Myopia
Conditions
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).
Interventions
DEVICEsilicone hydrogel lens (test)
contact lens
DEVICEenfilcon A lens (control)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| High Contrast Acuity at High Room Illumination | Baseline and 1 week | Logarithm of the Minimum Angle or Resolution (LogMAR) Chart |
| Lens Deposition | Baseline and 1 week | Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced |
| Lens Problems | Baseline and 1 week | Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings. |
| Lens Centration | Baseline | 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 |
| 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) |
| 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. |
| 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. |
| 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 |
| Lens Wettability | Baseline and 1 week | Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced. |
| 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) |
| Bulbar Hyperemia | Baseline and 1 week | Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia. |
| Limbal Hyperemia | Baseline and 1 week | Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia. |
| Corneal Dehydration Staining | 1 week | Corneal Staining: Dehydration Staining: Yes/No |
| 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 |
| 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. |
| Surface Appearance | Baseline | Grade ratings category (smooth, grainy, or other) |
Countries
Canada
Participant flow
Pre-assignment details
One participant discontinued from the study as a screen failure before lens randomization.
Participants by arm
| Arm | Count |
|---|---|
| Overall Baseline Characteristics Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Overall Baseline Characteristics |
|---|---|
| Age, Continuous | 24 years |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Comfort | Lens dispense at baseline | 90 units on a scale | Standard Deviation 11 |
| Silicone Hydrogel Lens (Test) | Comfort | Lens insertion at 1 week | 92 units on a scale | Standard Deviation 9 |
| Silicone Hydrogel Lens (Test) | Comfort | Overall comfort at 1 week | 79 units on a scale | Standard Deviation 15 |
| Enfilcon A Lens (Control) | Comfort | Lens dispense at baseline | 91 units on a scale | Standard Deviation 10 |
| Enfilcon A Lens (Control) | Comfort | Lens insertion at 1 week | 90 units on a scale | Standard Deviation 14 |
| Enfilcon A Lens (Control) | Comfort | Overall comfort at 1 week | 81 units on a scale | Standard Deviation 13 |
Primary
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.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Dryness | Lens dispense at baseline | 94 units on a scale | Standard Deviation 10 |
| Silicone Hydrogel Lens (Test) | Dryness | Lens insertion at 1 week | 94 units on a scale | Standard Deviation 8 |
| Silicone Hydrogel Lens (Test) | Dryness | Overall dryness at 1 week | 75 units on a scale | Standard Deviation 19 |
| Enfilcon A Lens (Control) | Dryness | Lens dispense at baseline | 94 units on a scale | Standard Deviation 10 |
| Enfilcon A Lens (Control) | Dryness | Lens insertion at 1 week | 92 units on a scale | Standard Deviation 12 |
| Enfilcon A Lens (Control) | Dryness | Overall dryness at 1 week | 78 units on a scale | Standard Deviation 16 |
Secondary
Bulbar Hyperemia
Bulbar hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Bulbar Hyperemia | Baseline | 1.96 units on a scale | Standard Deviation 0.5 |
| Silicone Hydrogel Lens (Test) | Bulbar Hyperemia | 1 week | 1.87 units on a scale | Standard Deviation 0.44 |
| Enfilcon A Lens (Control) | Bulbar Hyperemia | Baseline | 1.96 units on a scale | Standard Deviation 0.5 |
| Enfilcon A Lens (Control) | Bulbar Hyperemia | 1 week | 1.95 units on a scale | Standard Deviation 0.41 |
Secondary
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
Time frame: Baseline and 1 week.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Nasal - baseline | 0.01 units on a scale | Standard Deviation 0.11 |
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Nasal - 1 week | 0.36 units on a scale | Standard Deviation 0.64 |
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Temporal - baseline | 0.00 units on a scale | Standard Deviation 0 |
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Temporal - 1 week | 0.39 units on a scale | Standard Deviation 0.68 |
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Superior - baseline | 0.00 units on a scale | Standard Deviation 0 |
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Superior - 1 week | 0.21 units on a scale | Standard Deviation 0.49 |
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Inferior - baseline | 0.00 units on a scale | Standard Deviation 0 |
| Silicone Hydrogel Lens (Test) | Conjunctival Indentation | Inferior - 1 week | 0.34 units on a scale | Standard Deviation 0.67 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Inferior - 1 week | 0.03 units on a scale | Standard Deviation 0.15 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Nasal - baseline | 0.01 units on a scale | Standard Deviation 0.11 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Superior - baseline | 0.00 units on a scale | Standard Deviation 0 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Nasal - 1 week | 0.01 units on a scale | Standard Deviation 0.06 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Inferior - baseline | 0.00 units on a scale | Standard Deviation 0 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Temporal - baseline | 0.00 units on a scale | Standard Deviation 0 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Superior - 1 week | 0.02 units on a scale | Standard Deviation 0.1 |
| Enfilcon A Lens (Control) | Conjunctival Indentation | Temporal - 1 week | 0.02 units on a scale | Standard Deviation 0.1 |
Secondary
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
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Temporal - baseline | 0.47 units on a scale | Standard Deviation 0.49 |
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Inferior - baseline | 0.23 units on a scale | Standard Deviation 0.38 |
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Nasal - baseline | 0.48 units on a scale | Standard Deviation 0.45 |
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Nasal - 1 week | 0.67 units on a scale | Standard Deviation 0.58 |
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Temporal - 1 week | 0.72 units on a scale | Standard Deviation 0.63 |
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Superior - baseline | 0.12 units on a scale | Standard Deviation 0.29 |
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Superior - 1 week | 0.25 units on a scale | Standard Deviation 0.38 |
| Silicone Hydrogel Lens (Test) | Conjunctival Staining | Inferior - 1 week | 0.49 units on a scale | Standard Deviation 0.52 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Inferior - 1 week | 0.32 units on a scale | Standard Deviation 0.37 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Temporal - baseline | 0.47 units on a scale | Standard Deviation 0.49 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Temporal - 1 week | 0.55 units on a scale | Standard Deviation 0.43 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Inferior - baseline | 0.23 units on a scale | Standard Deviation 0.38 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Superior - 1 week | 0.14 units on a scale | Standard Deviation 0.26 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Nasal - baseline | 0.48 units on a scale | Standard Deviation 0.45 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Superior - baseline | 0.12 units on a scale | Standard Deviation 0.29 |
| Enfilcon A Lens (Control) | Conjunctival Staining | Nasal - 1 week | 0.46 units on a scale | Standard Deviation 0.4 |
Secondary
Corneal Dehydration Staining
Corneal Staining: Dehydration Staining: Yes/No
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Corneal Dehydration Staining | Both eyes | 3 participants |
| Silicone Hydrogel Lens (Test) | Corneal Dehydration Staining | One eye | 2 participants |
| Enfilcon A Lens (Control) | Corneal Dehydration Staining | One eye | 2 participants |
| Enfilcon A Lens (Control) | Corneal Dehydration Staining | Both eyes | 1 participants |
Secondary
Corneal Staining (Extent)
