In-Office Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens - Full Text View

Sponsors and Collaborators:	Vistakon Foresight Regulatory Strategies, Inc.
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00584727

Purpose

The purpose of this study is to determine the relative performance of a new toric soft contact lens against a toric and a spherical contact lens currently available in market, specifically with regards to the fit and visual acuity as well as the comfort, vision and satisfaction while in the practitioner's office. Approx 2 hours duration.

Condition	Intervention
Astigmatism	Device: senofilcon A toric contact lens Device: SofLens toric contact lens Device: Acuvue 2

MedlinePlus related topics: Eye Wear

Drug Information available for: Senofilcon A

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Crossover Assignment
Official Title:	Evaluation of Fit and Visual Acuity of the Cypress Toric Lens in Two Phases: Part A: A Non-Dispensing Comparison to SofLens66® Toric and Acuvue® 2

Further study details as provided by Vistakon:

Primary Outcome Measures:

Visual acuity [ Time Frame: baseline and after fit of each of the three lens types ] [ Designated as safety issue: No ]
Patient reported vision satisfaction [ Time Frame: baseline and after fit of each of the three lens types ] [ Designated as safety issue: No ]
Lens orientation [ Time Frame: baseline and after fit of each of the three lens types ] [ Designated as safety issue: No ]
Lens stability [ Time Frame: baseline and after fit of each of the three lens types ] [ Designated as safety issue: No ]
Patient reported comfort. [ Time Frame: baseline and after fit of each of the three lens types ] [ Designated as safety issue: No ]
Patient Preference [ Time Frame: after all three lens are fitted ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Lens movement [ Time Frame: after fit of each of the three lens types ] [ Designated as safety issue: No ]
Lens centration [ Time Frame: after fit of each of the three lens types ] [ Designated as safety issue: No ]
Limbal coverage [ Time Frame: after fit of each of the three lens types ] [ Designated as safety issue: No ]
Lens Fit success [ Time Frame: after fit of each of the three lens types ] [ Designated as safety issue: No ]
Successful lens Rx via phoropter as compared to autorefracto [ Time Frame: after fit of each of the three lens types ] [ Designated as safety issue: No ]

Enrollment:	96
Study Start Date:	September 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental senofilcon A toric contact lens	Device: senofilcon A toric contact lens contact lens
2: Active Comparator SofLens toric contact lens	Device: SofLens toric contact lens contact lens
3: Active Comparator Acuvue2 contact lens	Device: Acuvue 2 contact lens

Detailed Description:

Non-dispensing, single-masked (subject-masked), randomised, controlled study.

Eligibility

Ages Eligible for Study:	18 Years to 39 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy
have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
be able and willing to adhere to the instructions set forth in the protocol.
agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
be in good general health, based on his/her knowledge.
read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion Criteria:

The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium or corneal scars within the visual axis
- Neovascularization >1mm in from the limbus
- History of giant papillary conjunctivitis (GPC) worse than Grade 2
- Anterior uveitis or iritis (past or present)
- Seborrhoeic eczema, seborrhoeic conjunctivitis
A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
A known history of corneal hypoesthesia (reduced corneal sensitivity.)
Aphakia, keratoconus or a highly irregular cornea.
Current pregnancy or lactation (to the best of the subject's knowledge).
Active participation in another clinical study at any time during this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00584727

Sponsors and Collaborators

Vistakon

Foresight Regulatory Strategies, Inc.

Investigators

Principal Investigator:	Jason Chin, O.D.	Unaffiliated
Principal Investigator:	James Fujimoto, O.D.	Unaffiliated
Principal Investigator:	Weslie Hamada, OlD.	Arthur T. Kobayashi, O.D., Inc.
Principal Investigator:	Dennis Kuwuabara, O.D.	Eye Care Associates of Hawaii
Principal Investigator:	Mark Nakano, O.D.	Mark E. Nakano Optometric Corp.
Principal Investigator:	Ikuko Sugimoto, O.D.	Unaffiliated
Principal Investigator:	Kevin Rosin, O.D.	Drs. Farkas, Kassalow, Resnick & Associates
Principal Investigator:	Jennifer Kao, O.D.	Unaffiliated

More Information

Responsible Party:	Vistakon ( Kurt Moody, OD, FAAO./ Manager, Clinical Research )
Study ID Numbers:	CR-0714A
Study First Received:	December 20, 2007
Last Updated:	December 31, 2007
ClinicalTrials.gov Identifier:	NCT00584727
Health Authority:	United States: Institutional Review Board

Keywords provided by Vistakon:

astigmatism
visual acuity
fit

comfort
satisfaction
contact lens

Study placed in the following topic categories:

Eye Diseases
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on January 16, 2009