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Clinical Trials/NCT02298400
NCT02298400WithdrawnNot Applicable

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™

ORA, Inc.1 site in 1 countryStarted: August 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Contact lens wear comfort, as assessed by subject reported symptoms in diaries.

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Clariti® 1-Day (Somofilcon A)

Active Comparator

Clariti® 1-Day (Somofilcon A) contact lenses

Intervention: 30-Day Bausch + Lomb PureVision (balafilcon A) (Device)

Acuvue®Oasys® Lenses(senofilcon A)

Active Comparator

Acuvue® Oasys® Lenses (senofilcon A) contact lenses

Intervention: Acuvue® Oasys® Lenses (senofilcon A) (Device)

Acuvue®Oasys® Lenses(senofilcon A)

Active Comparator

Acuvue® Oasys® Lenses (senofilcon A) contact lenses

Intervention: 30-Day Bausch + Lomb PureVision (balafilcon A) (Device)

Acuvue®Oasys® Lenses(senofilcon A)

Active Comparator

Acuvue® Oasys® Lenses (senofilcon A) contact lenses

Intervention: Clariti® 1-Day (Somofilcon A) (Device)

Bausch + Lomb PureVision (balafilcon A)

Active Comparator

30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses

Intervention: Acuvue® Oasys® Lenses (senofilcon A) (Device)

Bausch + Lomb PureVision (balafilcon A)

Active Comparator

30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses

Intervention: 30-Day Bausch + Lomb PureVision (balafilcon A) (Device)

Bausch + Lomb PureVision (balafilcon A)

Active Comparator

30-Day Bausch + Lomb PureVision (balafilcon A) contact lenses

Intervention: Clariti® 1-Day (Somofilcon A) (Device)

Clariti® 1-Day (Somofilcon A)

Active Comparator

Clariti® 1-Day (Somofilcon A) contact lenses

Intervention: Acuvue® Oasys® Lenses (senofilcon A) (Device)

Clariti® 1-Day (Somofilcon A)

Active Comparator

Clariti® 1-Day (Somofilcon A) contact lenses

Intervention: Clariti® 1-Day (Somofilcon A) (Device)

Outcomes

Primary Outcomes

Contact lens wear comfort, as assessed by subject reported symptoms in diaries.

Time Frame: 1 week

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
ORA, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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