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Use of Loteprednol for Contact Lens Intolerance and Dryness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by:

January 2, 2009
January 6, 2009
January 6, 2009
January 2009
June 2009   (Final data collection date for primary outcome measure)
Wearing time [ Time Frame: 28 days ]
Same as current
No Changes Posted
OSDI [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
Use of Loteprednol for Contact Lens Intolerance and Dryness
Use of Loteprednol for Contact Lens Intolerance and Dryness
Study of the effects of Loteprednol on CL dryness
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Contact Lenses Dryness
  • Drug: Loteprednol
  • Other: Rewetter
  • Active Comparator: Loteprednol
    Loteprednol BID
    Intervention: Drug: Loteprednol
  • Placebo Comparator: Rewetter
    Rewetter BID
    Intervention: Other: Rewetter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
September 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Milton M. Hom, OD, FAAO., Private Practice
Hom, Milton M., OD, FAAO
Bausch & Lomb Incorporated
Principal Investigator: Milton M Hom, OD FAAO Private Practice
Hom, Milton M., OD, FAAO
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP