We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dispensing Overnight Study in Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00349856
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : February 18, 2009
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Myopia Device: Biofinity Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dispensing Overnight Study in Lenses
Study Start Date : January 2005
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1 Device: Biofinity
Soft contact lens
Other Name: Purevision


Outcome Measures

Primary Outcome Measures :
  1. The primary objective of this trial is to assess safety of the investigational [ Time Frame: study visits, three monthly ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349856


Locations
Canada, Ontario
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada, N2L3G1
Sponsors and Collaborators
University of Waterloo
Cooper Companies
Investigators
Principal Investigator: Desmond Fonn, MOptom Centre for Contact Lens Research, University of Waterloo.
More Information

Responsible Party: Craig Woods, Research Manager, Centre for Contact Lens Research
ClinicalTrials.gov Identifier: NCT00349856     History of Changes
Other Study ID Numbers: P/209/04/O
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009