Corneal staining extent, grade as % of each zone: C - Central, N - Nasal, T - Temporal, S - Superior, I - Interior
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Nasal - baseline | 4.76 percentage of cornea | Standard Deviation 9.1 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Central - 1 week | 0.64 percentage of cornea | Standard Deviation 1.73 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Superior - baseline | 2.15 percentage of cornea | Standard Deviation 7.21 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Nasal - 1 week | 2.20 percentage of cornea | Standard Deviation 6.68 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Superior - 1 week | 1.75 percentage of cornea | Standard Deviation 4.42 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Central - baseline | 1.21 percentage of cornea | Standard Deviation 4.97 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Inferior - baseline | 5.88 percentage of cornea | Standard Deviation 10.85 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Temporal - baseline | 2.04 percentage of cornea | Standard Deviation 5.47 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Inferior - 1 week | 6.48 percentage of cornea | Standard Deviation 11.52 |
| Silicone Hydrogel Lens (Test) | Corneal Staining (Extent) | Temporal - 1 week | 1.38 percentage of cornea | Standard Deviation 4.05 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Inferior - 1 week | 5.01 percentage of cornea | Standard Deviation 9.23 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Central - baseline | 1.21 percentage of cornea | Standard Deviation 4.97 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Central - 1 week | 0.75 percentage of cornea | Standard Deviation 4.97 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Nasal - baseline | 4.76 percentage of cornea | Standard Deviation 9.1 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Nasal - 1 week | 1.43 percentage of cornea | Standard Deviation 4.79 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Temporal - baseline | 2.04 percentage of cornea | Standard Deviation 5.47 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Temporal - 1 week | 1.04 percentage of cornea | Standard Deviation 2.92 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Superior - baseline | 2.15 percentage of cornea | Standard Deviation 7.21 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Superior - 1 week | 0.69 percentage of cornea | Standard Deviation 2.07 |
| Enfilcon A Lens (Control) | Corneal Staining (Extent) | Inferior - baseline | 5.88 percentage of cornea | Standard Deviation 10.85 |
Secondary
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
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Ease of Lens Insertion | Baseline | 97 units on a scale | Standard Deviation 5 |
| Silicone Hydrogel Lens (Test) | Ease of Lens Insertion | 1 week | 91 units on a scale | Standard Deviation 9 |
| Enfilcon A Lens (Control) | Ease of Lens Insertion | Baseline | 92 units on a scale | Standard Deviation 10 |
| Enfilcon A Lens (Control) | Ease of Lens Insertion | 1 week | 90 units on a scale | Standard Deviation 10 |
Secondary
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Ease of Lens Removal | 86 units on a scale | Standard Deviation 15 |
| Enfilcon A Lens (Control) | Ease of Lens Removal | 90 units on a scale | Standard Deviation 12 |
Secondary
High Contrast Acuity at High Room Illumination
Logarithm of the Minimum Angle or Resolution (LogMAR) Chart
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | High Contrast Acuity at High Room Illumination | Baseline | -0.10 LogMAR | Standard Deviation 0.06 |
| Silicone Hydrogel Lens (Test) | High Contrast Acuity at High Room Illumination | 1 week | -0.10 LogMAR | Standard Deviation 0.05 |
| Enfilcon A Lens (Control) | High Contrast Acuity at High Room Illumination | Baseline | -0.09 LogMAR | Standard Deviation 0.04 |
| Enfilcon A Lens (Control) | High Contrast Acuity at High Room Illumination | 1 week | -0.08 LogMAR | Standard Deviation 0.06 |
Secondary
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
