Allergic Conjunctivitis
Conditions
Keywords
Conjunctivitis, conjunctival inflammation, ocular allergies
Brief summary
The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.
Interventions
DRUGAL-38583 ophthalmic solution
DRUGAL-38583 ophthalmic solution vehicle
Inactive ingredients used as a placebo comparator
Sponsors
Ophthalmic Research Associates, Inc.
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of signs and symptoms of ocular inflammation in both eyes. * Have a positive CAC response at Visit 1. * Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Have known history or presence of persistent dry eye syndrome. * Presence of any ophthalmic abnormality that may affect the study outcomes. * Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores | Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Mean daily diary ocular redness scores | 2 week period between Day 0 and Day 14 |
Outcome results
None listed