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N/A N=74 Randomized Double-blind Prevention

Evaluation of Three Daily Disposable Contact Lenses

Visual Acuity

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

OutcomeResultp-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).
View full record on ClinicalTrials.gov →

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.

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