Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00597467
Other study ID # CVI060105
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04532099 - Clinical Comparison of Two Daily Wear Frequent Replacement Silicone Hydrogel Soft Contact Lenses N/A
Completed NCT03319212 - Clinical Characterization of Symptomatic Populations N/A
Withdrawn NCT04525170 - Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A N/A
Completed NCT05483127 - Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses N/A
Completed NCT01741987 - Osmoprotective Containing Lubricants in Dysfunctional Tear Syndrome and Post Refractive Surgery Patients N/A
Completed NCT03688672 - Apioc Contact Lens Feasibility N/A
Completed NCT02312323 - One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses N/A
Recruiting NCT04714424 - Comparing Vision Tests in a Virtual Reality Headset to Existing Analogues
Recruiting NCT04632784 - Clinical Trial With Artiflex Presbyopic N/A
Completed NCT04185701 - Comparison of Subjective Refraction Measurement With SiVIEW Software and by an Expert N/A
Completed NCT01706770 - Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens N/A
Completed NCT03556579 - The Effects of Contact Lenses With Experimental Dye on Visual Function N/A
Completed NCT04654455 - Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
Not yet recruiting NCT06295536 - Optimization of a Photoretinoscopy Method for Determining the Objective Refraction of Children N/A
Completed NCT00691197 - Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear Phase 2/Phase 3
Completed NCT04067141 - The Clinical Comparison of Somofilcon A 1 Day and Nelfilcon A Daily Disposable Contact Lenses N/A
Completed NCT04067050 - A Clinical Study of the Comfilcon A Asphere Soft Contact Lens in Users of Digital Devices N/A
Completed NCT02553681 - Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D N/A
Completed NCT00722891 - Ocular Responses to Short and Long-term Lens Wear N/A
Completed NCT00349063 - Contact Lens Wettability Phase 4