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Comparison of CL Wear Between Two Allergy Drops

This study has been withdrawn prior to enrollment.
(Protocol changes)
Sponsor:
Collaborator:
Merck
Information provided by:
Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:
NCT00489398
First received: June 19, 2007
Last updated: October 5, 2010
Last verified: October 2010
History of Changes
  Purpose

Comparison of two allergy drops for enhancing comfort and performance of contact lens wear


Condition Intervention Phase
Allergic Conjunctivitis
 Drug: epinastine HCL and olopatadine HCL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hom, Milton M., OD, FAAO:

Primary Outcome Measures:
  • Contact lens objective and subjective clinical performance testing [ Time Frame: up to 3 months ]

Estimated Enrollment: 25
Study Start Date: July 2007
Estimated Study Completion Date: December 2008
Detailed Description:

Contact lens patients will instill allergy drops and subjective and objective tests will be performed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females > 18 years old
  • Mild to moderate dry eye symptoms
  • Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

  • Current use of topical cyclosporine
  • Known contraindications to any study medication or ingredients
  • Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
  • Ocular surgery within the past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489398

Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Merck
Investigators
Study Director: Milton M Hom, OD FAAO Private Practice
  More Information

No publications provided

Responsible Party: Milton M. Hom, OD, FAAO.
ClinicalTrials.gov Identifier: NCT00489398     History of Changes
Other Study ID Numbers: 5316
Study First Received: June 19, 2007
Last Updated: October 5, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Epinastine
Olopatadine
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Anti-Allergic Agents
Therapeutic Uses
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 May 16, 2013