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OpenTrials
Completed

NCT Number: NCT01120782

Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types

The purpose of this study is to determine whether the prescription determined for a new daily disposable toric contact lens will be a good match to a prescription determined for an existing brand of lens.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject must be between 18 and 40 years old.
  • The subject must have normal eyes.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.
  • The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00 DS in each eye.
  • The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.
  • The subject's refractive cylinder axis must be 180 +/- 30 in each eye.
  • The subject must be an adapted wearer of soft toric contact lenses in both eyes.
  • The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.
  • Subjects must already possess a wearable pair of spectacles. -

Exclusion criteria

  • Ocular or systemic allergies or disease that may interfere with contact lens wear.
  • Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
  • Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
  • Clinically significant tarsal abnormalities that might interfere with contact lens wear.
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Pregnancy or lactation
  • Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  • Diabetes
  • Strabismus -

Treatment and study plan

etafilcon A toric contact lens with new wetting agent

Device

Investigational toric contact lens made of etafilcon A material with a new wetting agent.

Etafilcon A toric contact lens

Device

Marketed toric contact lens made of etafilcon A material.

Primary outcomes

  1. Prescription Equivalence

    Time frame: after 15 minutes of lens wear

    Number of subjects whose prescription is the same for the two lenses tested.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 11, 2010
Registry last updated
Jun 19, 2018

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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