N/A
N=77
Performance of Wearers of Stenfilcon A Contact Lenses After A Refit With Test Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03496701 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Overall Lens Fit Acceptance — 3.90; 3.81 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test lens (Device); control lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Lens Fit Acceptance |
3.79; 3.83 | — |
| PRIMARY Overall Lens Fit Acceptance |
3.79; 3.83 | — |
| SECONDARY Lens Centration |
75; 76; 2; 1; 0; 0 | — |
| SECONDARY Lens Centration |
75; 76; 2; 1; 0; 0 | — |
| SECONDARY Post-blink Movement |
1.92; 1.96 | — |
| SECONDARY Post-blink Movement |
1.92; 1.96 | — |
Summary
The aim of this study is to determine if habitual or adapted wearers of stenfilcon A control contact lenses can be refit into test lenses and be successful after one week of daily wear.
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 35 years of age (inclusive)
- Has read and signed the informed consent letter
- Is willing and anticipated to follow instructions and maintain the appointment schedule
- Habitually wears soft spherical contact lenses with a power between -1.00D to -6.00D (inclusive) for a minimum 5 days per week, 10 hours per day and anticipates no difficulty wearing contact lenses for 7 days per week, 10 hours per day.
- Habitually wears or is able to be adequately refit into MyDay Sphere lenses
- Demonstrates an acceptable fit with the study lenses
- Is correctable to a distance visual acuity of 0.20 logMAR (approximately 20/30) or better (in each eye) with the study contact lenses
- Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.
- Manifest cylindrical spectacle refraction does not exceed -0.75DC in either eye
- Has clear corneas and no active ocular disease
- Has a contact lens refraction that fits within the available parameters of the study lenses.
Exclusion Criteria
A person will be excluded from the study if he/she:
- Is participating in any concurrent clinical research study
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has a systemic condition that, in the opinion of the investigator, may affect the study measures
- Is using any systemic or topical medications that in the opinion of the investigator may affect the study measures.
- Presents with slit lamp findings or clinically significant anterior segment abnormalities that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Significant 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 (or history in past year)
- Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has a known sensitivity to the diagnostic pharmaceuticals to be used in the study
- Has aphakia, keratoconus or a highly irregular cornea.
- Has presbyopia or has dependence on spectacles for near work over the contact lenses.
- Has undergone refractive surgery.
- Is pregnant, lactating or planning a pregnancy (by verbal communication) at the time of enrollment
- Has participated in any other type of eye related clinical or research study within the last 7 days
- Is habitually using rewetting/ lubricating eye drops (more than once per day)
Data sourced from ClinicalTrials.gov (NCT03496701). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.