Evaluation of the Performance of Non-molded Soft Contact Lenses

Ametropia Clinical Trial

Official title:

Evaluation of the Performance of Non-molded Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371787
• Other study ID #: P/240/06/CV
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2006
• Last updated: January 5, 2011
• Start date: August 2006
• Est. completion date: December 2007

Study information

• Verified date: January 2011
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties.

Description:

To evaluate the performance of the study soft lens for vision, comfort, physiology and lens surface properties in a group of participants who present with lens related changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Male or female, good health, age >17yrs, able to wear contact lenses as primary vision correction, able to see well and achieve good fit with study lens, has understood & signed consent form.

Exclusion Criteria:

• Has active ocular disease, uses topical eye medication, wears gas permeable/silicone hydrogel /overnight wear contact lenses, is a participant in another clinical study, is deemed unsuitable for soft contact lens wear.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ametropia

Intervention

Device:
• Soft contact lens
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	CIBA VISION

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Acuity	level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.	baseline	No
Primary	Visual Acuity	level of vision measured using high contrast acuity chart, higher (more positive)logMAR indicates worse vision.	9 month	No
Primary	Neovascularisation	length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.	baseline	No
Primary	Neovascularization	length of the blood vessels entering the superior cornea, higher number means longer blood vessel penetration.	9 month	No