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Use of Loteprednol for Contact Lens Intolerance and Dryness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Hom, Milton M., OD, FAAO.
Recruitment status was:  Enrolling by invitation
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
  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
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:


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

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

Secondary Outcome Measures:
  • OSDI [ Time Frame: 28 days ]

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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Loteprednol Etabonate
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 24, 2017