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Use of Loteprednol for Contact Lens Intolerance and Dryness

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by:
Hom, Milton M., OD, FAAO
ClinicalTrials.gov Identifier:
NCT00817557
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009
History of Changes
  Purpose

Study of the effects of Loteprednol on CL dryness


Condition Intervention Phase
Contact Lenses Dryness
 Drug: Loteprednol
Other: Rewetter
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Use of Loteprednol for Contact Lens Intolerance and Dryness

Resource links provided by NLM:

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

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

Primary Outcome Measures:
  • Wearing time [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • OSDI [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: January 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Loteprednol
Loteprednol BID
 Drug: Loteprednol
Anti-inflammatory
Placebo Comparator: Rewetter
Rewetter BID
 Other: Rewetter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Milton M. Hom, OD, FAAO., Private Practice
ClinicalTrials.gov Identifier: NCT00817557     History of Changes
Other Study ID Numbers: 05
Study First Received: January 2, 2009
Last Updated: January 5, 2009
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Loteprednol etabonate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013