NCT01699750

Brief Summary

The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
109

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

October 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 8, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

October 2, 2012

Results QC Date

December 1, 2014

Last Update Submit

December 3, 2014

Conditions

MyopiaAstigmatismRefractive Error

Keywords

contact lensescontact lens solutionmyopiaastigmatism

Outcome Measures

Primary Outcomes (1)

  • Mean Ex-Vivo Total Lipid Uptake Per Lens

    The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.

    Day 30

Secondary Outcomes (6)

  • Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)

    Day 30

  • LogMAR Time-Controlled Visual Acuity (TCVA)

    Day 30

  • Overall Comfort Measured With Visual Analog Scale (VAS)

    Day 30

  • Overall Dryness Measured With Visual Analog Scale (VAS)

    Day 30

  • Average Exposure Speed

    Day 30

  • +1 more secondary outcomes

Study Arms (2)

Air Optix Aqua

EXPERIMENTAL

Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each

Device: Lotrafilcon B contact lensesDevice: OPTI-FREE® PUREMOIST® MPDSDevice: BIOTRUE®Device: Balafilcon A contact lensesDevice: ReNu® Multiplus®

Acuvue Oasys

ACTIVE COMPARATOR

Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each

Device: Senofilcon A contact lensesDevice: OPTI-FREE® PUREMOIST® MPDSDevice: BIOTRUE®Device: Balafilcon A contact lensesDevice: ReNu® Multiplus®

Interventions

Lotrafilcon B contact lensesDEVICE

Silicone hydrogel contact lenses, Phase 2

Also known as: AIR OPTIX® AQUA, AOA
Air Optix Aqua
Senofilcon A contact lensesDEVICE

Silicone hydrogel contact lenses, Phase 2

Also known as: ACUVUE® OASYS® with HYDRACLEAR®, AVO
Acuvue Oasys
OPTI-FREE® PUREMOIST® MPDSDEVICE

Contact lens care system, Phase 2

Also known as: OFPM
Acuvue OasysAir Optix Aqua
BIOTRUE®DEVICE

Contact lens care system, Phase 2

Acuvue OasysAir Optix Aqua
Balafilcon A contact lensesDEVICE

Silicone hydrogel contact lenses worn for 30 days, Phase 1

Also known as: PureVision
Acuvue OasysAir Optix Aqua
ReNu® Multiplus®DEVICE

Contact lens care system used for 30 days, Phase 1

Acuvue OasysAir Optix Aqua

Eligibility Criteria

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

You may qualify if:

  • Read and understand the Participant Information Sheet;
  • Read, sign, and date the Informed Consent;
  • Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
  • Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
  • Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
  • Best corrected visual acuity of 6/9 or better in each eye;
  • Normal eyes with the exception of the need for visual correction;

You may not qualify if:

  • Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
  • Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
  • Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
  • Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
  • Systemic or ocular allergies which might interfere with contact lens wear;
  • Ocular disease which might interfere with contact lens wear;
  • Active ocular infection;
  • Use of any concomitant topical ocular medications during the study period;
  • Previous ocular surgery;
  • Pregnant, planning to become pregnant, or lactating at the time of enrollment;
  • Participation in an investigational drug or device study within 30 days of entering this study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center at 1-888-451-3937 for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

MyopiaAstigmatismRefractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

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

Study Officials

  • Jami Kern, 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
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2012

First Posted

October 4, 2012

Study Start

December 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 8, 2014

Results First Posted

December 8, 2014

Record last verified: 2014-12

Locations

US(1)