CompletedInterventionalNot ApplicableUpdated May 21, 2015
Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types | NCT01120782 | Trialant
CompletedInterventionalNot ApplicableUpdated Jun 19, 2018
Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
ClinicalTrials.gov ID
NCT01120782
Lead Sponsor
Johnson & Johnson Vision Care, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
45Actual
Last Update Posted
Jun 19, 2018Actual
Start Date
Feb 1, 2010Actual
Primary Completion Date
Feb 1, 2010Actual
Completion Date
Feb 1, 2010Actual
Brief Summary
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.
Astigmatism
etafilcon A toric contact lens with new wetting agent
etafilcon A toric contact lens
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).