Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses

Not Applicable

Completed

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

Detailed 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 & Eligibility

Inclusion Criteria

Is at least 17 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Is a current wearer of soft contact lenses and has worn them (any brand) more than 3 months.
Is able to wear lenses for at least 12 hours a day.

Exclusion Criteria

Is participating in any concurrent clinical study;
Has any known active* ocular disease and/or infection;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
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.

Arm && Interventions

Group	Intervention	Description
delefilcon A	delefilcon A	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
stenfilcon A	delefilcon A	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
stenfilcon A	stenfilcon A	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).
delefilcon A	stenfilcon A	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).

Primary Outcome Measures

Name	Time	Method
Moisture Retention (Mean) of Stenfilcon A and Delefilcon A	12 Hours of Wear	Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Moisture Retention (Median) of Stenfilcon A and Delefilcon A	12 Hours of Wear	Comparison between lens types up to and at 12 hours of wear of moisture retention by measuring relative percentage dehydration (RPD).
Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A	12 Hours of Wear	Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).
Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A	12 Hours of Wear	Comparison between lens types up to and at 12 hours of wear for the absolute change in water content (WC).

Secondary Outcome Measures

Name	Time	Method
Subjective Comfort of Stenfilcon A and Delefilcon A	Up to 12 Hours of Wear	Subjective ratings for stenfilcon A and delefilcon A assessed at every hour up to 12 hours. (Scale 0-100, 0=very poor 100=excellent)