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OpenTrials
Completed

NCT Number: NCT02568254

Evaluation of Three Daily Disposable Contact Lenses

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Lens 1 (etafilcon A)

Device

Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Other names: 1-Day Acuvue® Moist®

Lens 2 (nelfilcon A)

Device

Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Other names: Dailies® AquaComfort Plus®

Lens 3 (nesofilcon A)

Device

Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).

Other names: Biotrue ONEday

Primary outcomes

  1. Overall Comfort

    Time frame: 2- Week Follow-up

    Clue comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2015
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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