Clinical Performance of Habitual Wearers of Bioclear 1-day Lenses When Refitted With Biomedics 1-day Extra for 1 Week

Not Applicable

Completed

Conditions: Myopia
Hyperopia

Interventions: Device: filcon IV 1
Device: ocufilcon D

Registration Number: NCT02406495

Lead Sponsor: Coopervision, Inc.

Brief Summary: Open label, 1-week daily disposable, dispensing study

Detailed Description: Evaluate the clinical performance of habitual wearers of FILCON IV 1 sphere lenses when refitted with ocufilcon D asphere for 1 week of daily disposable wear.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
filcon IV 1 and ocufilcon D	ocufilcon D	Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.
filcon IV 1 and ocufilcon D	filcon IV 1	Habitual wearers of filcon IV 1 sphere lenses refitted with asphere ocufilcon D lenses.

Primary Outcome Measures

Name	Time	Method
Lens Fit, Post-blink Movement - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens fit, post-blink movement for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Lens Fit, Lens Tightness - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens fit, lens tightness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0%-100% continuous scale 0% - Falls from cornea without lid support 50% - Optimum 100% - No movement
Lens Fit, Centration - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens fit, centration for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale: optimum, decentration acceptable, and decentration unacceptable
Lens Fit, Overall Fit Acceptance - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens fit, overall fit acceptance for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 0-4, 0=Should not be worn, 4=Perfect.

Secondary Outcome Measures

Name	Time	Method
Handling (Subjective Ratings) - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Subjective ratings of handling for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=very difficult to handle, 10=very easy to handle).
Visual Acuity - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Visual acuity for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week using logMAR chart (a logMAR of 0.0=20/20 in Snellen notation and negative values indicate better visual acuity).
Comfort (Subjective Ratings) - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Subjective ratings for comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=could feel, 10=cannot feel).
Dryness (Subjective Ratings) - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Subjective ratings of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dryness, 10=no dryness).
Vision Satisfaction (Subjective Ratings) - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Subjective ratings of vision satisfaction for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. (Scale 0-10, 0=dissatisfied, 10=very satisfied).
Lens Preference (Subjective Ratings) - Filcon IV 1 and Ocufilcon D	1 Week	Subjective ratings of participant's lens preference for either filcon IV 1 or ocufilcon D on comfort, dryness, handling, vision, and overall. Forced choice: filcon IV 1 or ocufilcon D.
Lens Satisfaction, Comfort - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens satisfaction of comfort for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Dryness - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens satisfaction of dryness for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Handling - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens satisfaction of handling forfilcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Vision - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens satisfaction of vision for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.
Lens Satisfaction, Overall - Filcon IV 1 and Ocufilcon D	Baseline and 1 Week	Lens satisfaction overall for filcon IV 1 assessed at baseline and ocufilcon D assessed at 1 week. Scale 1-4, 1=completely satisfied, 4=completely dissatisfied.