NCT02366910

Brief Summary

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

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

February 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
12 months until next milestone

Results Posted

Study results publicly available

March 29, 2016

Completed
Last Updated

July 31, 2020

Status Verified

July 1, 2020

Enrollment Period

Same day

First QC Date

February 12, 2015

Results QC Date

January 18, 2016

Last Update Submit

July 19, 2020

Conditions

Myopia

Outcome Measures

Primary Outcomes (4)

  • Absolute Change in Water Content (Mean) of Omafilcon A and Delefilcon A

    Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

    12 Hours of Wear

  • Absolute Change in Water Content (Median) of Omafilcon A and Delefilcon A

    Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

    12 Hours of Wear

  • Moisture Retention (Mean) of Omafilcon A and Delefilcon A

    Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

    12 Hours

  • Moisture Retention (Median) of Omafilcon A and Delefilcon A

    Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).

    12 Hours

Study Arms (2)

omafilcon A

EXPERIMENTAL

Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

Device: omafilcon ADevice: delefilcon A

delefilcon A

ACTIVE COMPARATOR

Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

Device: omafilcon ADevice: delefilcon A

Interventions

omafilcon ADEVICE

Each subject randomized to wear either the test or control in either the left of right eye.

delefilcon Aomafilcon A
delefilcon ADEVICE

Each subject randomized to wear either the test or control in either the left of right eye.

delefilcon Aomafilcon A

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Is at least 17 years of age and has full legal capacity to volunteer;
  • Has read and signed an information consent letter;
  • Is willing and able to follow instructions and maintain the appointment schedule;
  • Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
  • Is able to wear lenses for at least 12 hours a day.

You may not qualify if:

  • Is participating in any concurrent clinical study;
  • Has any known active\* ocular disease and/or infection;
  • Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  • Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  • Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  • Has undergone refractive error surgery;
  • \*For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo School of Optometry

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Jose A. Vega, OD, Sr. Manager Global Medical Scientific Affairs
Organization
Coopervision
jvega@coopervision.com
(925) 621-3761

Study Officials

  • Lydon Jones, PhD FC

    Director, Centre for Contact Lens Research

    PRINCIPAL INVESTIGATOR

  • Farah Panjwani, BSc RAQ

    Univerisy of Waterloo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

February 12, 2015

First Posted

February 19, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

July 31, 2020

Results First Posted

March 29, 2016

Record last verified: 2020-07

Locations

CA(1)