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

Tracking Information
First Received Date ^ICMJE	May 4, 2010
Last Updated Date	November 4, 2011
Start Date ^ICMJE	February 2010
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 4, 2011)	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.
Original Primary Outcome Measures ^ICMJE (submitted: May 10, 2010)	contact lens prescription assessment [ Time Frame: after 15 minutes of lens wear ] [ Designated as safety issue: No ] This outcome measure will compare the final prescription for both lens types.
Change History	Complete list of historical versions of study NCT01120782 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Non-dispensing Study to Check Prescription Equivalence of Two Daily Disposable Toric Contact Lens Types
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Astigmatism
Intervention ^ICMJE	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.
Study Arm (s)	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. Interventions: Device: etafilcon A toric contact lens with new wetting agent Device: etafilcon A toric contact lens 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. Interventions: Device: etafilcon A toric contact lens with new wetting agent Device: etafilcon A toric contact lens
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	45
Completion Date	Not Provided
Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 -
Gender	Both
Ages	18 Years to 40 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01120782
Other Study ID Numbers ^ICMJE	CR-1476AI
Has Data Monitoring Committee	No
Responsible Party	Vistakon
Study Sponsor ^ICMJE	Vistakon
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vistakon
Verification Date	November 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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