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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

January 2, 2009
January 5, 2009
January 2009
June 2009   (final data collection date for primary outcome measure)
Wearing time [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00817557 on ClinicalTrials.gov Archive Site
OSDI [ Time Frame: 28 days ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Contact Lenses Dryness
  • Drug: Loteprednol
    Anti-inflammatory
  • 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.
 
Enrolling by invitation
25
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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817557
05
Yes
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