An Open-label, Long-term Study, With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis
This study has been completed.
Information provided by (Responsible Party):
First received: December 18, 2009
Last updated: January 11, 2012
Last verified: January 2012
The objective of this study is to assess safety and efficacy of long-term use of AL-4943A Ophthalmic Solution, 0.2% in patients with allergic conjunctivitis.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Long-term Study, With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Itching [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Ocular itching, as assessed by the subject, was graded on a 6-point scale: 0=did not occur; 1=once; 2=at least once on two days; 3=at least once every day; 4=two or more time every day; 5=virtually all the time over the past three days.
- Hyperemia [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]Ocular hyperemia (redness) was assessed by the investigator for the palpebral conjunctiva and the bulbar conjunctiva. Hyperemia was assessed using a 6-point pictorial scale ranging from 0 (representing no hyperemia) to 5. The palpebral and bulbar conjunctival scores were summed together for a total hyperemia score.
|Study Start Date:||February 2010|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Olopatadine 0.2%
Two drops instilled into both eyes, twice daily, for 10 weeks
Drug: AL-4943A (olopatidine 0.2%)
Ophthalmic solution containing olopatidine 2.22 mg 0.2%) in 1 mL.
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