NCT00965237

Brief Summary

The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 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

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 14, 2011

Completed
Last Updated

July 10, 2012

Status Verified

January 1, 2012

Enrollment Period

4 months

First QC Date

August 24, 2009

Results QC Date

January 21, 2011

Last Update Submit

June 26, 2012

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

  • Overall Satisfaction With the Lenses

    Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.

    1 week of wear

Study Arms (2)

Multifocal CL / Single vision CL + reading glasses

OTHER

Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.

Device: lotrafilcon B multifocal contact lensDevice: lotrafilcon B single vision contact lensOther: Over-reader spectacles

Single vision CL + reading glasses / Multifocal CL

OTHER

Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.

Device: lotrafilcon B multifocal contact lensDevice: lotrafilcon B single vision contact lensOther: Over-reader spectacles

Interventions

lotrafilcon B multifocal contact lensDEVICE

Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use

Multifocal CL / Single vision CL + reading glassesSingle vision CL + reading glasses / Multifocal CL
lotrafilcon B single vision contact lensDEVICE

Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use

Multifocal CL / Single vision CL + reading glassesSingle vision CL + reading glasses / Multifocal CL
Over-reader spectaclesOTHER

Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis

Multifocal CL / Single vision CL + reading glassesSingle vision CL + reading glasses / Multifocal CL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • has discontinued contact lens wear primarily due to age-related, near vision demands
  • requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction
  • has had an ocular examination in the last 2 years

You may not qualify if:

  • has any ocular disease
  • has more than a 2.00D prescription difference between eyes
  • cannot be fit successfully with the study contact lenses
  • has any systemic disease affecting ocular health
  • is using any systemic or topical medications that may affect ocular health
  • has undergone corneal refractive surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs
Organization
CIBA VISION
priya.janakiraman@cibavision.com
1-800-241-7629

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 10, 2012

Results First Posted

March 14, 2011

Record last verified: 2012-01

Locations

CA(1)