Status:

COMPLETED

Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

Lead Sponsor:

CooperVision, Inc.

Conditions:

Astigmatism

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

Detailed Description

A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one ...

Eligibility Criteria

Inclusion

  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.
  • Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Currently wears soft contact lenses.
  • Has clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination

Exclusion

  • Has never worn contact lenses before.
  • Has any systemic disease affecting ocular health.
  • Is using any systemic or topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
  • Is aphakic.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.

Key Trial Info

Start Date :

May 6 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 4 2019

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT04016623

Start Date

May 6 2019

End Date

June 4 2019

Last Update

August 14 2020

Active Locations (1)

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Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, United States, 47405

Clinical Evaluation of Invigor Toric 1-Day Contact Lenses | DecenTrialz