Myopia
Conditions
Brief summary
This purpose of this study is to compare the clinical performance and subjective acceptance of two different daily disposable limbal ring lenses.
Detailed description
This is a subject-masked, dispensing study designed to evaluate the clinical performance and subjective acceptance when comparing two different daily disposable limbal ring lenses. Limbal ring lenses, which as well as correcting vision, have a colored ring which enhance the wearer's iris and are particularly popular in East Asian countries.
Interventions
DEVICEHema-copolymer Lens
contact lens
DEVICEetafilcon A Lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects will only be eligible for the study if: * They are 18 years of age and above. * They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. * They are willing and able to follow the protocol. * They agree not to participate in other clinical research for the duration of this study. * They can attain at least 6/9 in each eye with the study lenses within the available power range. * They can be fitted with study lenses within the available power range. * The currently use soft contact lenses, or have done so within the last six months.
Exclusion criteria
Subjects will not be able to take part in the study if: * They have an ocular disorder which would normally contraindicate contact lens wear. * They have a systemic disorder which would normally contraindicate contact lens wear. * They are using any topical medication such as eye drops or ointment. * They have had cataract surgery. * They have had corneal refractive surgery. * They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * They are pregnant or lactating. * They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * They have any infectious disease which would normally contraindicate contact lens wear, or may, in the opinion of the investigator, pose a risk to study personnel; or any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reactions. * They have taken part in any other clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity - Hema-copolymer and Etafilcon A | Baseline | Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline. |
| Biomicroscopy - Hema-copolymer and Etafilcon A | 1 week | Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe). |
| Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Baseline | Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits. |
| Lens Surface - Debris - Hema-copolymer and Etafilcon A | Baseline | Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens. |
| Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Baseline | Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas. |
| Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Baseline | Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal |
| Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Baseline | Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior |
| Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Baseline | Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive |
| Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Baseline | Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive |
| Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Baseline | Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent. |
| Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Baseline | Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent. |
| Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | Baseline | Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent. |
| Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A | 1 week | Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent. |
| Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A | 1 week | Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent. |
| Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | Baseline | Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent. |
| Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | Baseline | Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent. |
Countries
United Kingdom
Participant flow
Recruitment details
Thirty subjects were dispensed lenses, and nineteen subjects successfully wore both study products.
Participants by arm
| Arm | Count |
|---|---|
| Overall Baseline Characteristics Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair
Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair
etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention (7 Days) | Discontinued | 0 | 1 |
| Second Intervention (7 Days) | Poor lens fit | 0 | 9 |
| Second Intervention (7 Days) | Poor visual acuity | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Baseline Characteristics |
|---|---|
| Age, Continuous | 29.2 years |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 | 0 / 19 |
Outcome results
Primary
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | 66.7 units on a scale | Standard Deviation 20 |
| Etafilcon A Lens | Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | 68.0 units on a scale | Standard Deviation 20.2 |
Primary
Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of attractiveness for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Time frame: Baseline
Population: 8 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | 66.9 units on a scale | Standard Deviation 16.5 |
| Etafilcon A Lens | Attractiveness (Subjective Assessment) - Hema-copolymer and Etafilcon A | 67.4 units on a scale | Standard Deviation 16.7 |
Primary
Biomicroscopy - Hema-copolymer and Etafilcon A
Biomicroscopy is analyzed for hema-copolymer and etafilcon A at 1 week. (Scale 0-4, 0=normal, 4=severe).
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Conjunctival hyperaemia | 0.96 units on a scale | Standard Deviation 0.18 |
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Corneal vascularisation | 0.10 units on a scale | Standard Deviation 0.22 |
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Corenal Staining | 0.26 units on a scale | Standard Deviation 0.41 |
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Limbal hyperameia | 0.86 units on a scale | Standard Deviation 0.27 |
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Conjunctival Staining | 0.37 units on a scale | Standard Deviation 0.28 |
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Microcysts | 0.00 units on a scale | Standard Deviation 0 |
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Papillary Conjunctivitis | 0.87 units on a scale | Standard Deviation 0.35 |
| Hema-copolymer Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Oedema | 0.00 units on a scale | Standard Deviation 0 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Papillary Conjunctivitis | 0.84 units on a scale | Standard Deviation 0.37 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Conjunctival hyperaemia | 0.96 units on a scale | Standard Deviation 0.19 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Limbal hyperameia | 0.79 units on a scale | Standard Deviation 0.25 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Corneal vascularisation | 0.11 units on a scale | Standard Deviation 0.26 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Microcysts | 0.00 units on a scale | Standard Deviation 0 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Oedema | 0.00 units on a scale | Standard Deviation 0 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Corenal Staining | 0.44 units on a scale | Standard Deviation 0.55 |
| Etafilcon A Lens | Biomicroscopy - Hema-copolymer and Etafilcon A | Conjunctival Staining | 0.33 units on a scale | Standard Deviation 0.34 |
Primary
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of comfort preference for hema-copolymer and etafilcon A assessed at baseline. Scale 0-100, 0=causes pain, 100= excellent.
Time frame: Baseline
Population: 7 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | 82.2 units on a scale | Standard Deviation 13.6 |
| Etafilcon A Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | 84.5 units on a scale | Standard Deviation 15.3 |
Primary
Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of comfort preference after insertion and before removal for hema-copolymer and etafilcon A lenses is assessed at 1 week. Scale 0-100, 0=causes pain, 100= excellent.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hema-copolymer Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Comfort after insertion | 80.8 units on a scale | Standard Deviation 17 |
| Hema-copolymer Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Comfort before removal | 69.1 units on a scale | Standard Deviation 19.2 |
| Hema-copolymer Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Overall comfort | 75.8 units on a scale | Standard Deviation 16.5 |
| Etafilcon A Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Comfort after insertion | 76.0 units on a scale | Standard Deviation 16.1 |
| Etafilcon A Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Comfort before removal | 66.6 units on a scale | Standard Deviation 19.5 |
| Etafilcon A Lens | Comfort Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Overall comfort | 69.5 units on a scale | Standard Deviation 20.8 |
Primary
Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of handling (ease of insertion and ease of removal) for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unmanageable, 100= excellent.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hema-copolymer Lens | Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A | Ease of removal | 95.2 units on a scale | Standard Deviation 8.1 |
| Hema-copolymer Lens | Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A | Ease of insertion | 92.0 units on a scale | Standard Deviation 10.3 |
| Etafilcon A Lens | Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A | Ease of insertion | 77.5 units on a scale | Standard Deviation 18.2 |
| Etafilcon A Lens | Handling (Subjective Assessment) - Hema-copolymer and Etafilcon A | Ease of removal | 90.5 units on a scale | Standard Deviation 18.3 |
Primary
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Inadequate | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Optimum | 53 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Excessive | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Excessive | 2 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Inadequate | 3 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Excessive | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Inadequate | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Inadequate | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Optimum | 40 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Excessive | 0 Eyes |
Primary
Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A
Lens fit of corneal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and lens fit of corneal centration measurements were obtained at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Inadequate | 1 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Excessive | 2 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Inadequate | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Excessive | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Optimum | 57 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Excessive | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Optimum | 46 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Extremely Inadequate | 6 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Excessive | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Corneal Centration - Hema-copolymer and Etafilcon A | Slightly Inadequate | 8 Eyes |
Primary
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Nasal | 2 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Temporal | 45 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Nasal | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Temporal | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Optimum | 11 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Temporal | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Optimum | 13 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Nasal | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Temporal | 27 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Nasal | 0 Eyes |
Primary
Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A
Lens fit of horizontal centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and lens fit of horizontal centration measurements were obtained at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Nasal | 1 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Temporal | 38 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Optimum | 21 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Temporal | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Nasal | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Temporal | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Extremely Nasal | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Nasal | 1 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Optimum | 19 Eyes |
| Etafilcon A Lens | Lens Fit - Horizontal Centration - Hema-copolymer and Etafilcon A | Slightly Temporal | 40 Eyes |
Primary
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Excessive | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Inadequate | 5 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Optimum | 33 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Excessive | 20 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Inadequate | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Excessive | 8 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Excessive | 2 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Inadequate | 2 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Inadequate | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Optimum | 28 Eyes |
Primary
Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A
Lens fit of lens movement for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and lens movement measurements were obtained at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Excessive | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Inadequate | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Inadequate | 7 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Optimum | 41 Eyes |
| Hema-copolymer Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Excessive | 12 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Excessive | 16 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Optimum | 35 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Inadequate | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Extremely Excessive | 9 Eyes |
| Etafilcon A Lens | Lens Fit - Lens Movement - Hema-copolymer and Etafilcon A | Slightly Inadequate | 0 Eyes |
Primary
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at 1 week. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Inferior | 35 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Superior | 7 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Optimum | 16 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Superior | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Inferior | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Superior | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Inferior | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Inferior | 11 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Optimum | 17 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Superior | 12 Eyes |
Primary
Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A
Lens fit of vertical centration for hema-copolymer and etafilcon A lenses assessed at baseline. Overall score measured by extremely inferior, slightly inferior, optimum, slightly superior, extremely superior
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and lens fit of vertical centration measurements were obtained at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Inferior | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Superior | 10 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Optimum | 28 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Superior | 0 Eyes |
| Hema-copolymer Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Inferior | 22 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Superior | 0 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Extremely Inferior | 2 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Inferior | 24 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Optimum | 19 Eyes |
| Etafilcon A Lens | Lens Fit - Vertical Centration - Hema-copolymer and Etafilcon A | Slightly Superior | 15 Eyes |
Primary
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 1 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 2 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 0 | 29 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 0 | 18 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 1 | 2 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 2 | 0 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
Primary
Lens Surface - Debris - Hema-copolymer and Etafilcon A
Lens surface of debris for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=no debris present, 4=debris present more than two thirds of area beneath lens.
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and lens surface of debris measurements were obtained at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 1 | 1 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 2 | 1 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 0 | 28 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 0 | 27 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 1 | 3 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 2 | 0 participants |
| Etafilcon A Lens | Lens Surface - Debris - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
Primary
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and lens surface of deposition measurements were obtained at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 1 | 1 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 0 | 29 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 2 | 0 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 2 | 0 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 0 | 30 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 1 | 0 participants |
Primary
Lens Surface - Deposition - Hema-copolymer and Etafilcon A
Lens surface of deposition for hema-copolymer and etafilcon A pair of lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=absent, clean surface, 4= multiple deposits.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 1 | 3 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 2 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 0 | 26 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 0 | 14 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 1 | 6 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 2 | 0 participants |
| Etafilcon A Lens | Lens Surface - Deposition - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
Primary
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Lens surface of wettability for hema-copolymer and etafilcon A pair lenses assessed at 1 week. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 1 | 6 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 2 | 4 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 0 | 19 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 0 | 13 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 1 | 6 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 2 | 1 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
Primary
Lens Surface - Wettability - Hema-copolymer and Etafilcon A
Lens surface of wettability for hema-copolymer and etafilcon A pair of lenses assessed at baseline. (Each pair of lenses worn by the participant was assigned a single grade). Overall score measured by Grade 0-4; 0=fully wetting lens surface, 4=presence of one or more non-wetting areas.
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and lens surface of wettability measurements were obtained at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 1 | 2 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 2 | 1 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Hema-copolymer Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 0 | 27 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 4 | 0 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 0 | 25 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 1 | 4 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 2 | 1 participants |
| Etafilcon A Lens | Lens Surface - Wettability - Hema-copolymer and Etafilcon A | Grade 3 | 0 participants |
Primary
Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of ocular redness for hema-copolymer and etafilcon A lenses lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A | 87.2 units on a scale | Standard Deviation 15.7 |
| Etafilcon A Lens | Ocular Redness (Subjective Assessment) - Hema-copolymer and Etafilcon A | 89.0 units on a scale | Standard Deviation 9 |
Primary
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=extremely poor, 100= excellent.
Time frame: 1 week
Population: 11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | 75.0 units on a scale | Standard Deviation 15.2 |
| Etafilcon A Lens | Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | 63.9 units on a scale | Standard Deviation 21.5 |
Primary
Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective assessment of the overall impression for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=extremely poor, 100= excellent.
Time frame: Baseline
Population: 8 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | 81.3 units on a scale | Standard Deviation 14.6 |
| Etafilcon A Lens | Overall Impression (Subjective Assessment) - Hema-copolymer and Etafilcon A | 78.9 units on a scale | Standard Deviation 14.5 |
Primary
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of peripheral blur is assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Time frame: Baseline
Population: 8 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | 85.1 units on a scale | Standard Deviation 14.7 |
| Etafilcon A Lens | Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | 87.6 units on a scale | Standard Deviation 14.9 |
Primary
Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of peripheral blur assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | 80.2 units on a scale | Standard Deviation 16.4 |
| Etafilcon A Lens | Peripheral Blur (Subjective Assessment) - Hema-copolymer and Etafilcon A | 76.4 units on a scale | Standard Deviation 17.3 |
Primary
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at 1 week. Scale 0-100, 0=unacceptable, 100= excellent.
Time frame: 1 week
Population: 11 subjects discontinued the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hema-copolymer Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Distance vision | 85.6 units on a scale | Standard Deviation 11.3 |
| Hema-copolymer Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Vision at night | 83.3 units on a scale | Standard Deviation 14 |
| Hema-copolymer Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Variable vision | 83.1 units on a scale | Standard Deviation 17.4 |
| Etafilcon A Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Distance vision | 71.6 units on a scale | Standard Deviation 22.7 |
| Etafilcon A Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Vision at night | 65.0 units on a scale | Standard Deviation 21.3 |
| Etafilcon A Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | Variable vision | 67.4 units on a scale | Standard Deviation 22.7 |
Primary
Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A
Subjective Assessment of vision preference for hema-copolymer and etafilcon A lenses assessed at baseline. Scale 0-100, 0=unacceptable, 100= excellent.
Time frame: Baseline
Population: 8 subjects discontinued the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hema-copolymer Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | 87.6 units on a scale | Standard Deviation 11.5 |
| Etafilcon A Lens | Vision Preference (Subjective Assessment) - Hema-copolymer and Etafilcon A | 84.4 units on a scale | Standard Deviation 12.3 |
Primary
Visual Acuity - Hema-copolymer and Etafilcon A
Visual acuity measured by logMAR for hema-copolymer and etafilcon A lenses assessed at 1 week.
Time frame: 1 week
Population: 11 subjects discontinued the study. Missing data of 1 subject for hema-copolymer group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hema-copolymer Lens | Visual Acuity - Hema-copolymer and Etafilcon A | High Contrast | -0.08 logMAR | Standard Deviation 0.1 |
| Hema-copolymer Lens | Visual Acuity - Hema-copolymer and Etafilcon A | Low Contrast | 0.18 logMAR | Standard Deviation 0.09 |
| Etafilcon A Lens | Visual Acuity - Hema-copolymer and Etafilcon A | High Contrast | -0.04 logMAR | Standard Deviation 0.1 |
| Etafilcon A Lens | Visual Acuity - Hema-copolymer and Etafilcon A | Low Contrast | 0.23 logMAR | Standard Deviation 0.1 |
Primary
Visual Acuity - Hema-copolymer and Etafilcon A
Visual acuity measured by logMAR of hema-copolymer and etafilcon A lenses assessed at baseline.
Time frame: Baseline
Population: All 30 subjects were dispensed lenses, and visual acuity measurements were obtained at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hema-copolymer Lens | Visual Acuity - Hema-copolymer and Etafilcon A | High Contrast | -0.08 logMAR | Standard Deviation 0.09 |
| Hema-copolymer Lens | Visual Acuity - Hema-copolymer and Etafilcon A | Low Contrast | 0.17 logMAR | Standard Deviation 0.1 |
| Etafilcon A Lens | Visual Acuity - Hema-copolymer and Etafilcon A | High Contrast | -0.04 logMAR | Standard Deviation 0.09 |
| Etafilcon A Lens | Visual Acuity - Hema-copolymer and Etafilcon A | Low Contrast | 0.20 logMAR | Standard Deviation 0.14 |