Dispensing Overnight Study in Lenses

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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Biofinity

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L3G1
      • Centre for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Has had an oculo-visual examination in the last 2 years.
2. Is between 18-45 years old and has full legal capacity to volunteer.
3. Has read and understood the Information Consent Letter
4. Is willing and able to follow participant instructions for product usage and meet the protocol-specified schedule of follow-up visits.
5. Is correctable with the prescription of the available lenses (-1.00 to -4.00 DS in 0.50D step).
6. Is correctable to at least 20/40 distance visual acuity with contact lenses in each eye.
7. Is a current soft contact lens wearer (both daily wear and extended wear experience allowed).
8. Has refractive astigmatism of <= 1.00 diopters
9. Has clear corneas and ocular clinical findings considered to be "normal".

Exclusion Criteria:

1. Has any systemic disease affecting ocular health.
2. Is using any systemic or topical medications that will affect ocular health.
3. Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities.
5. Has limbal injection, bulbar injection or corneal staining that, in the Investigator's opinion, is clinically significant.
6. Has never worn contact lenses before.
7. Has corneal distortion resulting from rigid lens wear.
8. Is aphakic.
9. Has undergone corneal refractive surgery.
10. Is participating in any other type of clinical or research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1	Device: Biofinity; Soft contact lens; Other Names: Purevision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary objective of this trial is to assess safety of the investigational	study visits, three monthly

Secondary Outcome Measures

Outcome Measure	Time Frame
The secondary objective of this trial is to assess the subjective responses to comfort with both the investigational and marketed lenses.	study visits, three monthly

Collaborators and Investigators

• Sponsor: University of Waterloo
• Collaborators: Cooper Companies
• Investigators: Principal Investigator: Desmond Fonn, MOptom, Centre for Contact Lens Research, University of Waterloo.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): March 1, 2008

Study Registration Dates

• First Submitted: July 5, 2006
• First Submitted That Met QC Criteria: July 5, 2006
• First Posted (Estimate): July 10, 2006

Study Record Updates

• Last Update Posted (Estimate): February 18, 2009
• Last Update Submitted That Met QC Criteria: February 17, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: P/209/04/O