search
Back to results

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

Primary Purpose

Refractive Errors

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
narafilcon A contact lens
nelfilcon A soft contact lenses
Sponsored by
Johnson & Johnson Vision Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Refractive Errors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

nelfilcon A OD / narafilcon A OS

narafilcon A OD / nelfilcon A OS

Arm Description

Soft contact lens without UV protection worn on the right eye (OD) and soft contact lens with UV protection worn on the left eye (OS).

Soft contact lens with UV protection worn on the right eye (OD) and soft contact lens without UV protection worn on the left eye (OS).

Outcomes

Primary Outcome Measures

Macular Pigment Optical Density at 9 months
Macular Pigment Optical Density at 15 months

Secondary Outcome Measures

Macular Pigment Optical Density at 3 months
Macular Pigment Optical Density at 6 months
Macular Pigment Optical Density at 12 months

Full Information

First Posted
August 30, 2011
Last Updated
June 18, 2018
Sponsor
Johnson & Johnson Vision Care, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01444313
Brief Title
Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Official Title
Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Vision Care, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Errors

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
nelfilcon A OD / narafilcon A OS
Arm Type
Other
Arm Description
Soft contact lens without UV protection worn on the right eye (OD) and soft contact lens with UV protection worn on the left eye (OS).
Arm Title
narafilcon A OD / nelfilcon A OS
Arm Type
Other
Arm Description
Soft contact lens with UV protection worn on the right eye (OD) and soft contact lens without UV protection worn on the left eye (OS).
Intervention Type
Device
Intervention Name(s)
narafilcon A contact lens
Intervention Description
Soft contact lenses with UV protection
Intervention Type
Device
Intervention Name(s)
nelfilcon A soft contact lenses
Intervention Description
Soft contact lenses without UV protection
Primary Outcome Measure Information:
Title
Macular Pigment Optical Density at 9 months
Time Frame
baseline to 9 months
Title
Macular Pigment Optical Density at 15 months
Time Frame
baseline to 15 months
Secondary Outcome Measure Information:
Title
Macular Pigment Optical Density at 3 months
Time Frame
baseline to 3 months
Title
Macular Pigment Optical Density at 6 months
Time Frame
baseline to 6 months
Title
Macular Pigment Optical Density at 12 months
Time Frame
baseline to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 7ET
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs