Evaluation of Stenfilcon A Versus Etafilcon A

NCT01809834 | Completed Results

• 1 other identifier: CV-12-57
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of two contact lenses

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• Participant's Subjective Rating of Comfort (Questionnaire)

  Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week

  Insertion, After Lens settling, 12-hours, 1-week

• Participant's Subjective Rating of Dryness (Questionnaire)

  Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week

  12-hours, 1-week

• Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)

  Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing

  Dispense

• Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)

  Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week

  12-hours, 1-week

• Participant's Subjective Rating of Visual Quality (Questionnaire)

  Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week

  12-hours, 1-week

• Participant's Subjective Rating of Overall Preference (Questionnaire)

  Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week

  12-hours, 1-week

Secondary Outcomes (6)

• Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)

  Insertion, 12 hours, 1 week

• Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)

  Insertion, 12 hours, 1 week

• Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)

  Insertion

• Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)

  Insertion, 12-hours, 1-week

• Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)

  Baseline, 12-hours, 1-week

Study Arms (2)

Etafilcon A

ACTIVE COMPARATOR

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Device: Stenfilcon A

Stenfilcon A

EXPERIMENTAL

Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously

Device: Etafilcon A

Interventions

Etafilcon A DEVICE

Stenfilcon A

Stenfilcon A DEVICE

Etafilcon A

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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 correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses;
• Has astigmatism less than or equal to -1.00D;
• Is an adapted soft contact lens wearer;
• Demonstrates an acceptable fit with the study lenses;
• Has no active anterior segment disease or known ocular disease.

You may not qualify if:

• A person will be excluded from the study if he/she:
• Has never worn contact lenses before;
• Has any systemic disease affecting ocular health;
• Is using any systemic or topical medications that will affect ocular health;
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses;
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye;
• Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
• Is aphakic;
• Has undergone corneal refractive surgery;
• Is participating in any other type of clinical or research study;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Limitations and Caveats

One participant temporarily discontinued after 12-hour visit. (Primary outcome 1 and 4,1-week visit, n=43)

Results Point of Contact

• Title: Lyndon Jones, PhD, FCO
• Organization: School of Optometry, University of Waterloo

ljones@uwaterloo.ca

519-888-4742

Study Officials

• Lyndon Jones, PhD., FCO

  Univeristy of Waterloo, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2013
• First Posted: March 13, 2013
• Study Start: November 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 28, 2020
• Results First Posted: June 27, 2014

Record last verified: 2020-07

Locations

CA (1)