Dispensing Overnight Study in Lenses

NCT00349856 | Completed Phase 3

• 1 other identifier: P/209/04/O
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

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

  study visits, three monthly

Secondary Outcomes (1)

• 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

Study Arms (1)

1

ACTIVE COMPARATOR

Device: Biofinity

Interventions

Biofinity DEVICE

Soft contact lens

Also known as: Purevision

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Waterloo: lead
• Cooper Companies: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Desmond Fonn, MOptom

  Centre for Contact Lens Research, University of Waterloo.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: January 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

CA (1)