Myopia
Conditions
Brief summary
The aim of this dispensing study is to evaluate the clinical performance of existing wearers of Avaira sphere lenses following a refit with Clariti Elite sphere over 4 weeks of daily wear.
Detailed description
This is a 30-subject, prospective dispensing study comparing the clinical performance of the subjects' habitual Avaira sphere lenses following a refit with Clariti Elite sphere lenses. Subject's habitual Avaira sphere lenses will be evaluated at the first visit and then re-fitted with a pair of Clariti Elite sphere lenses for 4 weeks of daily wear. After the dispensing visit, subjects will return for evaluations at 1 week, 2 weeks and 4 weeks.
Interventions
DEVICEsomofilcon A
somofilcon A lens
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Is between 18 and 40 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted Avaira sphere contact lens (CL) wearer (at least 1 week in Avaira sphere) * Has a contact lens spherical prescription between -1.00 to - 6.00 (inclusive) * Has a spectacle cylinder up to 0.75D in each eye. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter. * Patient contact lens refraction should fit within the available parameters of the study lenses. * Is willing to comply with the wear schedule (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule
Exclusion criteria
* Is not a habitual wearer of Avaira sphere lenses * Has a contact lens prescription outside the range of the available parameters of the study lenses. * Has a spectacle cylinder ≥1.00D of cylinder in either eye. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. * Presence of clinically significant (grade 2-4) anterior segment abnormalities * Presence of ocular or systemic disease or need of medications 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 of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (past or present) * Seborrheic eczema, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has Presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity - Enfilcon A and Somofilcon A | Baseline, 1 Week, 2 Week, 4 Week | Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. |
| Subjective Assessments. - Enfilcon A and Somofilcon A | Baseline, 1 Week, 2 Week, 4 Week | Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Enfilcon A / Somofilcon A All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens
somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Enfilcon A / Somofilcon A |
|---|---|
| Age, Continuous | 22.10 years STANDARD_DEVIATION 2.02 |
| Region of Enrollment Spain | 30 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Subjective Assessments. - Enfilcon A and Somofilcon A
Subjective assessments for: comfort, dryness, handling, overall vision satisfaction, and eye whiteness. Enfilcon A was assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week. Scale(s): comfort (0=very poor; 10=excellent), dryness (0=very dry; 10=no dryness), handling (0=very difficult; 10=very easy), overall vision satisfaction (0=very unsatisfied; 10=very satisfied), habitual eye whiteness (0=not white; 10= totally white)
Time frame: Baseline, 1 Week, 2 Week, 4 Week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness during the day | 8.33 units on a scale | Standard Deviation 0.84 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall comfort | 8.47 units on a scale | Standard Deviation 0.82 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall vision satifaction | 8.47 units on a scale | Standard Deviation 0.78 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Handling | 8.50 units on a scale | Standard Deviation 0.68 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall dryness | 8.40 units on a scale | Standard Deviation 0.89 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness prior to removal | 8.47 units on a scale | Standard Deviation 0.86 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort on insertion | 8.43 units on a scale | Standard Deviation 0.77 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort prior to removal | 8.53 units on a scale | Standard Deviation 0.73 |
| Enfilcon A | Subjective Assessments. - Enfilcon A and Somofilcon A | Habitual eye whiteness | 8.40 units on a scale | Standard Deviation 0.81 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort on insertion | 7.73 units on a scale | Standard Deviation 0.83 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort prior to removal | 7.20 units on a scale | Standard Deviation 1.16 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall comfort | 7.40 units on a scale | Standard Deviation 0.97 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness during the day | 8.17 units on a scale | Standard Deviation 0.95 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness prior to removal | 7.77 units on a scale | Standard Deviation 1.04 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall dryness | 7.43 units on a scale | Standard Deviation 1.07 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Handling | 7.70 units on a scale | Standard Deviation 1.15 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall vision satifaction | 8.37 units on a scale | Standard Deviation 0.81 |
