Allergic Conjunctivitis
Conditions
Keywords
Ocular discomfort, AL-4943A Ophthalmic Solution
Brief summary
The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.
Detailed description
In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.
Interventions
DRUGOlopatadine hydrochloride ophthalmic solution, 0.7%
Treatment A
Treatment B, inactive ingredients used as placebo
DRUGKetotifen fumarate ophthalmic solution, 0.025%
Treatment C
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits. * Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease. * History of any clinically significant external ocular disease within 30 days of the start of the study. * Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak discomfort score over a 3-minute period after drop instillation | Up to Day 3 | Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Symptoms | Up to Day 3 | Ocular symptoms (burning, stinging, tearing, blurring, and stickiness) assessed by the subject after instillation of drop as a single score where 0=none to 9=severe. |
| Product Acceptability | Up to Day 3 | Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable. |
Outcome results
None listed