NCT01839318

Brief Summary

The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 20, 2014

Completed
Last Updated

June 20, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

April 22, 2013

Results QC Date

May 21, 2014

Last Update Submit

May 21, 2014

Conditions

MyopiaHyperopiaRefractive Error

Keywords

Soft contact lensesDaily disposable contact lensesTear Film Break Up TimeContact lens wettability

Outcome Measures

Primary Outcomes (1)

  • Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours

    The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.

    Hour 8

Secondary Outcomes (1)

  • Total Wettability Score

    Hour 8

Study Arms (3)

DAILIES AquaComfort Plus

EXPERIMENTAL

Nelfilcon A contact lenses worn first, followed by etafilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.

Device: Nelfilcon A contact lenses

1-DAY ACUVUE MOIST

ACTIVE COMPARATOR

Etafilcon A contact lenses worn first, followed by nelfilcon A and omafilcon A in randomized order. Each product worn for 1 day, 12 hours.

Device: Etafilcon A contact lenses

Proclear 1 day

ACTIVE COMPARATOR

Omafilcon A contact lenses worn first, followed by etafilcon A and nelfilcon A in randomized order. Each product worn for 1 day, 12 hours.

Device: Omafilcon A contact lenses

Interventions

Nelfilcon A contact lensesDEVICE
Also known as: DAILIES® AquaComfort Plus®
DAILIES AquaComfort Plus
Omafilcon A contact lensesDEVICE
Also known as: Proclear® 1 day
Proclear 1 day
Etafilcon A contact lensesDEVICE
Also known as: 1-DAY ACUVUE® MOIST®
1-DAY ACUVUE MOIST

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Sign Informed Consent.
  • Adapted soft contact lens wearer.
  • Willing to wear contact lenses up to 12 hours and attend all study visits.
  • Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
  • Contact lens prescription within the power range specified in the protocol.

You may not qualify if:

  • Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
  • Any use of systemic or ocular medications that would contraindicate contact lens wear.
  • Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
  • Monocular (only 1 eye with functional vision) or fit with only 1 lens.
  • History of herpetic keratitis, ocular surgery, or irregular cornea.
  • Known pregnancy.
  • Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
  • Participation in any clinical study within 30 days of Visit 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

MyopiaHyperopiaRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title
Jessie Lemp, GMA Brand Lead
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Jessie Lemp, PhD

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2013

First Posted

April 24, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 20, 2014

Results First Posted

June 20, 2014

Record last verified: 2014-05