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Lens Centration | S | 8 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | N | 1 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | I | 10 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | No decentration | 43 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | N/S | 1 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | T/S | 3 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | T | 12 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | T/I | 1 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | N/I | 1 eyes |
| Enfilcon A Lens (Control) | Lens Centration | T/I | 7 eyes |
| Enfilcon A Lens (Control) | Lens Centration | N/I | 0 eyes |
| Enfilcon A Lens (Control) | Lens Centration | No decentration | 51 eyes |
| Enfilcon A Lens (Control) | Lens Centration | N | 1 eyes |
| Enfilcon A Lens (Control) | Lens Centration | T | 6 eyes |
| Enfilcon A Lens (Control) | Lens Centration | S | 4 eyes |
| Enfilcon A Lens (Control) | Lens Centration | I | 9 eyes |
| Enfilcon A Lens (Control) | Lens Centration | T/S | 2 eyes |
| Enfilcon A Lens (Control) | Lens Centration | N/S | 0 eyes |
Secondary
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
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Lens Centration | N | 4 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | N/S | 0 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | S | 6 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | N/I | 0 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | T | 16 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | T/S | 2 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | I | 4 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | T/I | 2 eyes |
| Silicone Hydrogel Lens (Test) | Lens Centration | No decentration | 46 eyes |
| Enfilcon A Lens (Control) | Lens Centration | T/I | 4 eyes |
| Enfilcon A Lens (Control) | Lens Centration | No decentration | 32 eyes |
| Enfilcon A Lens (Control) | Lens Centration | N | 3 eyes |
| Enfilcon A Lens (Control) | Lens Centration | T | 16 eyes |
| Enfilcon A Lens (Control) | Lens Centration | S | 6 eyes |
| Enfilcon A Lens (Control) | Lens Centration | I | 11 eyes |
| Enfilcon A Lens (Control) | Lens Centration | N/S | 0 eyes |
| Enfilcon A Lens (Control) | Lens Centration | N/I | 2 eyes |
| Enfilcon A Lens (Control) | Lens Centration | T/S | 6 eyes |
Secondary
Lens Deposition
Lens Deposits Scale 0-4, 0.25 steps. 0=excellent; 4=severely reduced
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Lens Deposition | Baseline | 0.06 units on a scale | Standard Deviation 0.13 |
| Silicone Hydrogel Lens (Test) | Lens Deposition | 1 week | 0.28 units on a scale | Standard Deviation 0.32 |
| Enfilcon A Lens (Control) | Lens Deposition | Baseline | 0.12 units on a scale | Standard Deviation 0.21 |
| Enfilcon A Lens (Control) | Lens Deposition | 1 week | 0.38 units on a scale | Standard Deviation 0.48 |
Secondary
Lens Problems
Lenses were evaluated for defects, scratches, fibers, blue specks, and other findings.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Lens Problems | Baseline, Blue specs | 0 Lenses |
| Silicone Hydrogel Lens (Test) | Lens Problems | Baseline, Fibers | 0 Lenses |
| Silicone Hydrogel Lens (Test) | Lens Problems | Baseline, Nick | 0 Lenses |
| Silicone Hydrogel Lens (Test) | Lens Problems | 1 week, Blue specs | 0 Lenses |
| Silicone Hydrogel Lens (Test) | Lens Problems | 1 week, Nick | 0 Lenses |
| Silicone Hydrogel Lens (Test) | Lens Problems | 1 week, Particles | 0 Lenses |
| Enfilcon A Lens (Control) | Lens Problems | 1 week, Nick | 1 Lenses |
| Enfilcon A Lens (Control) | Lens Problems | Baseline, Blue specs | 2 Lenses |
| Enfilcon A Lens (Control) | Lens Problems | 1 week, Blue specs | 2 Lenses |
| Enfilcon A Lens (Control) | Lens Problems | Baseline, Fibers | 1 Lenses |
| Enfilcon A Lens (Control) | Lens Problems | 1 week, Particles | 3 Lenses |
| Enfilcon A Lens (Control) | Lens Problems | Baseline, Nick | 1 Lenses |
Secondary
Lens Tightness
Lens tightness Scale 0%-100%, 0%=extremely loose fit, 50%=optimal push resistance and smooth return, 100%=no movement.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Lens Tightness | Baseline | 50.9 percentage of tightness | Standard Deviation 7.8 |
| Silicone Hydrogel Lens (Test) | Lens Tightness | 1 week | 48.8 percentage of tightness | Standard Deviation 9.1 |
