Study of Soft Contact Lens Use With 7 Day Extended Wear - Full Text View

Sponsor:	Coopervision, Inc.
Information provided by:	Coopervision, Inc.
ClinicalTrials.gov Identifier:	NCT00597467

Purpose

To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.

Condition	Intervention	Phase
Ametropia	Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens Device: Acuvue 2 Soft Contact Lens	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

Drug Information available for: Silicone

U.S. FDA Resources

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:

Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial [ Time Frame: Pre-dispensing, dispensing and 24 hr, 1 week, and months 1, 2, 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Non-significant adverse events; discontinuations; slit lamp findings; subjective symptoms, problems and complaints; keratometric and refractive changes; and best-corrected visual acuity [ Time Frame: Pre-dispensing, dispensing and 24 hr, 1 week, and months 1, 2, 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ]

Enrollment:	455
Study Start Date:	March 2006
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens Test device
2: Active Comparator	Device: Acuvue 2 Soft Contact Lens Control device

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Be at least 18 years of age as of the date of evaluation.
Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.
Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
Be in good general health, based on his/her knowledge.
Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
Possess wearable and visually functional eyeglasses.

Exclusion Criteria:

Previously unsuccessful with contact lens wear.
Rigid gas permeable contact lens wear within the past 12 months.
Previous refractive surgery; current or previous orthokeratology treatment.
Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.
Aphakia, keratoconus or an irregular cornea.
A known history of corneal hypoesthesia
Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.
Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- History of corneal ulcer, corneal infiltrates or fungal infections.
- Pterygium, pinguecula or corneal scars within the visual axis
- Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia)
- Neovascularization or ghost vessels > 1mm in from the limbus
- Seborrheic eczema, seborrheic conjunctivitis
- History of papillary conjunctivitis greater than Grade 2 (Mild)
- Anterior uveitis or iritis (past or present)
Known sensitivity to the care systems used in this study.
Poor personal hygiene
Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.
Any active participation in another clinical study within 30 days prior to this study.
Subject is a member, relative or household member of the office staff, including the investigator(s).

Subjects must read, indicate understanding of, and sign the Informed Consent Form.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597467

Show 23 Study Locations

Sponsors and Collaborators

Coopervision, Inc.

Investigators

Study Director:

William Gleason, OD

FRS

More Information

No publications provided

Responsible Party:	Coopervision, Inc. ( Lisa Hahn )
Study ID Numbers:	CVI060105
Study First Received:	December 27, 2007
Last Updated:	December 19, 2008
ClinicalTrials.gov Identifier:	NCT00597467 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Coopervision, Inc.:

myopia
hyperopia
extended wear
ametropia

Additional relevant MeSH terms:

Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on February 08, 2010