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OpenTrials
Completed

NCT Number: NCT02595502

Clinical Evaluation of Two Silicone Hydrogel Daily Disposable Contact Lenses

The purpose of this investigation is to evaluate the short-term, clinical performance of two silicone hydrogel daily disposable contact lenses.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Becky Bizzle, OD, Montgomery, Alabama, United States

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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 between (and including) 18 and 39 years of age.
  • The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day worn for at least 30 days immediately preceding the study.
  • The subject must have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -0.50 to -6.00 Diopters (D) in each eye.
  • The subject must have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion criteria

  • Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
  • Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  • Any autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Monovision, multi-focal, toric, or extended wear contact lens correction.
  • Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  • History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.

Treatment and study plan

JJVC Marketed Contact Lens (Test)

Device

Other names: senofilcon A

Competitor Marketed Contact Lens (Control)

Device

Other names: delefilcon A

Primary outcomes

  1. Overall Comfort

    Time frame: 1 Week

    Overall 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. Please note this was a 2 treatment by 3 period study design. Therefore, some subjects were randomized to receive one of the study lenses twice, hence the number of observations were summarized per lens type. For the senofilcon A lens 134+138+134=406 (Observations- 1 per subject per period, however 1 observation was not recorded) from period 1, 2 and 3 respectively. For the delefilcon A lens 138+134+138=410 from period 1, 2 and 3 respectively.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2015
Registry last updated
Jul 5, 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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