N/A
N=40
Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week
Myopia · Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT02406495 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2016
Primary outcome: Primary: Lens Fit, Centration - Filcon IV 1 and Ocufilcon D — 58; 70; 98; 98 percentage of eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- filcon IV 1 (Device); ocufilcon D (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit, Centration - Filcon IV 1 and Ocufilcon D |
58; 70; 98; 98; 43; 30 | — |
| PRIMARY Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D |
0; 0; 0; 0; 10; 10 | — |
| PRIMARY Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D |
49.1; 50.1; 48.9; 50.0 | — |
| PRIMARY Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Visual Acuity - Filcon IV 1 and Ocufilcon D |
0; 0; 0; 0; -0.01; -0.01 | — |
| SECONDARY Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D |
7.4; 8.1; 7.3; 8.1; 7.3; 8.1 | — |
| SECONDARY Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D |
7.2; 8.0; 7.3; 8.0; 7.3; 8.1 | — |
| SECONDARY Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D |
7.4; 8.2 | — |
| SECONDARY Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D |
7.5; 8.2 | — |
| SECONDARY Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D |
20; 80; 20; 80; 20; 80 | — |
| SECONDARY Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D |
20; 60; 68; 35; 13; 5 | — |
| SECONDARY Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D |
20; 60; 65; 35; 15; 5 | — |
| SECONDARY Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D |
23; 60; 65; 38; 13; 3 | — |
| SECONDARY Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D |
23; 60; 65; 38; 13; 3 | — |
| SECONDARY Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D |
20; 60; 68; 35; 13; 5 | — |
Summary
Open label, 1-week daily disposable, dispensing study
Eligibility Criteria
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 wearer (at least 1 week in Avaira sphere)
- Has a contact lens spherical prescription between + 2.25 to - 8.00 (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 CL 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
Data sourced from ClinicalTrials.gov (NCT02406495). 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.