| Somofilcon A at 1 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Habitual eye whiteness | 8.23 units on a scale | Standard Deviation 0.73 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall vision satifaction | 8.10 units on a scale | Standard Deviation 0.92 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness prior to removal | 7.27 units on a scale | Standard Deviation 1.05 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort on insertion | 7.33 units on a scale | Standard Deviation 0.76 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall dryness | 7.13 units on a scale | Standard Deviation 0.97 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall comfort | 7.07 units on a scale | Standard Deviation 0.98 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Handling | 7.07 units on a scale | Standard Deviation 0.94 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort prior to removal | 6.90 units on a scale | Standard Deviation 1.03 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Habitual eye whiteness | 8.17 units on a scale | Standard Deviation 0.87 |
| Somofilcon A at 2 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness during the day | 7.63 units on a scale | Standard Deviation 1.07 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness during the day | 6.97 units on a scale | Standard Deviation 1.07 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall vision satifaction | 7.53 units on a scale | Standard Deviation 0.78 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Handling | 6.40 units on a scale | Standard Deviation 0.93 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Dryness prior to removal | 6.80 units on a scale | Standard Deviation 1.16 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort prior to removal | 6.50 units on a scale | Standard Deviation 0.94 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Comfort on insertion | 6.80 units on a scale | Standard Deviation 0.81 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall dryness | 6.77 units on a scale | Standard Deviation 1.14 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Overall comfort | 6.60 units on a scale | Standard Deviation 0.93 |
| Somofilcon A at 4 Week | Subjective Assessments. - Enfilcon A and Somofilcon A | Habitual eye whiteness | 7.73 units on a scale | Standard Deviation 0.83 |
Primary
Visual Acuity - Enfilcon A and Somofilcon A
Monocular and binocular logMAR visual acuity for enfilcon A / somofilcon A assessed at baseline and somofilcon A lenses assessed at 1 week, 2 week, 4 week.
Time frame: Baseline, 1 Week, 2 Week, 4 Week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Enfilcon A | Visual Acuity - Enfilcon A and Somofilcon A | OD | -0.037 logMar | Standard Deviation 0.049 |
| Enfilcon A | Visual Acuity - Enfilcon A and Somofilcon A | Binocular | -0.067 logMar | Standard Deviation 0.066 |
| Enfilcon A | Visual Acuity - Enfilcon A and Somofilcon A | OS | -0.037 logMar | Standard Deviation 0.049 |
| Somofilcon A at 1 Week | Visual Acuity - Enfilcon A and Somofilcon A | OD | -0.037 logMar | Standard Deviation 0.049 |
| Somofilcon A at 1 Week | Visual Acuity - Enfilcon A and Somofilcon A | Binocular | -0.067 logMar | Standard Deviation 0.066 |
| Somofilcon A at 1 Week | Visual Acuity - Enfilcon A and Somofilcon A | OS | -0.037 logMar | Standard Deviation 0.049 |
| Somofilcon A at 2 Week | Visual Acuity - Enfilcon A and Somofilcon A | OS | -0.037 logMar | Standard Deviation 0.049 |
| Somofilcon A at 2 Week | Visual Acuity - Enfilcon A and Somofilcon A | OD | -0.037 logMar | Standard Deviation 0.049 |
| Somofilcon A at 2 Week | Visual Acuity - Enfilcon A and Somofilcon A | Binocular | -0.067 logMar | Standard Deviation 0.066 |
| Somofilcon A at 4 Week | Visual Acuity - Enfilcon A and Somofilcon A | OD | -0.037 logMar | Standard Deviation 0.049 |
| Somofilcon A at 4 Week | Visual Acuity - Enfilcon A and Somofilcon A | Binocular | -0.067 logMar | Standard Deviation 0.066 |
| Somofilcon A at 4 Week | Visual Acuity - Enfilcon A and Somofilcon A | OS | -0.037 logMar | Standard Deviation 0.049 |