N/A
N=74
Evaluation of Three Daily Disposable Contact Lenses
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT02568254 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Overall Comfort — 58.74; 48.14; 57.32 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lens 1 (etafilcon A) (Device); Lens 2 (nelfilcon A) (Device); Lens 3 (nesofilcon A) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort |
58.74; 48.14; 57.32 | — |
Summary
This is a single-site, 8-visit, double-masked, cross-over study involving three marketed products as study lenses. Participants will be randomly assigned each lens type, which will be worn for approximately two weeks (12 +/- 2 days) each. Participants will undergo a minimum washout period of 3 days before entering the study and undergo a minimum 7 day washout period between dispensing each lens type.
Eligibility Criteria
Inclusion Criteria
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form;
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol;
- The subject must be willing and able to follow instructions and maintain the appointment schedule;
- The subject must be between the age of 18 and 40 years (inclusive);
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of -0.50 Diopters (D) to -6.00 D in each eye (inclusive);
- The subject's refractive cylinder must not exceed -1.25 Diopters of Cylinder (DC) in each eye after vertexing to the corneal plane;
- The subject must have best corrected visual acuity of 0.2 Logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye;
- The subject must be a current wearer of spherical, soft contact lenses (no toric, bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 8 hours/day during the month prior to enrollment;
- The subject must own a wearable pair of spectacles and wear them the day of the initial visit;
- The subject must be an existing wearer of spherical, soft contact lenses in both eyes;
- The subject must have normal eyes (i.e., no ocular medications or infections of any type);
- The subject must be willing to wear the study lenses for a minimum eight hours per day.
Exclusion Criteria
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear (at the investigator's discretion);
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear (at the investigator's discretion);
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued);
- Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease;
- Any active ocular infection;
- Is using any topical medications (excluding artificial tears (ATS)) up to two weeks prior to the screening visit;
- Any participants whose habitual contact lenses are used as an extended wear regimen;
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry;
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.);
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear; or clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear;
- Any known hypersensitivity or allergic reaction to the study products;
- Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment;
- Employee or family member of the Centre for Contact Lens Research (e.g., Investigator, Coordinator, Technician).
Data sourced from ClinicalTrials.gov (NCT02568254). 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.