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Use of Loteprednol for Contact Lens Intolerance and Dryness

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ClinicalTrials.gov Identifier: NCT00817557
Recruitment Status : Unknown
Verified January 2009 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
First Posted : January 6, 2009
Last Update Posted : January 6, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Study of the effects of Loteprednol on CL dryness

Condition or disease Intervention/treatment Phase
Contact Lenses Dryness Drug: Loteprednol Other: Rewetter Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Use of Loteprednol for Contact Lens Intolerance and Dryness
Study Start Date : January 2009
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Loteprednol
Loteprednol BID
Drug: Loteprednol
Anti-inflammatory
Placebo Comparator: Rewetter
Rewetter BID
Other: Rewetter


Outcome Measures

Primary Outcome Measures :
  1. Wearing time [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. OSDI [ Time Frame: 28 days ]

Eligibility Criteria

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:

  1. Between the ages of 18 and over inclusive.
  2. Males or females
  3. Any race or ethnic background
  4. CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.
  5. Patient is in generally good & stable overall health.
  6. Patient likely to comply with study guidelines & study visits.
  7. Informed consent signed.
  8. OSDI score 18 or higher while wearing lenses
  9. Unsatisfactory wearing time with contact lenses

Exclusion Criteria:

  1. Corneal refractive surgery within 6 months of this study.
  2. Contact lens use on day of examination.
  3. Corneal ectasia.
  4. Current use of Restasis
  5. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
  6. Pregnant or lactating women.
  7. Ocular pathology (includes glaucoma and cataract) which could impact results and/or place patient at risk.
Contacts and Locations

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): NCT00817557


Locations
United States, California
Milton M. Hom, OD, FAAO.
Azusa, California, United States, 91702
Sponsors and Collaborators
Hom, Milton M., OD, FAAO
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Milton M Hom, OD FAAO Private Practice
More Information

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT00817557     History of Changes
Other Study ID Numbers: 05
First Posted: January 6, 2009    Key Record Dates
Last Update Posted: January 6, 2009
Last Verified: January 2009

Keywords provided by Hom, Milton M., OD, FAAO:
Contact lenses
Loteprednol
Effect on CL dryness

Additional relevant MeSH terms:
Loteprednol Etabonate
Anti-Allergic Agents