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OpenTrials
Completed

NCT Number: NCT03059810

Clinical Evaluation of Investigational Multifocal Contact Lenses

3-visit dispensing study to evaluate the subjective feedback of a multifocal contact lens in a population of presbyopic patients. Subjects will wear the contact lenses for a total of 12-16 days.

Completed

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EYE Center Optometric, Rocklin, California, United States

Loading trial locations.

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.
  • Healthy adult males or females that are at least 40 years of age and no more than 70 years of age.
  • The subject must either be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not, respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".(Appendix B).
  • The subject is a current soft spherical or toric contact lens wearer (defined as a minimum of 6 hours of wear per day at least two days of the week for a minimum of 1 month prior to the study).
  • The subject's refractive spherical component must be between +1.25 Diopters (D) to +3.75 D in each eye.
  • The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye.
  • The subject's refractive cylinder axis must be 90°±30° or 180°±30° in each eye.
  • The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  • The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.
  • The subject must have a wearable pair of spectacles if required for their distance vision.

Exclusion criteria

  • Ocular or systemic allergies or disease, or use of medication which might interfere with contact lens wear.
  • Pregnancy or lactation.
  • Currently diagnosed with diabetes.
  • Infectious diseases (e.g. hepatitis, tuberculosis) or an immune-suppressive disease (e.g. HIV).
  • Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
  • Any previous, or planned, ocular or intraocular surgery (e.g.radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), lid procedures, cataract surgery, retinal surgery, etc.).
  • A history of amblyopia, strabismus or binocular vision abnormality.
  • Any ocular infection or inflammation.
  • Any ocular abnormality that may interfere with contact lens wear.
  • Use of any ocular medication, with the exception of rewetting drops.
  • History of herpetic keratitis.
  • Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Treatment and study plan

etafilcon A

Device

Investigational Contact Lens

Primary outcomes

  1. Overall Vision

    Time frame: 12-16 Day Follow-up

    Overall vision 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
2017
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2017
Registry last updated
Dec 24, 2019

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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