Evaluation of the Performance of Non-Moulded Soft Contact Lenses

This study has been completed.

First Received: September 1, 2006 Last Updated: February 13, 2009 History of Changes

Sponsors and Collaborators:	University of Waterloo Ciba Vision, Inc.
Information provided by:	University of Waterloo
ClinicalTrials.gov Identifier:	NCT00371787

Purpose

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

Condition	Intervention	Phase
Ametropia	Device: Soft contact lens	Phase III

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of the Performance of Non-Moulded Soft Contact Lenses

Further study details as provided by University of Waterloo:

Primary Outcome Measures:

The primary outcome measure is the efficacy of the soft lens over the 9 month study period [ Time Frame: Baseline, 2 weeks, 1 month, 3,6 and 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary outcome measures are the subjective and objective ocular responses to the soft lens and comparison to the previously worn lenses. [ Time Frame: as above ] [ Designated as safety issue: Yes ]

Enrollment:	30
Study Start Date:	August 2006
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Chronic lens wearers	Device: Soft contact lens Soft contact lens

Detailed 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.

Eligibility

Ages Eligible for Study:	17 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371787

Locations

Canada, Ontario
Centre for Contact Lens Research, University of Waterloo,
Waterloo, Ontario, Canada, N2L 3G1

Sponsors and Collaborators

University of Waterloo

Ciba Vision, Inc.

Investigators

Principal Investigator:

Desmond Fonn

Centre for Contact Lens Research

More Information

No publications provided

Responsible Party:	CCLR ( Craig Woods, Research Manager )
Study ID Numbers:	P/240/06/CV
Study First Received:	September 1, 2006
Last Updated:	February 13, 2009
ClinicalTrials.gov Identifier:	NCT00371787 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Eye Diseases
Refractive Errors

Additional relevant MeSH terms:

Eye Diseases
Refractive Errors

ClinicalTrials.gov processed this record on May 07, 2009