Study of Soft Contact Lens Use With 7 Day Extended Wear

Not Applicable

Completed

• Conditions: Ametropia
• Interventions: Device: Acuvue 2 Soft Contact Lens; Device: VISA (comfilcon A) Silicone Hydrogel Soft contact lens

• Registration Number: NCT00597467
• Lead Sponsor: Coopervision, Inc.

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.

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-18
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-15
• Last Update Posted: 2020-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Contact Lenses	Acuvue 2 Soft Contact Lens	Acuvue 2 Soft Contact Lens
Test Contact Lenses	VISA (comfilcon A) Silicone Hydrogel Soft contact lens	VISA (comfilcon A) Silicone Hydrogel Soft contact lens

Primary Outcome Measures

Name	Time	Method
Frequency of serious and significant AEs	1 Year	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

Secondary Outcome Measures

Name	Time	Method
Contact Lens Visual Acuity	1 Year	Contact lens visual acuity was assessed using LogMAR

Trial Locations

Locations (19)

Concord Ophthalmological Associates; 🇺🇸 Concord, New Hampshire, United States

Primary Eyecare Group, P.C.; 🇺🇸 Brentwood, Tennessee, United States

The Koetting Associates Inc.; 🇺🇸 Saint Louis, Missouri, United States

Vision Care Associates; 🇺🇸 East Lansing, Michigan, United States

Western Reserve Vision Care; 🇺🇸 Beachwood, Ohio, United States

Place Optical Company Inc; 🇺🇸 Le Roy, New York, United States

Eye Care Associates of Hawaii; 🇺🇸 Waipahu, Hawaii, United States

Snowy Range Vision Center; 🇺🇸 Laramie, Wyoming, United States

Eye Care Associates, P.C.; 🇺🇸 Fort Collins, Colorado, United States

La Mesa Vision Care Center; 🇺🇸 La Mesa, California, United States

(Private Practice); 🇺🇸 Salt Lake City, Utah, United States

Davis Eyecare Associates; 🇺🇸 Oak Lawn, Illinois, United States

Professional Eye Care Associates; 🇺🇸 Columbus, Ohio, United States

Eola Eyes; 🇺🇸 Orlando, Florida, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Drs. Cook, Reeder and Associates; 🇺🇸 San Diego, California, United States

Kato & Shoji Optometrists; 🇺🇸 Honolulu, Hawaii, United States

Quinn Quinn & Associates; 🇺🇸 Athens, Ohio, United States

Twin Lakes Vision; 🇺🇸 Federal Way, Washington, United States