N/A N=19 Randomized Double-blind Other

Lens Fitting Evaluation of CooperVision MyDay™ Compared With 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

Myopia

Bottom Line

View on ClinicalTrials.gov: NCT02341859 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2016

Primary outcome: Primary: Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A — 0.42; 0.53; 0.68; 0.47 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: stenfilcon A (Device); delefilcon A (Device); narafilcon A (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: CooperVision, Inc.
Primary completion: Jun 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.97; 0.79; 1.00; 1.29; 1.11; 0.47	—
PRIMARY Conjunctival Staining - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.97; 0.79; 1.00; 1.29; 1.11; 0.47	—
PRIMARY Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.05; 0.16; 0.26; 0.08; 0.18; 0.05	—
PRIMARY Conjunctival Indentation - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.05; 0.16; 0.26; 0.08; 0.18; 0.05	—
PRIMARY Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	1.08; 1.03; 1.05; 1.34; 1.00; 1.03	—
PRIMARY Limbal Redness - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	1.08; 1.03; 1.05; 1.34; 1.00; 1.03	—
PRIMARY Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.00; 0.08; 0.00; 0.03; 0.05; 0.08	—
PRIMARY Corneal Staining Type - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.00; 0.08; 0.00; 0.03; 0.05; 0.08	—
PRIMARY Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.00; 0.03; 0.00; 0.05; 0.11; 0.03	—
PRIMARY Corneal Staining Extent - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.00; 0.03; 0.00; 0.05; 0.11; 0.03	—
PRIMARY Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.00; 0.05; 0.00; 0.05; 0.05; 0.05	—
PRIMARY Corneal Staining Depth - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.00; 0.05; 0.00; 0.05; 0.05; 0.05	—
PRIMARY Corneal Shape Change - Tangential Radius - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	-0.007; -0.004; 0.009; 0.017	—
PRIMARY Corneal Shape Change - Wavefront Error - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0.004; -0.006; -0.006; 0.004	—
PRIMARY Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	19; 19; 19; 18; 0; 0	—
PRIMARY Lens Fit - Corneal Coverage - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	19; 19; 19; 18; 0; 0	—
PRIMARY Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0; 0; 0; 2; 2; 1	—
PRIMARY Lens Fit - Horizontal Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0; 0; 0; 2; 2; 1	—
PRIMARY Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0; 0; 0; 0; 0; 0	—
PRIMARY Lens Fit - Vertical Centration - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0; 0; 0; 0; 0; 0	—
PRIMARY Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0; 0; 0; 0; 0; 0	—
PRIMARY Lens Fit - Post-blink Movement - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	0; 0; 0; 0; 0; 0	—
PRIMARY Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	16; 17; 17; 13; 3; 2	—
PRIMARY Lens Fit - Tightness on up Gaze Blink Lag - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	16; 17; 17; 13; 3; 2	—
PRIMARY Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	18; 18; 19; 13; 1; 1	—
PRIMARY Lens Fit Overall - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	18; 18; 19; 13; 1; 1	—
SECONDARY Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	15; 15; 13; 11; 2; 3	—
SECONDARY Pain and Foreign Body Sensation (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	15; 15; 13; 11; 2; 3	—
SECONDARY Itching Sensation on Insertion (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	15; 17; 18; 16; 4; 2	—
SECONDARY Itching Sensation on Removal (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	15; 16; 15; 14; 4; 3	—
SECONDARY Red Eye (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	19; 19; 17; 16; 0; 0	—
SECONDARY Dryness (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	91.3; 92.5; 93.0; 90.2; 87.8; 87.2	—
SECONDARY Comfort (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	90.0; 92.7; 84.3; 84.6; 90.0; 88.4	—
SECONDARY Handling (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	95.8; 93.0; 90.9; 91.3; 81.6; 86.4	—
SECONDARY Vision (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	90.0; 94.1; 86.5; 90.6; 93.5; 96.8	—
SECONDARY Overall Wearing Satisfaction (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	86.5; 88.6; 86.8; 83.4	—
SECONDARY Lens Preferences (Subjective Rating) - Stenfilcon A/Delefilcon A and Stenfilcon A/Narafilcon A	7; 11; 15; 4	—

Summary

Lens Fitting Evaluation of CooperVision MyDay™ Compared with 1-DAY ACUVUE® TruEye® and DAILIES TOTAL1®

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 soft spherical contact lens wearer
Has a contact lens spherical prescription between -4.00 to - 6.00 and higher than -7.00D (Diopters) (inclusive)
Has a BFS (Best Fit Sphere) that is higher than 8.2 measured and calculated by corneal topography
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
Is willing to comply with the visit schedule

Exclusion Criteria

Is not a habitual wearer of soft spherical contact lenses
Has a contact lens prescription outside the range of the available parameters of the study lenses
Has a contact lens 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 contact lens 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) 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:
Moderate to severe dry eye
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02341859). 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.