Overall Performance of a 1-day Silicone Hydrogel Lens When Habitual Soft Lens Wearers Are Refit

NCT02588573 | Completed Results

• 1 other identifier: EX-MKTG-61
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• Comfort

  Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.

  8 hours

• Comfort Preference

  Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens

  Baseline and 8 hours

• Bulbar Hyperemia

  Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.

  Baseline and 8 hours

• Limbal Hyperemia

  Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.

  Baseline and 8 hours

• Conjunctival Staining

  Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central

  8 hours

• Visual Acuity

  High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.

  Baseline and 8 hours

Study Arms (2)

Etafilcon A (control)

ACTIVE COMPARATOR

Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.

Device: etafilcon A (control); Device: somofilcon A (test)

Somofilcon A (test)

ACTIVE COMPARATOR

Subjects in each of the habitual wearing groups will be randomized to wear either the test or control lens in either the left or right eye.

Device: etafilcon A (control); Device: somofilcon A (test)

Interventions

etafilcon A (control) DEVICE

contact lens

Etafilcon A (control); Somofilcon A (test)

somofilcon A (test) DEVICE

contact lens

Etafilcon A (control); Somofilcon A (test)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 20/40 or better (in each eye) with their habitual correction or the assigned study lenses;
• Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);
• Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;
• Demonstrates an acceptable fit with the study lenses;
• Is usually able to wear contact lenses for at least 8 hours per day.

You may not qualify if:

• A person will be excluded from the study if he/she:
• Is participating in any concurrent clinical or research 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 substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;
• Is aphakic;
• Has undergone refractive error surgery.
• Has participated in the previous somfofilcon A study (ORE# 20893)
• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (2)

Center for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

University of Waterloo

Waterloo, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Senior Manager Global Medical Scientific Affairs
• Organization: CooperVision Inc.

javega@coopervision.com

925 621-3761

Study Officials

• Lyndon Jones, PhD, FCOptom

  Centre for Contact Lens Research

  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: October 22, 2015
• First Posted: October 28, 2015
• Study Start: October 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: February 8, 2019
• Results First Posted: February 8, 2019

Record last verified: 2019-02

Locations

CA (2)