Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Coopervision, Inc.
- Enrollment
- 106
- Primary Endpoint
- Dryness
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A
This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
Detailed Description
The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A. The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses. Study groups: Group 1: stenfilcon A vs. narafilcon A Group 2: stenfilcon A vs. delefilcon A
Investigators
Eligibility Criteria
Inclusion Criteria
- •A person is eligible for inclusion in the study if he/she:
- •Is over 18 years of age (inclusive)
- •Has had a self-reported visual exam in the last two years
- •Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
- •Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
- •Can achieve a distance visual acuity of 20/30 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.
- •Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
- •Is willing to comply with the wear schedule.
Exclusion Criteria
- •A person will be excluded from the study if he/she:
- •Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
- •Has a CL prescription outside the range of the inclusion power range
- •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 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
- •Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Outcomes
Primary Outcomes
Dryness
Time Frame: 1 week
Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.
Comfort
Time Frame: 1 week
Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).
Vision
Time Frame: 1 week
Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).
Handling
Time Frame: 1 week
Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)
Time Frame: 1 week
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)
Time Frame: 1 week
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).
Pain and Foreign Body Sensation
Time Frame: 1 week
Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Itching Sensation on Removal
Time Frame: 1 week
Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Red Eye Sensation
Time Frame: 1 week
Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Secondary Outcomes
- Lens Fit - Horizontal Centration(1 week)
- Corneal Staining(1 week)
- Lens Fit - Vertical Centration(1 week)
- Lens Fit - Post-blink Movement(1 week)
- Lens Fit Overall(1 week)
- Conjunctival Redness(1 week)
- Limbal Redness(1 week)
- Corneal Neovascularization(1 week)
- Conjunctival Staining(1 week)
- Corneal Oedema(1 week)
- Papillary Conjunctivitis(1 week)