A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: silicone hydrogel lens (test); Device: enfilcon A lens (control)

Detailed Description

The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.

Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

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

• Is at least 17 years of age and has full legal capacity to volunteer
• Has read and understood the 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
• Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

Exclusion Criteria:

-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 pharmaceuticals to be used in the study
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
• Is aphakic
• Has undergone corneal refractive 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. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)

For the purposes of this study, participants will be excluded**, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: silicone hydrogel lens (test); Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.	Device: silicone hydrogel lens (test); contact lens
Active Comparator: enfilcon A lens (control); Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.	Device: enfilcon A lens (control); contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.	Baseline and 1 week
Dryness	Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.	Baseline and 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Wettability	Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.	Baseline and 1 week
Surface Appearance	Grade ratings category (smooth, grainy, or other)	Baseline
Surface Appearance	Grade ratings category (smooth, grainy, or other)	1 week
High Contrast Acuity at High Room Illumination	Logarithm of the Minimum Angle or Resolution (LogMAR) Chart	Baseline and 1 week
Lens Deposition	Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced	Baseline and 1 week
Lens Problems	Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.	Baseline and 1 week
Lens Centration	Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered. (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior	Baseline
Lens Centration	Lens centration was evaluated by the conjunctival overlap to determine whether lens was slightly or excessively decentered. (mm, 0.1 steps) N - Nasal, T - Temporal, S - Superior, I - Interior, N/S - Nasal/Superior, N/I - Nasal/Interior, T/S - Temporal/Superior T/I - Temporal/Interior	1 week
Post-blink Movement	Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)	Baseline and 1 week
Lens Tightness	Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.	Baseline and 1 week
Visual Quality	Subjective ratings scale (0-100): 0=Extremely poor vision all of the time; cannot function, 20=Frequently annoying vision problems, 40=Occasionally annoying vision problems, 60=Occasionally noticeable but not annoying vision problems, 80=Rarely noticeable vision problems, 100=Excellent vision all of the time. Different time points were taken for vision quality: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.	Baseline and 1 week
Ease of Lens Insertion	Subjective ratings scale (0-100): 0=Could not place lens on eye, 20=Frequently takes multiple attempts to place on eye; often unsuccessful, 40=Frequently takes multiple attempts to place on eye, 60=Occasionally takes a few attempts to place on eye, 80=Rarely difficult to place on eye, 100=Always easy to place lens on eye	Baseline and 1 week
Ease of Lens Removal	Subjective ratings scale (0-100): 0=Could not remove lens from eye, 20=Frequently takes multiple attempts to remove from eye; often unsuccessful, 40=Frequently takes multiple attempts to remove from eye, 60=Occasionally takes a few attempts to remove from eye, 80=Rarely difficult to remove from eye, 100=Always easy to remove lens from eye.	1 week
Overall Lens Fit	Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all); Poor (lens could be worn with supervision only);; Fair (would prefer to refit, but clinically acceptable);; Good (fit could be slightly improved);; Very good (optimal)	Baseline and 1 week
Bulbar Hyperemia	Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.	Baseline and 1 week
Limbal Hyperemia	Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.	Baseline and 1 week
Corneal Dehydration Staining	Corneal Staining: Dehydration Staining: Yes/No	1 week
Corneal Staining (Extent)	Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior	Baseline and 1 week
Conjunctival Indentation	Conjunctival Indentation 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4, 0.5 steps; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe	Baseline and 1 week.
Conjunctival Staining	Conjunctival Staining 5 locations (central, nasal, temporal, superior, inferior): Scale 0-4; 0.5 steps, 0=None,1=Minimal diffuse punctuate, 2=Coalescent punctuate, 3=Confluent, 4=Deep confluent	Baseline and 1 week

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, PhD FCO, Center for Contact Lens Research, University of Waterloo

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: CV-15-36