Dehydration of Omafilcon A Contact Lenses Versus Delefilcon A Contact Lenses

July 19, 2020 updated by: Coopervision, Inc.
The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Study Type

Interventional

Enrollment (Actual)

26

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

  • Canada
    • Ontario
      • Waterloo, Ontario, Canada, N2L 3G1
        • University of Waterloo School of Optometry

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

17 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
  5. Is able to wear lenses for at least 12 hours a day.

Exclusion Criteria:

  1. Is participating in any concurrent clinical study;
  2. Has any known active* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

  6. Has undergone refractive error surgery;

    • *For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

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: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: delefilcon A
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
Device: delefilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
Device: omafilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
Experimental: omafilcon A
Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
Device: delefilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
Device: omafilcon A
Each subject randomized to wear either the test or control in either the left of right eye.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A
Time Frame: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
12 Hours of Wear
Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A
Time Frame: 12 Hours of Wear
Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
12 Hours of Wear
Moisture Retention (Mean) of Omafilcon A and Delefilcon A
Time Frame: 12 Hours
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
12 Hours
Moisture Retention (Median) of Omafilcon A and Delefilcon A
Time Frame: 12 Hours
Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
12 Hours

Collaborators and Investigators

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

Sponsor

Coopervision, Inc.

Investigators

  • Principal Investigator: Lydon Jones, PhD FC, Director, Centre for Contact Lens Research
  • Principal Investigator: Farah Panjwani, BSc RAQ, Univerisy of Waterloo

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

March 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 19, 2015

Study Record Updates

Last Update Posted (Actual)

July 31, 2020

Last Update Submitted That Met QC Criteria

July 19, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EX-MKTG-45

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.

Clinical Trials on Myopia

Clinical Trials on delefilcon A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe