Myopia
Conditions
Brief summary
The objective of the study is to compare the overall subjective comfort profile over 8 hours of lens wear in two groups of habitual soft contact lens wearers (daily disposable hydrogel lenses and frequent replacement lenses) when refitted in to somofilcon A lenses.
Detailed description
This will be a prospective, single day, randomized, double-masked, non-dispensing, contralateral study. Participants were recruited into one of two groups - participants who habitually wore etafilcon A: daily disposable hydrogel lenses and participants who habitually wore frequent replacement lenses (FREQ).
Interventions
DEVICEetafilcon A (control)
contact lens
DEVICEsomofilcon A (test)
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A person is eligible for inclusion in the study if he/she: 1. Is at least 17 years of age and has full legal capacity to volunteer; 2. Has read and signed an information consent letter; 3. Is willing and able to follow instructions and maintain the appointment schedule; 4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction or the assigned study lenses; 5. Habitually wears either etafilcon A lens or any frequent replacement contact lenses (as defined in 4.1.1); 6. Habitually wear contact lenses with a power between -1.00 and -6.00D (Diopters) (inclusive) in both eyes; 7. Demonstrates an acceptable fit with the study lenses; 8. Is usually able to wear contact lenses for at least 8 hours per day.
Exclusion criteria
* A person will be excluded from the study if he/she: 1. Is participating in any concurrent clinical or research study; 2. Has any known active\* ocular disease and/or infection; 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. Has known sensitivity to the diagnostic substances (pharmaceuticals), such as fluorescein dye, or products to be used in the study; 6. Is aphakic; 7. Has undergone refractive error surgery. 8. Has participated in the previous somfofilcon A study (ORE# 20893) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | Baseline and 8 hours | High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart. |
| Comfort | 8 hours | Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever. |
| Comfort Preference | Baseline and 8 hours | Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens |
| Bulbar Hyperemia | Baseline and 8 hours | Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. |
| Limbal Hyperemia | Baseline and 8 hours | Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe. |
| Conjunctival Staining | 8 hours | Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central |
Countries
Canada
Participant flow
Pre-assignment details
Of the 103 enrolled, 13 participants were not eligible due to screen failure. This reporting group includes 90 participants (180 eyes) belonging to 2 groups of 45 habitual wearers of either etafilcon A lens or frequent replacement lenses (FREQ). All participants were randomized to wear etafilcon A in one eye and somofilcon A in the fellow eye.
Participants by arm
| Arm | Count |
|---|---|
| Habitual Etafilcon A Wearers Wearing Etafilcon A/Somofilcon A Habitual wearers of etafilcon A were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study. | 45 |
| Habitual FREQ Wearers Wearing Etafilcon A/Somofilcon A Habitual wearers of frequent replacement lenses (FREQ) were randomized to wear somofilcon A lens (test) and etafilcon A lens (control) in a contralateral design for 8 hours during the study. | 45 |
| Total | 90 |
Baseline characteristics
| Characteristic | Habitual Etafilcon A Wearers Wearing Etafilcon A/Somofilcon A | Habitual FREQ Wearers Wearing Etafilcon A/Somofilcon A | Total |
|---|---|---|---|
| Age, Continuous | 25 years | 25 years | 25 years |
| Sex: Female, Male Female | 35 Participants | 37 Participants | 72 Participants |
| Sex: Female, Male Male | 10 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 45 | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 | 0 / 45 | 0 / 45 |
Outcome results
Primary
Bulbar Hyperemia
Bulbar hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Time frame: Baseline and 8 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Bulbar Hyperemia | Baseline | 1.3 units on a scale | Standard Deviation 0.4 |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Bulbar Hyperemia | 8 hours | 1.3 units on a scale | Standard Deviation 0.4 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Bulbar Hyperemia | 8 hours | 1.3 units on a scale | Standard Deviation 0.4 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Bulbar Hyperemia | Baseline | 1.3 units on a scale | Standard Deviation 0.4 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Bulbar Hyperemia | Baseline | 1.2 units on a scale | Standard Deviation 0.4 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Bulbar Hyperemia | 8 hours | 1.2 units on a scale | Standard Deviation 0.4 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Bulbar Hyperemia | Baseline | 1.2 units on a scale | Standard Deviation 0.4 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Bulbar Hyperemia | 8 hours | 1.2 units on a scale | Standard Deviation 0.4 |
Primary
Comfort
Subjective ratings for lens comfort of etafilcon A and somofilcon A. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever.
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Comfort | 83 units on a scale | Standard Deviation 17 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Comfort | 77 units on a scale | Standard Deviation 22 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Comfort | 83 units on a scale | Standard Deviation 14 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Comfort | 83 units on a scale | Standard Deviation 16 |
Primary
Comfort Preference
Lens preference in regards to comfort of etafilcon A and somofilcon A. Categories: Strongly prefer etafilcon A lens, slightly prefer etafilcon A lens, no preference, slightly prefer somofilcon A lens, strongly prefer somofilcon A lens
Time frame: Baseline and 8 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Comfort Preference | Slightly Prefer Etafilcon A Lens | 14 participants |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Comfort Preference | Strongly Prefer Etafilcon A Lens | 7 participants |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Comfort Preference | Strongly Prefer Somofilcon A Lens | 2 participants |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Comfort Preference | No Preference | 12 participants |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Comfort Preference | Slightly Prefer Somofilcon A Lens | 10 participants |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Comfort Preference | No Preference | 19 participants |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Comfort Preference | Slightly Prefer Somofilcon A Lens | 11 participants |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Comfort Preference | Strongly Prefer Somofilcon A Lens | 2 participants |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Comfort Preference | Strongly Prefer Etafilcon A Lens | 3 participants |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Comfort Preference | Slightly Prefer Etafilcon A Lens | 10 participants |
| Habitual FREQ Wearers Randomized to Etafilcon A | Comfort Preference | No Preference | 5 participants |
| Habitual FREQ Wearers Randomized to Etafilcon A | Comfort Preference | Strongly Prefer Etafilcon A Lens | 13 participants |
| Habitual FREQ Wearers Randomized to Etafilcon A | Comfort Preference | Slightly Prefer Etafilcon A Lens | 11 participants |
| Habitual FREQ Wearers Randomized to Etafilcon A | Comfort Preference | Slightly Prefer Somofilcon A Lens | 9 participants |
| Habitual FREQ Wearers Randomized to Etafilcon A | Comfort Preference | Strongly Prefer Somofilcon A Lens | 7 participants |
| Habitual FREQ Wearers Randomized to Somofilcon A | Comfort Preference | Slightly Prefer Somofilcon A Lens | 8 participants |
| Habitual FREQ Wearers Randomized to Somofilcon A | Comfort Preference | Slightly Prefer Etafilcon A Lens | 16 participants |
| Habitual FREQ Wearers Randomized to Somofilcon A | Comfort Preference | Strongly Prefer Etafilcon A Lens | 2 participants |
| Habitual FREQ Wearers Randomized to Somofilcon A | Comfort Preference | No Preference | 10 participants |
| Habitual FREQ Wearers Randomized to Somofilcon A | Comfort Preference | Strongly Prefer Somofilcon A Lens | 9 participants |
Primary
Conjunctival Staining
Conjunctival staining was graded in each quadrant with scale 0-4, 0.5 steps, 0=normal, 4=severe of four areas: N - Nasal, T - Temporal, S - Superior, I - Interior, C - Central
Time frame: 8 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Conjunctival Staining | Inferior | 0.6 units on a scale | Standard Deviation 0.7 |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Conjunctival Staining | Temporal | 0.4 units on a scale | Standard Deviation 0.5 |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Conjunctival Staining | Nasal | 1.0 units on a scale | Standard Deviation 0.8 |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Conjunctival Staining | Superior | 0.3 units on a scale | Standard Deviation 0.5 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Conjunctival Staining | Superior | 0.6 units on a scale | Standard Deviation 0.8 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Conjunctival Staining | Inferior | 1.1 units on a scale | Standard Deviation 1 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Conjunctival Staining | Temporal | 1.1 units on a scale | Standard Deviation 0.9 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Conjunctival Staining | Nasal | 1.1 units on a scale | Standard Deviation 1 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Conjunctival Staining | Temporal | 0.6 units on a scale | Standard Deviation 0.6 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Conjunctival Staining | Superior | 0.2 units on a scale | Standard Deviation 0.5 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Conjunctival Staining | Nasal | 1.1 units on a scale | Standard Deviation 1 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Conjunctival Staining | Inferior | 0.6 units on a scale | Standard Deviation 0.8 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Conjunctival Staining | Inferior | 1.2 units on a scale | Standard Deviation 1.2 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Conjunctival Staining | Nasal | 1.4 units on a scale | Standard Deviation 1 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Conjunctival Staining | Temporal | 1.4 units on a scale | Standard Deviation 1 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Conjunctival Staining | Superior | 0.9 units on a scale | Standard Deviation 0.8 |
Primary
Limbal Hyperemia
Limbal hyperemia examination using Efron scale 0-4, 0.5 steps, 0=normal, 4=severe.
Time frame: Baseline and 8 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Limbal Hyperemia | Baseline | 1.2 units on a scale | Standard Deviation 0.5 |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Limbal Hyperemia | 8 hours | 1.2 units on a scale | Standard Deviation 0.4 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Limbal Hyperemia | 8 hours | 1.3 units on a scale | Standard Deviation 0.4 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Limbal Hyperemia | Baseline | 1.2 units on a scale | Standard Deviation 0.5 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Limbal Hyperemia | Baseline | 1.0 units on a scale | Standard Deviation 0.4 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Limbal Hyperemia | 8 hours | 1.4 units on a scale | Standard Deviation 0.5 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Limbal Hyperemia | Baseline | 1.0 units on a scale | Standard Deviation 0.4 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Limbal Hyperemia | 8 hours | 1.3 units on a scale | Standard Deviation 0.4 |
Primary
Visual Acuity
High contrast visual acuity at high illumination was measured with each lens at each visit using a logMAR chart.
Time frame: Baseline and 8 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Visual Acuity | Baseline | -0.05 LogMAR | Standard Deviation 0.07 |
| Habitual Etafilcon A Wearers Randomized to Etafilcon A | Visual Acuity | 8 hours | -0.06 LogMAR | Standard Deviation 0.08 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Visual Acuity | 8 hours | -0.06 LogMAR | Standard Deviation 0.1 |
| Habitual Etafilcon A Wearers Randomized to Somofilcon A | Visual Acuity | Baseline | -0.05 LogMAR | Standard Deviation 0.09 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Visual Acuity | Baseline | -0.07 LogMAR | Standard Deviation 0.06 |
| Habitual FREQ Wearers Randomized to Etafilcon A | Visual Acuity | 8 hours | -0.07 LogMAR | Standard Deviation 0.08 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Visual Acuity | Baseline | -0.06 LogMAR | Standard Deviation 0.08 |
| Habitual FREQ Wearers Randomized to Somofilcon A | Visual Acuity | 8 hours | -0.06 LogMAR | Standard Deviation 0.08 |