Allergic Conjunctivitis
Conditions
Brief summary
The objective of this study is to assess safety and efficacy of long-term use of AL-4943A (Olopatadine Hydrochloride Ophthalmic Solution, 0.2%) in patients with allergic conjunctivitis.
Interventions
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must provide written consent. * Subjects must have a diagnosis of allergic conjunctivitis. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Itching and/or hyperemia associated with diseases other than allergic conjunctivitis. * Retinal detachment, diabetic retinopathy, or any progressive disease in posterior segment of the eye. * Known history of ocular infection. * Contact lens wear during study. * Pregnant, nursing. * Participation in another clinical study within 30 days of Informed Consent. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Itching Score by Visit | Up to Week 10 | Ocular itching will be assessed by the subject and graded on a 6-point scale, where 0=did not occur and 5=virtually all the time over the past 3 days. |
| Mean Total Hyperemia Score by Visit | Up to Week 10 | Ocular hyperemia (redness) will be assessed by the investigator. Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctival scores. |
Secondary
| Measure | Time frame |
|---|---|
| Mean Subjective Symptoms by Visit | Up to Week 10 |
Countries
Japan
Outcome results
None listed