Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Handling Comparison Between Two Contact Lens Types

Lead Sponsor:

Johnson & Johnson Vision Care, Inc.

Conditions:

Presbyopia

Eligibility:

All Genders

40-70 years

Phase:

NA

Brief Summary

Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Eligibility Criteria

Inclusion

  • 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 40 and 70 years of age.
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
  • The subject's refractive cylinder must be less than or equal to -0.75 D 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 best corrected visual acuity of 20/20 -3 or better in each eye.
  • Subject must own a wearable pair of spectacles.
  • The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
  • The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion

  • Currently pregnant or lactating (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 systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  • Any ocular abnormality that may interfere with contact lens wear.
  • Use of any ocular medication, with the exception of rewetting drops.
  • Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
  • Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
  • Any ocular infection or inflammation.
  • History of herpetic keratitis.
  • Any corneal distortion or irregular cornea.
  • History of binocular vision abnormality or strabismus.
  • Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
  • Current history of diabetes.
  • Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Key Trial Info

Start Date :

November 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2014

Estimated Enrollment :

195 Patients enrolled

Trial Details

Trial ID

NCT02310126

Start Date

November 1 2014

End Date

December 1 2014

Last Update

June 19 2018

Active Locations (8)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (8 locations)

1

Baymeadows Vision Center

Jacksonville, Florida, United States, 32256

2

Eye Elements Eyecare

Jacksonville, Florida, United States, 32256

3

Vistakon Research Clinic

Jacksonville, Florida, United States, 32256

4

Golden Family Eyecare

Sarasota, Florida, United States, 34232