This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.
This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Daily disposable contact lens worn in a daily wear, daily disposable mode
Eric M. White, OD, Inc.
San Diego, California, United States
Vision Care Associates
East Lansing, Michigan, United States
Western Reserve Vision Care
Beachwood, Ohio, United States
Primary Eyecare Group, P.C.
Brentwood, Tennessee, United States
Objective Assessment: Ocular Response - Biomicroscopy
The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.
Time frame: Change from baseline visit and all follow-ups visits
Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).
Time frame: Any occurrence from dispensing to month 3 visit
Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.
Time frame: week 1 visit, week 2 visit, month 1 visit, month 2 visit combined
Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort
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The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens. Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3
Evaluation of Average Lens Wearing Time - Average Daily Hours Worn
The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.
Time frame: Baseline, Week 1, Week 2, Month 1, Month 2, Month 3