| Enfilcon A Lens (Control) | Lens Tightness | Baseline | 48.1 percentage of tightness | Standard Deviation 6.3 |
| Enfilcon A Lens (Control) | Lens Tightness | 1 week | 47.9 percentage of tightness | Standard Deviation 6.4 |
Secondary
Lens Wettability
Grading scale 0-4, 0.25 steps, 0=excellent; 4=severely reduced.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Lens Wettability | Baseline | 1.09 units on a scale | Standard Deviation 0.6 |
| Silicone Hydrogel Lens (Test) | Lens Wettability | 1 week | 1.17 units on a scale | Standard Deviation 0.76 |
| Enfilcon A Lens (Control) | Lens Wettability | Baseline | 1.18 units on a scale | Standard Deviation 0.87 |
| Enfilcon A Lens (Control) | Lens Wettability | 1 week | 1.38 units on a scale | Standard Deviation 0.79 |
Secondary
Limbal Hyperemia
Limbal hyperemia assessed using scale 0-4, 0.5 steps, 0=No hyperemia, 4=Severe hyperemia.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Limbal Hyperemia | Baseline | 1.76 units on a scale | Standard Deviation 0.51 |
| Silicone Hydrogel Lens (Test) | Limbal Hyperemia | 1 week | 1.68 units on a scale | Standard Deviation 0.42 |
| Enfilcon A Lens (Control) | Limbal Hyperemia | Baseline | 1.76 units on a scale | Standard Deviation 0.51 |
| Enfilcon A Lens (Control) | Limbal Hyperemia | 1 week | 1.71 units on a scale | Standard Deviation 0.37 |
Secondary
Overall Lens Fit
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Overall Lens Fit | Baseline | 3.35 units on a scale | Standard Deviation 0.42 |
| Silicone Hydrogel Lens (Test) | Overall Lens Fit | 1 week | 3.36 units on a scale | Standard Deviation 0.41 |
| Enfilcon A Lens (Control) | Overall Lens Fit | Baseline | 3.33 units on a scale | Standard Deviation 0.36 |
| Enfilcon A Lens (Control) | Overall Lens Fit | 1 week | 3.38 units on a scale | Standard Deviation 0.48 |
Secondary
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Post-blink Movement | Baseline | 0.26 mm steps | Standard Deviation 0.16 |
| Silicone Hydrogel Lens (Test) | Post-blink Movement | 1 week | 0.24 mm steps | Standard Deviation 0.1 |
| Enfilcon A Lens (Control) | Post-blink Movement | Baseline | 0.25 mm steps | Standard Deviation 0.1 |
| Enfilcon A Lens (Control) | Post-blink Movement | 1 week | 0.27 mm steps | Standard Deviation 0.13 |
Secondary
Surface Appearance
Grade ratings category (smooth, grainy, or other)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Surface Appearance | Smooth | 77 Eyes |
| Silicone Hydrogel Lens (Test) | Surface Appearance | Grainy | 1 Eyes |
| Silicone Hydrogel Lens (Test) | Surface Appearance | Other | 2 Eyes |
| Enfilcon A Lens (Control) | Surface Appearance | Smooth | 72 Eyes |
| Enfilcon A Lens (Control) | Surface Appearance | Grainy | 4 Eyes |
| Enfilcon A Lens (Control) | Surface Appearance | Other | 4 Eyes |
Secondary
Surface Appearance
Grade ratings category (smooth, grainy, or other)
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Surface Appearance | Smooth | 76 Eyes |
| Silicone Hydrogel Lens (Test) | Surface Appearance | Grainy | 3 Eyes |
| Silicone Hydrogel Lens (Test) | Surface Appearance | Other | 1 Eyes |
| Enfilcon A Lens (Control) | Surface Appearance | Smooth | 70 Eyes |
| Enfilcon A Lens (Control) | Surface Appearance | Grainy | 4 Eyes |
| Enfilcon A Lens (Control) | Surface Appearance | Other | 6 Eyes |
Secondary
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.
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Silicone Hydrogel Lens (Test) | Visual Quality | Lens dispense at baseline | 94 units on a scale | Standard Deviation 7 |
| Silicone Hydrogel Lens (Test) | Visual Quality | Lens insertion at 1 week | 95 units on a scale | Standard Deviation 7 |
| Silicone Hydrogel Lens (Test) | Visual Quality | Overall vision quality at 1 week | 88 units on a scale | Standard Deviation 12 |
| Enfilcon A Lens (Control) | Visual Quality | Lens dispense at baseline | 93 units on a scale | Standard Deviation 9 |
| Enfilcon A Lens (Control) | Visual Quality | Lens insertion at 1 week | 94 units on a scale | Standard Deviation 9 |
| Enfilcon A Lens (Control) | Visual Quality | Overall vision quality at 1 week | 88 units on a scale | Standard Deviation 13 |