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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


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 Symptoms

Product 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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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