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

Not Applicable

Completed

Conditions: Myopia

Interventions: Device: silicone hydrogel lens (test)
Device: enfilcon A lens (control)

Registration Number: NCT02500368

Lead Sponsor: Coopervision, Inc.

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

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 41

Inclusion Criteria

Not provided

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
silicone hydrogel lens (test)	silicone hydrogel lens (test)	Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
enfilcon A lens (control)	enfilcon A lens (control)	Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.

Primary Outcome Measures

Name	Time	Method
Comfort	Baseline and 1 week	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.
Dryness	Baseline and 1 week	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.

Secondary Outcome Measures

Name	Time	Method
Lens Wettability	Baseline and 1 week	Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.
Lens Tightness	Baseline and 1 week	Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.
Ease of Lens Removal	1 week	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.
Overall Lens Fit	Baseline and 1 week	Overall Lens Fit Scale 0-4, 0.25 steps 0=Very poor (lens should not be worn at all); 1. Poor (lens could be worn with supervision only); 2. Fair (would prefer to refit, but clinically acceptable); 3. Good (fit could be slightly improved); 4. Very good (optimal)
Lens Problems	Baseline and 1 week	Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.
Post-blink Movement	Baseline and 1 week	Post-blink movement evaluated by estimating the distance the lens was moving immediately after a blink. Primary Gaze: (mm, 0.1 steps)
Bulbar Hyperemia	Baseline and 1 week	Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Visual Quality	Baseline and 1 week	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.
Corneal Dehydration Staining	1 week	Corneal Staining: Dehydration Staining: Yes/No
Lens Deposition	Baseline and 1 week	Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced
Lens Centration	1 week	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
Ease of Lens Insertion	Baseline and 1 week	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
Corneal Staining (Extent)	Baseline and 1 week	Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior
Conjunctival Indentation	Baseline and 1 week.	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
Conjunctival Staining	Baseline and 1 week	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
Surface Appearance	1 week	Grade ratings category (smooth, grainy, or other)
High Contrast Acuity at High Room Illumination	Baseline and 1 week	Logarithm of the Minimum Angle or Resolution (LogMAR) Chart
Limbal Hyperemia	Baseline and 1 week	Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.