Myopia
Conditions
Brief summary
Clinical Performance of Stenfilcon vs. Filcon II 3
Detailed description
The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.
Interventions
DEVICEstenfilcon A
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
DEVICEfilcon II 3
Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must satisfy the following conditions prior to inclusion in the study: * Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older. * Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation. * Read, indicate understanding of, and sign Written Informed Consent (Appendix 1) * Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes * Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription. * An existing soft contact lens wearer of any modality. * Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so. * Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: * No amblyopia. * No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes). * No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection). * No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.) * No aphakia
Exclusion criteria
Any of the following will render a subject ineligible for inclusion: * Neophytes, who have not worn lenses before * Greater than 0.75D of refractive astigmatism in either eye * Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures. * Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear. * Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Pterygium, pinguecula or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from the limbus * Giant papillary conjunctivitis (GPC) Grade 3 or above * Anterior uveitis or iritis (past or present) * Seborrheic eczema, seborrheic conjunctivitis * History of corneal ulcer or fungal infections * Poor personal hygiene * A known history of corneal hypoesthesia (reduced corneal sensitivity). * Contact lens best corrected Snellen visual acuities (VA) worse than 6/9 * Aphakia, Keratoconus or a highly irregular cornea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wettability | 1 Week | Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds. |
| Vision Quality | Baseline | Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp) |
| Eye Whiteness | Baseline | Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white). |
| Overall Satisfaction | Baseline | Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied). |
| Visual Acuity logMAR | Baseline | Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR. |
| Daily and Comfortable Wearing Time | Baseline | Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.) |
| Handling | 1 Week | Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily). |
| Comfort | Baseline | Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all) |
| Dryness | Baseline | Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Conjunctival Redness | Baseline | Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness. |
| Corneal Staining | Baseline | Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) |
| Conjunctival Staining | 1 Week | Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe ) |
| Blood Vessel Coverage | Baseline | Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage. |
Countries
United Kingdom
Participant flow
Recruitment details
Sixty habitual contact lens wearing subjects were recruited by the Optometry Clinic at Aston University
Pre-assignment details
All subjects were habitual lens wearers and were randomized to each pair of study lenses. Only one patient failed to complete all study visits and their data was excluded from the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Stenfilcon A Then Filcon II 3 All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week. | 33 |
| Filcon II 3 Then Stenfilcon A All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week. | 26 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Filcon II 3 Then Stenfilcon A | Total | Stenfilcon A Then Filcon II 3 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 59 Participants | 33 Participants |
| Region of Enrollment United Kingdom | 26 participants | 59 participants | 33 participants |
| Sex: Female, Male Female | 18 Participants | 42 Participants | 24 Participants |
| Sex: Female, Male Male | 8 Participants | 17 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
Comfort
Participant rating for comfort. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Comfort | Insertion | 93.0 units on a scale | Standard Deviation 9.6 |
| Overall Study Group | Comfort | After 4 hours | 89.7 units on a scale | Standard Deviation 14.6 |
| Overall Study Group | Comfort | After 8 hours | 81.7 units on a scale | Standard Deviation 17.7 |
| Overall Study Group | Comfort | Removal | 75.8 units on a scale | Standard Deviation 18.8 |
| Filcon II 3 | Comfort | Removal | 72.4 units on a scale | Standard Deviation 20 |
| Filcon II 3 | Comfort | Insertion | 90.6 units on a scale | Standard Deviation 13.2 |
| Filcon II 3 | Comfort | After 8 hours | 79.0 units on a scale | Standard Deviation 17.6 |
| Filcon II 3 | Comfort | After 4 hours | 88.8 units on a scale | Standard Deviation 11.8 |
Primary
Comfort
Participant rating of lens comfort. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable,100=extreme comfort / cannot feel them at all)
Time frame: Baseline
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Comfort | On Insertion | 85.0 units on a scale | Standard Deviation 17 |
| Overall Study Group | Comfort | After 4 Hours | 91.8 units on a scale | Standard Deviation 9.1 |
| Overall Study Group | Comfort | After 8 Hours | 80.8 units on a scale | Standard Deviation 15.7 |
| Overall Study Group | Comfort | On Removal | 75.3 units on a scale | Standard Deviation 19.7 |
Primary
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses.(The hours of average comfortable wearing time and average daily wearing time.)
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Daily and Comfortable Wearing Time | Average Wearing Time | 9.8 hours | Standard Deviation 3.1 |
| Overall Study Group | Daily and Comfortable Wearing Time | Average Comfortable Wearing Time | 7.7 hours | Standard Deviation 3.4 |
Primary
Daily and Comfortable Wearing Time
Participant rating of lens Daily and Comfortable Wearing Time. Collected at 1 week wear for each lens.(The hours of average comfortable wearing time and average daily wearing time.)
Time frame: 1 week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Daily and Comfortable Wearing Time | Average Wearing Time | 11.4 hours | Standard Deviation 2.6 |
| Overall Study Group | Daily and Comfortable Wearing Time | Average Comfortable Wearing Time | 8.7 hours | Standard Deviation 3 |
| Filcon II 3 | Daily and Comfortable Wearing Time | Average Wearing Time | 10.8 hours | Standard Deviation 2.6 |
| Filcon II 3 | Daily and Comfortable Wearing Time | Average Comfortable Wearing Time | 8.7 hours | Standard Deviation 2.8 |
Primary
Dryness
Participant rating for dryness. Collected at 1 week. (0-100, 0= very uncomfortable and 100= extreme comfort/cannot feel them at all).
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Dryness | Insertion | 94.4 units on a scale | Standard Deviation 11.8 |
| Overall Study Group | Dryness | After 4 hours | 88.9 units on a scale | Standard Deviation 13.3 |
| Overall Study Group | Dryness | After 8 hours | 78.5 units on a scale | Standard Deviation 19 |
| Overall Study Group | Dryness | Removal | 72.9 units on a scale | Standard Deviation 21.1 |
| Filcon II 3 | Dryness | Removal | 70.8 units on a scale | Standard Deviation 19.1 |
| Filcon II 3 | Dryness | Insertion | 93.6 units on a scale | Standard Deviation 11.6 |
| Filcon II 3 | Dryness | After 8 hours | 79.2 units on a scale | Standard Deviation 16.7 |
| Filcon II 3 | Dryness | After 4 hours | 88.0 units on a scale | Standard Deviation 12.4 |
Primary
Dryness
Participant rating of lens dryness. Collected at baseline for habitual pair. (0-100; 0=very uncomfortable, 100=extreme comfort/ cannot feel them at all)
Time frame: Baseline
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Dryness | On Insertion | 85.6 units on a scale | Standard Deviation 26.8 |
| Overall Study Group | Dryness | After 4 Hours | 84.0 units on a scale | Standard Deviation 21.7 |
| Overall Study Group | Dryness | After 8 Hours | 73.8 units on a scale | Standard Deviation 22 |
| Overall Study Group | Dryness | On Removal | 67.1 units on a scale | Standard Deviation 25.3 |
Primary
Eye Whiteness
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Eye Whiteness | 85.3 units on a scale | Standard Deviation 12.5 |
| Filcon II 3 | Eye Whiteness | 84.9 units on a scale | Standard Deviation 13.5 |
Primary
Eye Whiteness
Participant rating for eye whiteness. Collected at baseline for habitual lenses. (0-100, 0= total redness and 100= totally white).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Eye Whiteness | 82.5 units on a scale | Standard Deviation 15 |
Primary
Handling
Participant rating for lens handling. Collected at 1 week. (Insertion: 0-100, 0= could not get it in and 100= went in without a problem. Removal: 0= could not get it out and 100= came out without a problem. Blister: 0=impossible and 100=came out extremely easily).
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Handling | From Blister | 90.8 units on a scale | Standard Deviation 11.7 |
| Overall Study Group | Handling | Inside Out | 84.9 units on a scale | Standard Deviation 24.6 |
| Overall Study Group | Handling | Insertion | 93.4 units on a scale | Standard Deviation 10.7 |
| Overall Study Group | Handling | Removal | 90.0 units on a scale | Standard Deviation 13.6 |
| Filcon II 3 | Handling | Removal | 92.0 units on a scale | Standard Deviation 11.3 |
| Filcon II 3 | Handling | From Blister | 92.2 units on a scale | Standard Deviation 0.32 |
| Filcon II 3 | Handling | Insertion | 89.3 units on a scale | Standard Deviation 13 |
| Filcon II 3 | Handling | Inside Out | 86.4 units on a scale | Standard Deviation 25.9 |
Primary
Overall Satisfaction
Participant rating for overall satisfaction. Collected at 1 week for study lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Overall Satisfaction | 85.7 units on a scale | Standard Deviation 12.4 |
| Filcon II 3 | Overall Satisfaction | 82.5 units on a scale | Standard Deviation 16.1 |
Primary
Overall Satisfaction
Participant rating for overall satisfaction. Collected at baseline for habitual lenses. (0-100, 0= extremely dissatisfied and 100= extremely satisfied).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Overall Satisfaction | 88.1 units on a scale | Standard Deviation 14 |
Primary
Vision Quality
Participant rating of vision quality. Collected at baseline for habitual lens. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Vision Quality | 92.2 units on a scale | Standard Deviation 8.6 |
Primary
Vision Quality
Participant rating of vision quality. Collected at 1 week. (0-100; 0=extremely poor vision totally blurred 100=excellent vision totally sharp)
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Vision Quality | 89.9 units on a scale | Standard Deviation 11.2 |
| Filcon II 3 | Vision Quality | 89.0 units on a scale | Standard Deviation 11.7 |
Primary
Visual Acuity logMAR
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at baseline for habitual lens. logMAR.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Visual Acuity logMAR | MHCVA OS | -0.01 logMAR | Standard Deviation 0.08 |
| Overall Study Group | Visual Acuity logMAR | BHCVA | -0.05 logMAR | Standard Deviation 0.07 |
| Overall Study Group | Visual Acuity logMAR | MHCVA OD | -0.01 logMAR | Standard Deviation 0.08 |
Primary
Visual Acuity logMAR
Assessment of Monocular (MHCVA) Right eye (OD), left eye (OS) and Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at dispense for study lenses. logMAR.
Time frame: Dispense
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Visual Acuity logMAR | MHCVA OD | -0.09 logMAR | Standard Deviation 0.1 |
| Overall Study Group | Visual Acuity logMAR | MHCVA OS | -0.09 logMAR | Standard Deviation 0.08 |
| Overall Study Group | Visual Acuity logMAR | BHCVA | -0.12 logMAR | Standard Deviation 0.08 |
| Filcon II 3 | Visual Acuity logMAR | MHCVA OD | -0.07 logMAR | Standard Deviation 0.07 |
| Filcon II 3 | Visual Acuity logMAR | MHCVA OS | -0.07 logMAR | Standard Deviation 0.06 |
| Filcon II 3 | Visual Acuity logMAR | BHCVA | -0.11 logMAR | Standard Deviation 0.07 |
Primary
Visual Acuity logMAR
Assessment of Binocular High Contrast Distance Visual Acuity (BHCVA). Collected at 1 week for study lenses. logMAR
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Visual Acuity logMAR | -0.06 logMAR | Standard Deviation 0.06 |
| Filcon II 3 | Visual Acuity logMAR | -0.03 logMAR | Standard Deviation 0.07 |
Primary
Wettability
Participant rating for surface wettability. Collected at 1 week. Tear film analysis in seconds.
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Wettability | Right Eye | 10.9 seconds | Standard Deviation 6.5 |
| Overall Study Group | Wettability | Left Eye | 11.6 seconds | Standard Deviation 9 |
| Filcon II 3 | Wettability | Right Eye | 9.2 seconds | Standard Deviation 5.4 |
| Filcon II 3 | Wettability | Left Eye | 9.6 seconds | Standard Deviation 6.1 |
Secondary
Blood Vessel Coverage
Assessment of ocular health. Collected at baseline after removal of lenses. Percent of blood vessel coverage.
Time frame: Baseline
Population: Prior to randomization
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Blood Vessel Coverage | Right Eye | 3.68 percentage of blood vessel coverage | Standard Deviation 3.05 |
| Overall Study Group | Blood Vessel Coverage | Left Eye | 3.74 percentage of blood vessel coverage | Standard Deviation 2.74 |
Secondary
Blood Vessel Coverage
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of blood vessel coverage.
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Blood Vessel Coverage | Right Eye | 4.63 percentage of blood vessel coverage | Standard Deviation 2.9 |
| Overall Study Group | Blood Vessel Coverage | Left Eye | 5.00 percentage of blood vessel coverage | Standard Deviation 3.32 |
| Filcon II 3 | Blood Vessel Coverage | Right Eye | 4.41 percentage of blood vessel coverage | Standard Deviation 2.94 |
| Filcon II 3 | Blood Vessel Coverage | Left Eye | 5.25 percentage of blood vessel coverage | Standard Deviation 4.42 |
Secondary
Conjunctival Redness
Assessment of ocular health. Collected at 1 week after removal of lenses. Percentage of conjunctival redness.
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Conjunctival Redness | Right Eye | 35.6 percentage of redness | Standard Deviation 1.4 |
| Overall Study Group | Conjunctival Redness | Left Eye | 35.8 percentage of redness | Standard Deviation 1.4 |
| Filcon II 3 | Conjunctival Redness | Right Eye | 35.4 percentage of redness | Standard Deviation 1.3 |
| Filcon II 3 | Conjunctival Redness | Left Eye | 35.4 percentage of redness | Standard Deviation 1.3 |
Secondary
Conjunctival Redness
Assessment of ocular health. Collected at baseline after removal of lenses. Percentage of conjunctival redness.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study Group | Conjunctival Redness | Right Eye | 35.1 percentage of redness | Standard Deviation 1 |
| Overall Study Group | Conjunctival Redness | Left Eye | 35.2 percentage of redness | Standard Deviation 1.2 |
Secondary
Conjunctival Staining
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Time frame: 1 Week
Population: All 59 subjects were habitual lens wearers and randomized to both sets of study lenses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Conjunctival Staining | 0.6 units on a scale | Standard Deviation 0.5 |
| Filcon II 3 | Conjunctival Staining | 0.6 units on a scale | Standard Deviation 0.4 |
Secondary
Corneal Staining
Assessment of ocular health. Collected at baseline after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Time frame: Baseline
Population: Prior to randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Corneal Staining | 0.6 units on a scale | Standard Deviation 0.6 |
Secondary
Corneal Staining
Assessment of ocular health. Collected at 1 week after removal of lenses. (Biomicroscopy, 0-4, 0=none , 4=severe )
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall Study Group | Corneal Staining | 0.4 units on a scale | Standard Deviation 0.4 |
| Filcon II 3 | Corneal Staining | 0.5 units on a scale | Standard Deviation 0.4 |