Clinical trial NCT00597467: Study of Soft Contact Lens Use With 7 Day Extended Wear
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Keywords: myopia
hyperopia
extended wear
ametropia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2008-01-18
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 in this open-labeled randomized study.

Eligibility criteria: Inclusion Criteria:

1. Be at least 18 years of age as of the date of evaluation.
2. 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.
3. Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
4. Be in good general health, based on his/her knowledge.
5. Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
6. Possess wearable and visually functional eyeglasses.

Exclusion Criteria:

1. Previously unsuccessful with contact lens wear.
2. Rigid gas permeable contact lens wear within the past 12 months.
3. Previous refractive surgery; current or previous orthokeratology treatment.
4. 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.
5. Aphakia, keratoconus or an irregular cornea.
6. A known history of corneal hypoesthesia
7. Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
8. Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.
9. 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)
10. Known sensitivity to the care systems used in this study.
11. Poor personal hygiene
12. Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.
13. Any active participation in another clinical study within 30 days prior to this study.
14. 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.

Primary outcomes:
measure: Frequency of serious and significant AEs
timeFrame: 1 Year
Secondary outcomes:
measure: Contact Lens Visual Acuity
timeFrame: 1 Year
Other outcomes:
Locations:
city: La Mesa
country: United States
facility: La Mesa Vision Care Center
state: California
city: San Diego
country: United States
facility: (Private Practice)
state: California
city: San Diego
country: United States
facility: Drs. Cook, Reeder and Associates
state: California
city: Santa Monica
country: United States
facility: (Private Practice)
state: California
city: Fort Collins
country: United States
facility: Eye Care Associates, P.C.
state: Colorado
city: Orlando
country: United States
facility: Eola Eyes
state: Florida
city: Honolulu
country: United States
facility: (Private Practice)
state: Hawaii
city: Honolulu
country: United States
facility: Kato & Shoji Optometrists
state: Hawaii
city: Waipahu
country: United States
facility: Eye Care Associates of Hawaii
state: Hawaii
city: Oak Lawn
country: United States
facility: Davis Eyecare Associates
state: Illinois
city: Andover
country: United States
facility: (Private Practice)
state: Massachusetts
city: East Lansing
country: United States
facility: Vision Care Associates
state: Michigan
city: Saint Louis
country: United States
facility: The Koetting Associates Inc.
state: Missouri
city: Concord
country: United States
facility: Concord Ophthalmological Associates
state: New Hampshire
city: Le Roy
country: United States
facility: Place Optical Company Inc
state: New York
city: Athens
country: United States
facility: Quinn Quinn & Associates
state: Ohio
city: Beachwood
country: United States
facility: Western Reserve Vision Care
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Professional Eye Care Associates
state: Ohio
city: Brentwood
country: United States
facility: Primary Eyecare Group, P.C.
state: Tennessee
city: Salt Lake City
country: United States
facility: (Private Practice)
state: Utah
city: Federal Way
country: United States
facility: Twin Lakes Vision
state: Washington
city: Laramie
country: United States
facility: Snowy Range Vision Center
state: Wyoming
Study officials:
affiliation: FRS
name: William Gleason, OD
role: STUDY_DIRECTOR
References: