Study of Soft Contact Lens Use With 7 Day Extended Wear

Ametropia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597467
• Other study ID #: CVI060105
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Est. completion date: November 2007

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• VISA (comfilcon A) Silicone Hydrogel Soft contact lens
Test device
• Acuvue 2 Soft Contact Lens
Control device

Locations

Country	Name	City	State
United States	(Private Practice)	Andover	Massachusetts
United States	Quinn Quinn & Associates	Athens	Ohio
United States	Western Reserve Vision Care	Beachwood	Ohio
United States	Primary Eyecare Group, P.C.	Brentwood	Tennessee
United States	Ohio State University	Columbus	Ohio
United States	Professional Eye Care Associates	Columbus	Ohio
United States	Concord Ophthalmological Associates	Concord	New Hampshire
United States	Vision Care Associates	East Lansing	Michigan
United States	Twin Lakes Vision	Federal Way	Washington
United States	Eye Care Associates, P.C.	Fort Collins	Colorado
United States	(Private Practice)	Honolulu	Hawaii
United States	Kato & Shoji Optometrists	Honolulu	Hawaii
United States	La Mesa Vision Care Center	La Mesa	California
United States	Snowy Range Vision Center	Laramie	Wyoming
United States	Place Optical Company Inc	Le Roy	New York
United States	Davis Eyecare Associates	Oak Lawn	Illinois
United States	Eola Eyes	Orlando	Florida
United States	The Koetting Associates Inc.	Saint Louis	Missouri
United States	(Private Practice)	Salt Lake City	Utah
United States	(Private Practice)	San Diego	California
United States	Drs. Cook, Reeder and Associates	San Diego	California
United States	(Private Practice)	Santa Monica	California
United States	Eye Care Associates of Hawaii	Waipahu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of serious and significant AEs	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	1 Year
Secondary	Contact Lens Visual Acuity	Contact lens visual acuity was assessed using LogMAR	1 Year