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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02588573
• Other study ID #: EX-MKTG-61
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: April 2016

Study information

• Verified date: February 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• A person is eligible for inclusion in the study if he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses;

5. Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1);

6. Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes;

7. Demonstrates an acceptable fit with the study lenses;

8. Is usually able to wear contact lenses for at least 8 hours per day.

Exclusion Criteria:

• A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical or research study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study;

6. Is aphakic;

7. Has undergone refractive error surgery.

8. 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• etafilcon A (control)
contact lens
• somofilcon A (test)
contact lens

Locations

Country	Name	City	State
Canada	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario
Canada	University of Waterloo	Waterloo

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Bulbar Hyperemia	Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.	Baseline and 8 hours
Primary	Limbal Hyperemia	Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.	Baseline and 8 hours
Primary	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
Primary	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