An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Mean Itching Score by Visit
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts 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 exclusion criteria may apply.
Arms & Interventions
AL-4943A
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks
Intervention: Olopatadine Hydrochloride Ophthalmic Solution, 0.2% (Drug)
Outcomes
Primary Outcomes
Mean Itching Score by Visit
Time Frame: 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
Time Frame: 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 Outcomes
- Mean Subjective Symptoms by Visit(Up to Week 10)