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Dispensing Overnight Study in Lenses

Primary Purpose

Myopia

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Biofinity
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Has had an oculo-visual examination in the last 2 years. Is between 18-45 years old and has full legal capacity to volunteer. Has read and understood the Information Consent Letter Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits. Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step). Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye. Is a current soft contact lens wearer (both daily wear and extended wear experience allowed). Has refractive astigmatism of <= 1.00 diopters Has clear corneas and ocular clinical findings considered to be "normal". Exclusion Criteria: Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities. Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant. Has never worn contact lenses before. Has corneal distortion resulting from rigid lens wear. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of clinical or research study.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

The primary objective of this trial is to assess safety of the investigational

Secondary Outcome Measures

The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.

Full Information

First Posted
July 5, 2006
Last Updated
February 17, 2009
Sponsor
University of Waterloo
Collaborators
Cooper Companies
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1. Study Identification

Unique Protocol Identification Number
NCT00349856
Brief Title
Dispensing Overnight Study in Lenses
Official Title
Dispensing Overnight Study in Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Waterloo
Collaborators
Cooper Companies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping.
Detailed Description
The purpose of the study is to evaluate the fit and performance of an investigational soft contact lens in comparison with a currently marketed lens. Both lenses will be worn on a continuous wear basis, which means the lenses will be worn while sleeping. Physiological changes will be monitored and subjective ratings collected.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Biofinity
Other Intervention Name(s)
Purevision
Intervention Description
Soft contact lens
Primary Outcome Measure Information:
Title
The primary objective of this trial is to assess safety of the investigational
Time Frame
study visits, three monthly
Secondary Outcome Measure Information:
Title
The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.
Time Frame
study visits, three monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Has had an oculo-visual examination in the last 2 years. Is between 18-45 years old and has full legal capacity to volunteer. Has read and understood the Information Consent Letter Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits. Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step). Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye. Is a current soft contact lens wearer (both daily wear and extended wear experience allowed). Has refractive astigmatism of <= 1.00 diopters Has clear corneas and ocular clinical findings considered to be "normal". Exclusion Criteria: Has any systemic disease affecting ocular health. Is using any systemic or topical medications that will affect ocular health. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities. Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant. Has never worn contact lenses before. Has corneal distortion resulting from rigid lens wear. Is aphakic. Has undergone corneal refractive surgery. Is participating in any other type of clinical or research study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Desmond Fonn, MOptom
Organizational Affiliation
Centre for Contact Lens Research, University of Waterloo.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L3G1
Country
Canada

12. IPD Sharing Statement

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Dispensing Overnight Study in Lenses

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