Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

Myopia Clinical Trial

Official title:

Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02366923
• Other study ID #: EX-MKTG-56
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses.

Description:

The study will explore in vivo lens dehydration rates across a 12hr wear period for the study lenses. The primary outcome variable for this study is the loss in lens weight over the day, which will indicate the amount of dehydration that has occured.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

1. Is at least 17 years of age and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

3. Is willing and able to follow instructions and maintain the appointment schedule;

4. Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.

5. Is able to wear lenses for at least 12 hours a day.

Exclusion Criteria:

1. Is participating in any concurrent clinical study;

2. Has any known active* ocular disease and/or infection;

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Has undergone refractive error surgery;

• *For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Related Conditions & MeSH terms

• Dehydration
• Myopia

Intervention

Device:
• stenfilcon A
Each subject randomized to wear either the test or control in either the left of right eye.
• delefilcon A
Each subject randomized to wear either the test or control in either the left of right eye.

Locations

Country	Name	City	State
Canada	University of Waterloo School of Optometry	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A	Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).	12 Hours of Wear
Primary	Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A	Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).	12 Hours of Wear
Primary	Moisture Retention (Mean) of Stenfilcon A and Delefilcon A	Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).	12 Hours of Wear
Primary	Moisture Retention (Median) of Stenfilcon A and Delefilcon A	Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).	12 Hours of Wear
Secondary	Subjective Comfort of Stenfilcon A and Delefilcon A	Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)	Up to 12 Hours of Wear