post-dose, pre-allergen challenge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | lens | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | lids | 1 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | iris | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | iris | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | lens | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Post-dose, Pre-allergen Challenge | lids | 0 eyes |
Other Pre-specified
Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge
The number of eyes with any change in the following: anterior chamber, conjunctiva, cornea, iris, lens, lids, tear meniscus
Time frame: Visit 4 (Day 14) pre-dose, pre-allergen challenge
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | lens | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | lids | 1 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | iris | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Alcaftadine Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | tear meniscus | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | anterior chamber | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | conjunctiva | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | cornea | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | iris | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | lens | 0 eyes |
| Inactive Vehicle Ophthalmic Solution | Number of Eyes With Slit Lamp Biomicroscopy Changes From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge | lids | 0 eyes |