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Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis

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: AL-4943A ophthalmic solution (Drug); Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug); Olopatadine hydrochloride ophthalmic solution, 0.1% (Drug); AL-4943A ophthalmic solution vehicle (Drug)

Phase: Phase 3

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 evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

Clinical Details

Official title: Phase 3, Efficacy and Safety Study of AL-4943A Ophthalmic Solution, 0.77% in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Mean Ocular Itching at Onset of Action

Mean Ocular Itching at 24 Hours Duration of Action

Secondary outcome:

Mean Conjunctival Redness at Onset of Action

Mean Conjunctival Redness at 24 Hours Duration of Action

Mean Total Redness at Onset of Action

Mean Total Redness at 24 Hours Duration of Action

Proportion of Ocular Itching Responders at Onset of Action

Proportion of Itch Responders at 24 Hours Duration of Action

Detailed description: Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurred. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.


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


Inclusion Criteria:

- Able to be dosed in both eyes, able and willing to make the required study visits and

to follow instructions.

- Negative urine pregnancy test if female of childbearing potential and use adequate

birth control throughout the study period.

- Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses,

ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.

- History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to

Visit 1.

- Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS

(letters read method).

- Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.

- Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and

throughout the study.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Known history or presence of persistent dry eye syndrome, or currently requires

frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.

- Presence of an ocular condition that may affect the study outcomes.

- History or evidence of ocular surgery (including refractive procedures such as LASIK,

PRK and RK) within 6 months of Visit 1.

- Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits

1, 2, 3A, or 4.

- History of anaphylactic reaction to any allergens used in this study.

- Current evidence or recent (within 6 months) history of severe, unstable, or

uncontrolled medical conditions and/or other relevant systemic diseases.

- Use of any disallowed medication without protocol-specified washout period prior to

Visit 1, or during the study.

- Other protocol-defined exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: January 2013
Last updated: July 18, 2014

Page last updated: August 23, 2015

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