Dispensing Overnight Study in Lenses

Myopia Clinical Trial

Official title:

Dispensing Overnight Study in Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349856
• Other study ID #: P/209/04/O
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2006
• Last updated: February 17, 2009
• Start date: January 2005
• Est. completion date: March 2008

Study information

• Verified date: February 2009
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Biofinity
Soft contact lens

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	Cooper Companies

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective of this trial is to assess safety of the investigational		study visits, three monthly	Yes
Secondary	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	Yes