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

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

Detailed Description
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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).

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

Conditions
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Myopia

Intervention / Treatment
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* Device: silicone hydrogel lens (test)
* Device: enfilcon A lens (control)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |