Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to evaluate the effectiveness and safety of Olopatadine Hydrochloride (HCl) ophthalmic solution 0.1% versus Epinastine HCl ophthalmic solution, 0.05% in a population of healthy, adult Japanese patients (20 years of age or older) with a history of allergic conjunctivitis to Japanese Cedar Pollen. Patients will be randomly assigned to receive Olopatadine HCl ophthalmic solution, 0.1% in one eye and Epinastine HCl ophthalmic solution, 0.05% in the fellow eye, after which a conjunctival allergy challenge (CAC) with Japanese cedar pollen will be performed.
Interventions
DRUGOlopatadine HCl ophthalmic solution, 0.1%
DRUGEpinastine HCl ophthalmic solution, 0.05%
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be Japanese and live in Japan; * History of allergic conjunctivitis; * Positive skin test reaction to Japanese cedar at Visit 1; * Positive bilateral CAC reaction to the allergen at Visit 1 and Visit 2; * Able and willing to avoid all disallowed medications during the specified period; * Able to discontinue wearing contact lenses during the specified period; * Sign Informed Consent; * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History of hypersensitivity to the study drug or compounds; * Any ocular condition that, in the opinion of the investigator, could affect the patient's safety; * Ocular surgical intervention within 3 months or refractive surgery within 6 months prior to the start of the study; * Presence of active ocular infection; * Use of disallowed medications as specified in the protocol; * Pregnant, nursing, or planning to become pregnant during the study; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 | Day 1, 7 minutes post-CAC | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 | Day 1, 20 minutes post-CAC | A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe). |
Participant flow
Recruitment details
Participants were recruited from 1 study site located in Japan.
Pre-assignment details
All subjects qualifying for treatment at Visit 3 were randomized. This reporting group includes all randomized participants (50).
Participants by arm
| Arm | Count |
|---|---|
| Overall Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Customized 20-29 years | 22 participants |
| Age, Customized 30-39 years | 13 participants |
| Age, Customized 40-49 years | 14 participants |
| Age, Customized ≥50 years | 1 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Mean Ocular Itching at 7 Minutes Post-CAC, Day 1
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Ocular itching was assessed by the patient for each eye at 7 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=incapacitating itch with irresistible urge to rub).
Time frame: Day 1, 7 minutes post-CAC
Population: This analysis population includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine 0.1% | Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 | 0.23 units on a scale | Standard Deviation 0.31 |
| Epinastine 0.05% | Mean Ocular Itching at 7 Minutes Post-CAC, Day 1 | 0.37 units on a scale | Standard Deviation 0.44 |
Secondary
Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1
A CAC (one drop of allergen solution to each eye) was performed 5 minutes after study medication instillation. Conjunctival hyperemia (redness) was evaluated by the investigator based on biomicroscopy for each eye at 20 (±1) minutes post-CAC and rated on a 0-4 scale (0=none, 4=extremely severe).
Time frame: Day 1, 20 minutes post-CAC
Population: This analysis population includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Olopatadine 0.1% | Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 | 0.89 units on a scale | Standard Deviation 0.88 |
| Epinastine 0.05% | Mean Conjunctival Hyperemia at 20 Minutes Post-CAC, Day 1 | 1.12 units on a scale | Standard Deviation 0.95 |