Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

NCT01479374 | Completed Phase 3 Results

• 1 other identifier: C-10-126
• Study Type: interventional
• Target: 397
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess the safety and efficacy of AL-4943A 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; Ocular Allergy

Outcome Measures

Primary Outcomes (2)

• Mean Ocular Itching at Onset of Action

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

  3, 5, and 7 minute timepoints, post-CAC on Day 21 of receiving treatment

• Mean Ocular Itching at 16 Hours Duration of Action

  A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=incapacitating itch). Average of ocular itching score over both eyes was analyzed.

  3, 5, and 7 minute timepoints, post-CAC on Day 14 of receiving treatment

Secondary Outcomes (5)

• Mean Conjunctival Redness at Onset of Action

  7, 15, and 20 minute timepoints, post-CAC on Day 21 of receiving treatment

• Mean Conjunctival Redness at 16 Hours Duration of Action

  7, 15, and 20 minute timepoints, post-CAC on Day 14 of receiving treatment

• Mean Total Redness at 24 Hours Duration of Action

  7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment

• Mean Ocular Itching at 24 Hours Duration of Action

  3, 5, and 7 minute timepoints, post-CAC on Day 1 of receiving treatment

• Mean Conjunctival Redness at 24 Hours Duration of Action

  7, 15, and 20 minute timepoints, post-CAC on Day 1 of receiving treatment

Study Arms (3)

AL-4943A

EXPERIMENTAL

AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days

Drug: AL-4943A ophthalmic solution

Vehicle

PLACEBO COMPARATOR

AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days

Drug: AL-4943A vehicle

Pataday

ACTIVE COMPARATOR

Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days

Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%

Interventions

AL-4943A ophthalmic solution DRUG

AL-4943A

AL-4943A vehicle DRUG

Inactive ingredients used as placebo

Vehicle

Olopatadine hydrochloride ophthalmic solution, 0.2% DRUG

Also known as: PATADAY®

Pataday

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.
• Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
• History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
• Positive bilateral CAC response at Visit 1 and Visit 2.
• 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 requiring frequent use (\> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
• Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
• Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
• Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
• Any contraindications or hypersensitivities to the use of the study medication or their components.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• 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

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: Abhijit Narvekar, MS, MBBS
• 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2011
• First Posted: November 24, 2011
• Study Start: January 1, 2012
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: June 4, 2013
• Results First Posted: May 23, 2013

Record last verified: 2013-05