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Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status

Completed

Conditions

Astigmatism

Treatments

Device: Nelfilcon A toric contact lens
Device: Etafilcon A toric contact lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT01055132
CR-1476AG

Details and patient eligibility

About

The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Enrollment

70 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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 -5.00D 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 degrees plus or minus 30 degrees 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 (grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
  • Clinically significant (grade 3 or 4) 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

70 participants in 2 patient groups

Etafilcon A toric contact lens/Nelfilcon A toric
Other group
Description:
Etafilcon A toric contact lens first, then nelfilcon A toric second
Treatment:
Device: Nelfilcon A toric contact lens
Device: Etafilcon A toric contact lens
Nelfilcon A toric/ Etafilcon A toric
Other group
Description:
Nelfilcon A toric contact lens first, then etafilcon A toric toric second
Treatment:
Device: Nelfilcon A toric contact lens
Device: Etafilcon A toric contact lens

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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