A Clinical Study Comparing the Comfort of Three Commercially Available Contact Lenses

April 23, 2024 updated by: ORA, Inc.

A Single-Center, Cross-over, Pilot Study Evaluating Acuvue® Oasys® Lenses (Senofilcon A), 30-Day Bausch + Lomb PureVision (Balafilcon A), and Clariti® 1-Day (Somofilcon A) Lenses, for Their Impact on Ocular Discomfort Induced by Exposure to the Turbo Controlled Adverse Environment™

The purpose of this study is to compare the comfort of three commercially available contact lenses.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Andover Eye Associates

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

Description

Inclusion Criteria:

  • Be at least 18 years old
  • Have provided written informed consent
  • Have discomfort when wearing contact lenses

Exclusion Criteria:

  • Have an active ocular infection or significant slit lamp findings
  • Participated in any other studies in the past 30 days

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acuvue®Oasys® Lenses(senofilcon A)
Acuvue® Oasys® Lenses (senofilcon A) contact lenses
Device: Acuvue® Oasys® Lenses (senofilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Device: 30-Day Bausch + Lomb PureVision (balafilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Device: Clariti® 1-Day (Somofilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Active Comparator: Bausch + Lomb PureVision (balafilcon A)
30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses
Device: Acuvue® Oasys® Lenses (senofilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Device: 30-Day Bausch + Lomb PureVision (balafilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Device: Clariti® 1-Day (Somofilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Active Comparator: Clariti® 1-Day (Somofilcon A)
Clariti® 1-Day (Somofilcon A) contact lenses
Device: Acuvue® Oasys® Lenses (senofilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Device: 30-Day Bausch + Lomb PureVision (balafilcon A)
Contact lenses placed in each eye during the day for about 8 hours
Device: Clariti® 1-Day (Somofilcon A)
Contact lenses placed in each eye during the day for about 8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Contact lens wear comfort, as assessed by subject reported symptoms in diaries.
Time Frame: 1 week
1 week

Collaborators and Investigators

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

Sponsor

ORA, Inc.

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 (Actual)

August 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 17, 2014

First Submitted That Met QC Criteria

November 19, 2014

First Posted (Estimated)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 14-270-0001

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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