Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

Refractive Error Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02886923
• Other study ID #: CR-5856
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: January 23, 2017

Study information

• Verified date: December 2019
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 23, 2017
• Est. primary completion date: January 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 42 Years

Eligibility

Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. The subject must be between 35 and 42 years of age (inclusive).

4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 Diopters (D) to +4.00 D in each eye.

5. The subject's refractive cylinder must be = 0.75 D in each eye.

6. The subject must have best corrected visual acuity of 20/30 or better in each eye.

7. The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of Daily Wear (DW) for a minimum of 1 month prior to the study).

8. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report.

4. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

5. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

6. Any ocular infection.

7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

9. Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.

10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

11. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Hioxifilcon A Test
contact lens made with hioxifilcon A material
• Hioxifilcon A With Cosmetic Ring Control
contact lens made with hioxifilcon A material with a cosmetic ring on the lens

Locations

Country	Name	City	State
United Kingdom	Optometry Technology Group, Ltd.	London

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Binocular Functional Visual Performance Under Distance Day Time Conditions (250 cd/m2) for Centrally Presented High Contrasts (HC) Time Controlled Visual Acuity (TCVA) Targets.	Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 250 cd/m2 luminance. The luminance requirements were same at the target and at the eye.; Binocular functional visual performance was measured for the centrally presented high contrasts targets.	15 minutes post lens fit
Secondary	The Binocular Functional Visual Performance Under Distance Night Time Conditions (2.5 cd/m2) for Centrally Presented HC TCVA Targets.	Time Controlled Visual Acuity (TCVA) was assessed at 4 m using 2.5 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.	15 Minutes post lens fitting
Secondary	The Binocular Functional Visual Performance Under Intermediate Vision Indoor Conditions (50 cd/m2) for Centrally Presented HC TCVA Targets.	Time Controlled Visual Acuity (TCVA) was assessed at 67 cm using 50 cd/m2 luminance. The luminance requirements were same at the target and at the eye. Binocular functional visual performance was measured for the centrally presented high contrasts targets.	15 Minutes post lens fitting