Allergic Conjunctivitis
Conditions
Brief summary
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.
Interventions
DRUGKetoNaph
Ophthalmic Solution administered BID for 6 weeks
DRUGVehicle
Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects less than 18 years of age, have either a history or family history of ocular allergy. * ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.
Exclusion criteria
* Contraindications or sensitivities to the use of any of the investigational product(s) or their components. * Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1. * Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months. * A known history of retinal detachment, diabetic retinopathy, or active retinal disease; * An active ocular infection (bacterial, viral or fungal * Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment. * Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment. * Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications. * Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Adverse Event. | 42 days | An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| KetoNaph KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05%
KetoNaph: Ophthalmic Solution administered BID for 6 weeks | 357 |
| Vehicle Vehicle of KetoNaph Ophthalmic Solution
Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks | 177 |
| Total | 534 |
Baseline characteristics
| Characteristic | KetoNaph | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 31.8 years STANDARD_DEVIATION 17.2 | 31.0 years STANDARD_DEVIATION 16.6 | 31.5 years STANDARD_DEVIATION 17 |
| Sex: Female, Male Female | 207 Participants | 97 Participants | 304 Participants |
| Sex: Female, Male Male | 150 Participants | 80 Participants | 230 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 20 / 357 | 1 / 177 |
| serious Total, serious adverse events | 3 / 357 | 1 / 177 |
Outcome results
Primary
Percentage of Participants With at Least One Adverse Event.
An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.
Time frame: 42 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| KetoNaph | Percentage of Participants With at Least One Adverse Event. | 113 Participants |
| Vehicle | Percentage of Participants With at Least One Adverse Event. | 34 Participants |