NCT01444313

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

June 19, 2018

Status Verified

October 1, 2014

Enrollment Period

2.2 years

First QC Date

August 30, 2011

Last Update Submit

June 18, 2018

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (2)

  • Macular Pigment Optical Density at 9 months

    baseline to 9 months

  • Macular Pigment Optical Density at 15 months

    baseline to 15 months

Secondary Outcomes (3)

  • Macular Pigment Optical Density at 3 months

    baseline to 3 months

  • Macular Pigment Optical Density at 6 months

    baseline to 6 months

  • Macular Pigment Optical Density at 12 months

    baseline to 12 months

Study Arms (2)

nelfilcon A OD / narafilcon A OS

OTHER

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).

Device: narafilcon A contact lensDevice: nelfilcon A soft contact lenses

narafilcon A OD / nelfilcon A OS

OTHER

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).

Device: narafilcon A contact lensDevice: nelfilcon A soft contact lenses

Interventions

narafilcon A contact lensDEVICE

Soft contact lenses with UV protection

narafilcon A OD / nelfilcon A OSnelfilcon A OD / narafilcon A OS
nelfilcon A soft contact lensesDEVICE

Soft contact lenses without UV protection

narafilcon A OD / nelfilcon A OSnelfilcon A OD / narafilcon A OS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Birmingham, West Midlands, B4 7ET, United Kingdom

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 30, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2013

Last Updated

June 19, 2018

Record last verified: 2014-10

Locations

GB(1)