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Comparison of CL Wear Between Two Allergy Drops

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ClinicalTrials.gov Identifier: NCT00489398
Recruitment Status : Withdrawn (Protocol changes)
First Posted : June 21, 2007
Last Update Posted : October 7, 2010
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Hom, Milton M., OD, FAAO

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

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: epinastine HCL and olopatadine HCL Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride
Study Start Date : July 2007
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489398


Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Merck Sharp & Dohme Corp.
Investigators
Study Director: Milton M Hom, OD FAAO Private Practice

Responsible Party: Milton M. Hom, OD, FAAO.
ClinicalTrials.gov Identifier: NCT00489398     History of Changes
Other Study ID Numbers: 5316
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: October 2010

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