Safety and Comfort of AL-4943A Ophthalmic Solution
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: Olopatadine hydrochloride ophthalmic solution, 0.7% (Drug); Olopatadine hydrochloride ophthalmic solution vehicle (Drug); Ketotifen fumarate ophthalmic solution, 0.025% (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Alcon Research Official(s) and/or principal investigator(s): Abhijit Narvekar, MS, MBBS, Study Director, Affiliation: Alcon Research
Summary
The purpose of this study is to assess the ocular comfort and safety of olopatadine
hydrochloride opthalmic solution. 0. 7%.
Clinical Details
Official title: A Randomized, Double-Masked, Crossover Study to Evaluate the Safety and Comfort of AL-4943A Ophthalmic Solution, 0.7%
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Peak discomfort score over a 3-minute period after drop instillation
Secondary outcome: Ocular SymptomsProduct Acceptability
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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 exclusion criteria may apply.
Locations and Contacts
Additional Information
Starting date: April 2011
Last updated: February 27, 2015
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