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

NCT01743027 | Completed Phase 3 Results

• 1 other identifier: C-12-053
• Study Type: interventional
• Target: 902
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Conjunctivitis

Keywords

Allergic conjunctivitis; Olopatadine HCl solution; Conjunctival Allergen Challenge; Itching eyes; Ocular allergies; PATADAY; PATANOL

Outcome Measures

Primary Outcomes (2)

• Mean Ocular Itching at Onset of Action

  A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.

  Day 14 (3, 5, and 7 minutes post-CAC)

• Mean Ocular Itching at 24 Hours Duration of Action

  A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.

  Day 1 (3, 5, and 7 minutes post-CAC)

Secondary Outcomes (6)

• Mean Conjunctival Redness at Onset of Action

  Day 14 (7, 15, and 20 minutes post-CAC)

• Mean Conjunctival Redness at 24 Hours Duration of Action

  Day 1 (7, 15, and 20 minutes post-CAC)

• Mean Total Redness at Onset of Action

  Day 14 (7, 15, and 20 minutes post-CAC)

• Mean Total Redness at 24 Hours Duration of Action

  Day 1 (7, 15, and 20 minutes post-CAC)

• Proportion of Ocular Itching Responders at Onset of Action

  Day 14

Study Arms (4)

AL-4943A

EXPERIMENTAL

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

Drug: AL-4943A ophthalmic solution

PATADAY

ACTIVE COMPARATOR

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

Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%

PATANOL

ACTIVE COMPARATOR

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

Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%

Vehicle

PLACEBO COMPARATOR

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

Drug: AL-4943A ophthalmic solution vehicle

Interventions

AL-4943A ophthalmic solution DRUG

AL-4943A

Olopatadine hydrochloride ophthalmic solution, 0.2% DRUG

Also known as: PATADAY®

PATADAY

Olopatadine hydrochloride ophthalmic solution, 0.1% DRUG

Also known as: PATANOL®

PATANOL

AL-4943A ophthalmic solution vehicle DRUG

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (2)

• 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.

  PMID: 27466061 DERIVED

• 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.

  PMID: 26266427 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: James Wheeler, Unit Head, Pharma
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Abhijit Narvekar, MS, MBBS

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 6, 2012
• Study Start: January 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 11, 2014
• Results First Posted: August 11, 2014

Record last verified: 2014-07