Evaluation of Two Toric Soft Contact Lenses and a Spherical Soft Contact Lens After Two Weeks of Wear - Full Text View

Sponsors and Collaborators:	Vistakon Foresight Regulatory Strategies, Inc.
Information provided by:	Vistakon
ClinicalTrials.gov Identifier:	NCT00584220

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 comfort, vision and satisfaction after two weeks of use.

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

MedlinePlus related topics: Eye Wear

Drug Information available for: Bionite 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 Investigational Toric Lens in Two Phases: Part B: A Dispensing Cross-Over Comparison to SofLens66 Toric

Further study details as provided by Vistakon:

Primary Outcome Measures:

Patient reported vision satisfaction. [ Time Frame: Baseline, 1-wk and 2-wks ] [ Designated as safety issue: No ]
Patient reported comfort satisfaction. [ Time Frame: Baseline, 1-wk and 2-wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient reported overall satisfaction. [ Time Frame: Baseline, 1-wk and 2-wks ] [ Designated as safety issue: No ]

Enrollment:	93
Study Start Date:	September 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 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

Detailed Description:

Dispensing, single-masked (subject-masked), randomised, 2-visit controlled study of two-weeks duration.

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: NCT00584220

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, O.D.	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.	Unaffilliated
Principal Investigator:	Kevin Rosin, O.D.	Drs. Farkas, Kassalow, Resnick & Associates
Principal Investigator:	Jennifer Kao, O.D.	Unaffiliated

More Information

No publications provided

Responsible Party:	Vistakon ( Kurt Moody, OD, FAAO./ Manager, Clinical Research )
Study ID Numbers:	CR-0714B
Study First Received:	December 20, 2007
Last Updated:	August 14, 2008
ClinicalTrials.gov Identifier:	NCT00584220
Health Authority:	United States: Institutional Review Board

Keywords provided by Vistakon:

Astigmatism
vision
comfort
satisfaction
contact lenses

Study placed in the following topic categories:

Eye Diseases
Refractive Errors
Astigmatism

ClinicalTrials.gov processed this record on February 12, 2009