A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis

NCT01732757 | Completed Phase 4 Results

• 1 other identifier: GMA-LAS-12-023
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.

Conditions

Conjunctivitis, Allergic

Outcome Measures

Primary Outcomes (1)

• Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0

  Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.

  Day 0 at 3 Minutes Post Challenge

Secondary Outcomes (10)

• Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0

  Day 0

• Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0

  Day 0

• Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0

  Day 0

• Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0

  Day 0

• Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0

  Day 0

Study Arms (3)

Lastacaft®

ACTIVE COMPARATOR

One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.

Drug: Alcaftadine 0.25%

Pataday™

ACTIVE COMPARATOR

One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.

Drug: Olopatadine 0.2%

Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)

PLACEBO COMPARATOR

One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

Interventions

Alcaftadine 0.25% DRUG

One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.

Also known as: Lastacaft®

Lastacaft®

Olopatadine 0.2% DRUG

One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.

Also known as: Pataday™

Pataday™

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% DRUG

One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Also known as: Tears Naturale II

Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• History of ocular allergies within the past 24 months.
• Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.

You may not qualify if:

• Any presence of active ocular infection or history of an ocular herpetic infection.
• Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
• Have any planned surgery during the study or 30 days after the study.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Memphis, Tennessee, United States

Location

Related Publications (1)

• McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA. Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials. Adv Ther. 2014 Oct;31(10):1059-71. doi: 10.1007/s12325-014-0155-3. Epub 2014 Sep 27.

  PMID: 25260889 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

alcaftadine; Olopatadine Hydrochloride; Dextrans; Lubricant Eye Drops

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; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 26, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2014
• Results First Posted: January 14, 2014

Record last verified: 2013-11

Locations

US (1)