Clinical trial NCT02366923: Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Official title: Dehydration of Stenfilcon A Contact Lenses Versus Delefilcon A Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 28
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Absolute Change in Water Content (Mean) of Stenfilcon A and Delefilcon A
timeFrame: 12 Hours of Wear
measure: Absolute Change in Water Content (Median) of Stenfilcon A and Delefilcon A
timeFrame: 12 Hours of Wear
measure: Moisture Retention (Mean) of Stenfilcon A and Delefilcon A
timeFrame: 12 Hours of Wear
measure: Moisture Retention (Median) of Stenfilcon A and Delefilcon A
timeFrame: 12 Hours of Wear
Secondary outcomes:
measure: Subjective Comfort of Stenfilcon A and Delefilcon A
timeFrame: Up to 12 Hours of Wear
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: University of Waterloo School of Optometry
state: Ontario
Study officials:
affiliation: Director, Centre for Contact Lens Research
name: Lydon Jones, PhD FC
role: PRINCIPAL_INVESTIGATOR
affiliation: Univerisy of Waterloo
name: Farah Panjwani, BSc RAQ
role: PRINCIPAL_INVESTIGATOR
References: