Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

Refractive Errors Clinical Trial

Official title:

Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444313
• Other study ID #: CR-201009
• Status: Completed
• Phase: N/A
• Start date: January 2011

Study information

• Verified date: October 2014
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject is an adapted soft contact lens wearer

• The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye

• The subject must have a refractive astigmatism in each eye of -0.75D or less

• The subject must have a best corrected visual acuity of 6/9 or better in each eye.

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

• The subject must read and sign the statement of informed consent

• The subject must be at least 18 years of age

Exclusion Criteria:

• Systemic or ocular allergies which might interfere with contact lens wear

• Systemic disease which might interfere with contact lens wear

• Ocular disease which might interfere with contact lens wear

• Grade 3 or 4 Slit Lamp Findings

• Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit

• On changing stable medication or taking any medication known to affect tear film

• Active ocular surface pathology

• Use ocular medication

• Had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study

• Significant ocular tissue anomaly

• Presence of two or more corneal scars in either eye

• Pregnancy or lactation, or intends to become pregnant during the time period of the study

• Any medical condition that may be prejudicial to the study

• Diabetes

• Infectious diseases (e.g. Hepatitis, tuberculosis)

• Contagious immunosuppressive diseases (e.g. HIV)

Related Conditions & MeSH terms

• Refractive Errors

Intervention

Device:
• narafilcon A contact lens
Soft contact lenses with UV protection
• nelfilcon A soft contact lenses
Soft contact lenses without UV protection

Locations

Country	Name	City	State
n/a

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	Macular Pigment Optical Density at 9 months		baseline to 9 months
Primary	Macular Pigment Optical Density at 15 months		baseline to 15 months
Secondary	Macular Pigment Optical Density at 3 months		baseline to 3 months
Secondary	Macular Pigment Optical Density at 6 months		baseline to 6 months
Secondary	Macular Pigment Optical Density at 12 months		baseline to 12 months