Use of Loteprednol for Contact Lens Intolerance and Dryness

January 5, 2009 updated by: Hom, Milton M., OD, FAAO
Study of the effects of Loteprednol on CL dryness

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Azusa, California, United States, 91702
        • Milton M. Hom, OD, FAAO.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Loteprednol
Loteprednol BID
Drug: Loteprednol
Anti-inflammatory
Placebo Comparator: Rewetter
Rewetter BID
Other: Rewetter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wearing time
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
OSDI
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hom, Milton M., OD, FAAO

Collaborators

Bausch & Lomb Incorporated

Investigators

  • Principal Investigator: Milton M Hom, OD FAAO, Private Practice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

January 2, 2009

First Submitted That Met QC Criteria

January 5, 2009

First Posted (Estimate)

January 6, 2009

Study Record Updates

Last Update Posted (Estimate)

January 6, 2009

Last Update Submitted That Met QC Criteria

January 5, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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