NCT02495948

Brief Summary

The purpose of this study is to evaluate cholesterol sorption by AIR OPTIX® AQUA lenses compared to ULTRA lenses after 30 days of wear.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 19, 2016

Completed
Last Updated

December 28, 2016

Status Verified

November 1, 2016

Enrollment Period

3 months

First QC Date

July 9, 2015

Results QC Date

August 25, 2016

Last Update Submit

November 7, 2016

Conditions

Refractive Error

Outcome Measures

Primary Outcomes (1)

  • Mean Ex-vivo Cholesterol Deposits After 30 Days of Wear

    The contact lens (right eye) was removed and stored dry and frozen until analysis. Total cholesterol deposits (cholesterol and cholesterol esters) were extracted from the lens and measured in micrograms. Lower deposits indicate increased lens performance. Study originally intended to analyze 36 lenses per arm, but actual number of lenses analyzed was less due to measurement error.

    Day 30, each product

Study Arms (2)

AOA then ULTRA

OTHER

Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.

Device: Lotrafilcon B contact lensesDevice: Samfilcon A contact lensesDevice: Hydrogen peroxide solutionDevice: Saline solution

ULTRA then AOA

OTHER

Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.

Device: Lotrafilcon B contact lensesDevice: Samfilcon A contact lensesDevice: Hydrogen peroxide solutionDevice: Saline solution

Interventions

Lotrafilcon B contact lensesDEVICE
Also known as: AIR OPTIX® AQUA
AOA then ULTRAULTRA then AOA
Samfilcon A contact lensesDEVICE
Also known as: Bausch + Lomb ULTRA
AOA then ULTRAULTRA then AOA
Hydrogen peroxide solutionDEVICE

Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses

Also known as: CLEAR CARE®
AOA then ULTRAULTRA then AOA
Saline solutionDEVICE

Used for rinsing contact lenses, as needed

Also known as: SENSITIVE EYES® PLUS
AOA then ULTRAULTRA then AOA

Eligibility Criteria

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

You may qualify if:

  • Sign informed consent document;
  • Vision correctable to 20/40 Snellen (feet) or better in each eye at distance with both study contact lenses;
  • Willing to wear study lenses on a daily basis (minimum 5 days/week, 8 hours/day) and attend all study visits;
  • Successful wear of single-vision spherical, 2-week/ monthly replacement silicone hydrogel contact lenses in both eyes daily wear during the past 2 months for a minimum of 5 days/week, 8 hours/day. (Note: Monovision is included);

You may not qualify if:

  • Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current);
  • History of herpetic keratitis, corneal surgery or irregular cornea;
  • Any use of systemic or ocular medications within the past 30 days for which contact lens wear could be contraindicated as determined by the investigator;
  • Monocular (only 1 eye with functional vision) or fit with only one lens;
  • Current or past AIR OPTIX® AQUA or ULTRA lens wearers;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Refractive Errors

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Global Medical Affairs Brand Lead, Vision Care
Organization
Alcon, A Novartis Division
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Clinical Trial Manager, Vision Care, GCRA

    Alcon, A Novartis Division

    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
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2015

First Posted

July 13, 2015

Study Start

July 1, 2015

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 28, 2016

Results First Posted

October 19, 2016

Record last verified: 2016-11