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

NCT ID: NCT01743027

Last Updated: 2014-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 902 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-07-31

Brief Summary

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.

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AL-4943A

AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

Group Type: EXPERIMENTAL

AL-4943A ophthalmic solution

Intervention Type: DRUG

PATADAY

Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

Group Type: ACTIVE_COMPARATOR

Olopatadine hydrochloride ophthalmic solution, 0.2%

Intervention Type: DRUG

PATANOL

Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

Group Type: ACTIVE_COMPARATOR

Olopatadine hydrochloride ophthalmic solution, 0.1%

Intervention Type: DRUG

Vehicle

AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14

Group Type: PLACEBO_COMPARATOR

AL-4943A ophthalmic solution vehicle

Intervention Type: DRUG

Interventions

AL-4943A ophthalmic solution

Intervention Type: DRUG

Olopatadine hydrochloride ophthalmic solution, 0.2%

Intervention Type: DRUG

Olopatadine hydrochloride ophthalmic solution, 0.1%

Intervention Type: DRUG

AL-4943A ophthalmic solution vehicle

Intervention Type: DRUG

Other Intervention Names

PATADAY®; PATANOL®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abhijit Narvekar, MS, MBBS

Role: STUDY_DIRECTOR

Alcon Research

References

Carr W, Schaeffer J, Donnenfeld E. Treating allergic conjunctivitis: A once-daily medication that provides 24-hour symptom relief. Allergy Rhinol (Providence). 2016 Jan;7(2):107-14. doi: 10.2500/ar.2016.7.0158. Epub 2016 Jul 26.

Reference Type: DERIVED

PMID: 27466061 (View on PubMed)

McLaurin E, Narvekar A, Gomes P, Adewale A, Torkildsen G. Phase 3 Randomized Double-Masked Study of Efficacy and Safety of Once-Daily 0.77% Olopatadine Hydrochloride Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge Model. Cornea. 2015 Oct;34(10):1245-51. doi: 10.1097/ICO.0000000000000562.

Reference Type: DERIVED

PMID: 26266427 (View on PubMed)

Other Identifiers

C-12-053

Identifier Type: -

Identifier Source: org_study_id