A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis

NCT01470118 | Completed Phase 4 Results

• 1 other identifier: GMA-LAS-011-001
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.

Conditions

Conjunctivitis, Allergic

Outcome Measures

Primary Outcomes (2)

• Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16

  Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

  Day 0 Hour 16

• Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24

  Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

  Day 14 Hour 24

Secondary Outcomes (6)

• Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

  Day 14 Hour 24

• Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

  Day 14 Hour 24

• Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

  Day 14 Hour 24

• Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

  Day 14 Hour 24

• Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24

  Day 14 Hour 24

Study Arms (3)

LASTACAFT® (alcaftadine 0.25%)

ACTIVE COMPARATOR

One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Drug: alcaftadine 0.25% ophthalmic solution

Pataday™ (olopatadine 0.2%)

ACTIVE COMPARATOR

One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Drug: olopatadine 0.2% ophthalmic solution

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

PLACEBO COMPARATOR

One drop of placebo instilled in each eye at Day 0 and Day 14.

Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

Interventions

alcaftadine 0.25% ophthalmic solution DRUG

One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Also known as: LASTACAFT®

LASTACAFT® (alcaftadine 0.25%)

olopatadine 0.2% ophthalmic solution DRUG

One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Also known as: Pataday™

Pataday™ (olopatadine 0.2%)

dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% DRUG

One drop of placebo instilled in each eye at Day 0 and Day 14.

Also known as: Tears Naturale® II Artificial Tears

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 eye allergies within the past 24 months
• Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

You may not qualify if:

• Current eye infection
• Eye surgery within 3 months or vision correction surgery within 6 months
• Any planned surgery during the study or 30 days after the study

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 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; Ophthalmic Solutions; Olopatadine Hydrochloride; Dextrans

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates

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 9, 2011
• First Posted: November 11, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 21, 2013
• Results First Posted: February 21, 2013

Record last verified: 2013-01

Locations

US (1)