NCT02298400

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

November 17, 2014

Last Update Submit

April 23, 2024

Conditions

Contact Lens Complication

Outcome Measures

Primary Outcomes (1)

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

    1 week

Study Arms (3)

Acuvue®Oasys® Lenses(senofilcon A)

ACTIVE COMPARATOR

Acuvue® Oasys® Lenses (senofilcon A) contact lenses

Device: Acuvue® Oasys® Lenses (senofilcon A)Device: 30-Day Bausch + Lomb PureVision (balafilcon A)Device: Clariti® 1-Day (Somofilcon A)

Bausch + Lomb PureVision (balafilcon A)

ACTIVE COMPARATOR

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

Device: Acuvue® Oasys® Lenses (senofilcon A)Device: 30-Day Bausch + Lomb PureVision (balafilcon A)Device: Clariti® 1-Day (Somofilcon A)

Clariti® 1-Day (Somofilcon A)

ACTIVE COMPARATOR

Clariti® 1-Day (Somofilcon A) contact lenses

Device: Acuvue® Oasys® Lenses (senofilcon A)Device: 30-Day Bausch + Lomb PureVision (balafilcon A)Device: Clariti® 1-Day (Somofilcon A)

Interventions

Acuvue® Oasys® Lenses (senofilcon A)DEVICE

Contact lenses placed in each eye during the day for about 8 hours

Acuvue®Oasys® Lenses(senofilcon A)Bausch + Lomb PureVision (balafilcon A)Clariti® 1-Day (Somofilcon A)
30-Day Bausch + Lomb PureVision (balafilcon A)DEVICE

Contact lenses placed in each eye during the day for about 8 hours

Acuvue®Oasys® Lenses(senofilcon A)Bausch + Lomb PureVision (balafilcon A)Clariti® 1-Day (Somofilcon A)
Clariti® 1-Day (Somofilcon A)DEVICE

Contact lenses placed in each eye during the day for about 8 hours

Acuvue®Oasys® Lenses(senofilcon A)Bausch + Lomb PureVision (balafilcon A)Clariti® 1-Day (Somofilcon A)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

November 24, 2014

Study Start

August 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations

US(1)