Comparison of CL Wear Between Two Allergy Drops

This study has been withdrawn prior to enrollment.

( Protocol changes )

First Received on June 19, 2007. Last Updated on October 5, 2010 History of Changes

Sponsor:	Hom, Milton M., OD, FAAO
Collaborator:	Merck
Information provided by:	Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:	NCT00489398

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 IV

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:

MedlinePlus related topics: Allergy Eye Wear Pinkeye

Drug Information available for: Epinastine Epinastine hydrochloride Olopatadine Patanol

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 February 09, 2012