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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vistakon
ClinicalTrials.gov Identifier:
NCT01120782
First received: May 4, 2010
Last updated: November 4, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Astigmatism
 Device: etafilcon A toric contact lens with new wetting agent
Device: etafilcon A toric contact lens

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Vistakon:

Primary Outcome Measures:
  • Prescription Equivalence [ Time Frame: after 15 minutes of lens wear ] [ Designated as safety issue: No ]
    Number of subjects whose prescription is the same for the two lenses tested.


Enrollment: 45
Study Start Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: etafilcon A toric new lens/etafilcon A toric lens
The lens worn first is a new etafilcon A toric contact lens and the lens worn second is a marketed etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
 Device: etafilcon A toric contact lens with new wetting agent
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
Device: etafilcon A toric contact lens
Marketed toric contact lens made of etafilcon A material.
Active Comparator: etafilcon A toric lens/etafilcon A toric new lens
The lens worn first is a marketed etafilcon A toric contact lens and the lens worn second is a new etafilcon A toric contact lens. Each lens worn for a maximum of 15 minutes bilaterally.
 Device: etafilcon A toric contact lens with new wetting agent
Investigational toric contact lens made of etafilcon A material with a new wetting agent.
Device: etafilcon A toric contact lens
Marketed toric contact lens made of etafilcon A material.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Ocular or systemic allergies or disease that may interfere with contact lens wear.
  2. Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.
  3. Clinically significant corneal edema, corneal vascularization, corneal staining or any other abnormality of the cornea, which may contraindicate contact lens wear.
  4. Clinically significant tarsal abnormalities that might interfere with contact lens wear.
  5. Any ocular infection.
  6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  7. Pregnancy or lactation
  8. Any infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
  9. Diabetes
  10. Strabismus -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120782

Locations
United States, Florida
Jacksonville, Florida, United States
United States, New York
New York, New York, United States
Sponsors and Collaborators
Vistakon
  More Information

No publications provided

Responsible Party: Vistakon
ClinicalTrials.gov Identifier: NCT01120782     History of Changes
Other Study ID Numbers: CR-1476AI
Study First Received: May 4, 2010
Results First Received: November 4, 2011
Last Updated: November 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Astigmatism
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013