Assessing Patient Comfort With Two Different Multi-Purpose Disinfecting Solutions

May 25, 2013 updated by: Milton M. Hom, OD, FAAO., Hom, Milton M., OD, FAAO

Assessing Patient Comfort in Silicone Hydrogel Contact Lenses When Cleaned and Stored in Two Different Multi-Purpose Disinfecting Solutions

Tolerability is compared between two Multi-purpose disinfecting solutions (MPDS).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

According to recent surveys of contact lens fitters, the most prescribed treatments for contact lens dryness are: more frequent replacement schedule (24%), refit into different material (23%), rewetting drops (21%) and change care system (15%). Changing care systems has been a standard treatment for CL discomfort for many years. In the same survey, 30% of practitioners felt there is absolutely no difference among solutions with respect to reducing dryness and discomfort.

The investigators set out to compare the clinical performance of these two solutions: AMO's RevitaLens and Alcon's Opti-Free PureMoist.

Study Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

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
    • Georgia
      • Morrow, Georgia, United States, 30260
        • Kirk L. Smick, OD, FAAO.
    • Kentucky
      • Louisville, Kentucky, United States, 40222
        • Ian Ben Gaddie, 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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Between the ages of 18 and over inclusive.
  2. Males or females
  3. Patient is in generally good & stable overall health.
  4. Patient likely to comply with study guidelines & study visits.
  5. Informed consent signed.
  6. Are willing/able to return for all required study visits.
  7. Are willing/able to follow instructions from the study investigator and his/her staff.
  8. Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

  1. Corneal refractive surgery within 6 months of this study.
  2. Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
  3. 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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RevitaLens
AMO's RevitaLens contact lens solution
Other: RevitaLens
Multi-purpose disinfecting solution
Other Names:
  • AMO's RevitaLens
Other: OptiFree PureMoist
Multi-purpose disinfecting solution
Other Names:
  • Alcon's OptiFree PureMoist MPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported comfort scores with contact lens care systems
Time Frame: 14 days
Comfort measured by questionnaires covering positive and negative attributes of contact lens wear
14 days

Collaborators and Investigators

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

Sponsor

Hom, Milton M., OD, FAAO

Collaborators

Abbott Medical Optics

Investigators

  • Principal Investigator: Milton M Hom, OD FAAO

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

June 1, 2013

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

May 1, 2013

First Posted (Estimate)

May 6, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 25, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 12-GHS Comfort Study

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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