Text Size

Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01435460
First received: September 14, 2011
Last updated: February 17, 2012
Last verified: February 2012
History of Changes
  Purpose

This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).


Condition Intervention Phase
Seasonal Allergic Conjunctivitis
 Drug: Loteprednol etabonate 0.2%
Drug: Olopatadine 0.1%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Safety and Efficacy Evaluation of Alrex® (Loteprednol Etabonate Ophthalmic Suspension, 0.2%) Versus Patanol (Olopatadine Hydrochloride Ophthalmic Solution, 0.1%) in the Treatment of Seasonal Allergic Conjunctivitis (SAC)

Resource links provided by NLM:

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

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Bulbar Conjunctival Injection [ Time Frame: Change from baseline to day 15 (visit 3) ] [ Designated as safety issue: No ]
    Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe

  • Ocular Itching [ Time Frame: Change from baseline to day 15 (visit 3) ] [ Designated as safety issue: No ]
    Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe


Secondary Outcome Measures:
  • Bulbar Conjunctival Injection [ Time Frame: Change from baseline to day 8 (visit 2) ] [ Designated as safety issue: No ]
    Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe

  • Ocular Itching [ Time Frame: Change from baseline to day 8 (visit 2) ] [ Designated as safety issue: No ]
    Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe


Enrollment: 300
Study Start Date: August 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alrex
Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
 Drug: Loteprednol etabonate 0.2%
1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
Other Name: Alrex
Active Comparator: Patanol
Ophthalmic solution containing olopatadine, 0.1%
 Drug: Olopatadine 0.1%
1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
Other Name: Patanol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.

Exclusion Criteria:

  • Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
  • Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
  • Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
  • Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435460

Locations
Singapore
Bausch & Lomb Singapore
Singapore, Singapore, 556741
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Esther Chu Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01435460     History of Changes
Other Study ID Numbers: 634
Study First Received: September 14, 2011
Results First Received: February 17, 2012
Last Updated: February 17, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
ocular allergy

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

ClinicalTrials.gov processed this record on June 18, 2013