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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01732757
First received: November 19, 2012
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Conjunctivitis, Allergic
 Drug: Alcaftadine 0.25%
Drug: Olopatadine 0.2%
Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Itching Pinkeye
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Ocular Itching on a 5-Point Scale [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eye Redness on a 5-Point Scale [ Time Frame: Day 0 ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lastacaft®
One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
 Drug: Alcaftadine 0.25%
One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
Other Name: Lastacaft®
Active Comparator: Pataday™
One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
 Drug: Olopatadine 0.2%
One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
Other Name: Pataday™
Placebo Comparator: Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)
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%
One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
Other Name: Tears Naturale II

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732757

Locations
United States, Tennessee
Memphis, Tennessee, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01732757     History of Changes
Other Study ID Numbers: GMA-LAS-12-023
Study First Received: November 19, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dextrans
Olopatadine
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Plasma Substitutes
Blood Substitutes
 Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 19, 2013