Clinical trial NCT02500368: A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Official title: A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 41
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

Detailed description: The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table.

Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).

Eligibility criteria: Inclusion criteria:

-A person is eligible for inclusion in the study if he/she:

* Is at least 17 years of age and has full legal capacity to volunteer
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses
* Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

Exclusion Criteria:

-A person will be excluded from the study if he/she:

* Is participating in any concurrent clinical or research 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
* Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
* Is aphakic
* Has undergone corneal refractive 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. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)

For the purposes of this study, participants will be excluded\*\*, if currently taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

Primary outcomes:
measure: Comfort
timeFrame: Baseline and 1 week
measure: Dryness
timeFrame: Baseline and 1 week
Secondary outcomes:
measure: Lens Wettability
timeFrame: Baseline and 1 week
measure: Surface Appearance
timeFrame: Baseline
measure: Surface Appearance
timeFrame: 1 week
measure: High Contrast Acuity at High Room Illumination
timeFrame: Baseline and 1 week
measure: Lens Deposition
timeFrame: Baseline and 1 week
measure: Lens Problems
timeFrame: Baseline and 1 week
measure: Lens Centration
timeFrame: Baseline
measure: Lens Centration
timeFrame: 1 week
measure: Post-blink Movement
timeFrame: Baseline and 1 week
measure: Lens Tightness
timeFrame: Baseline and 1 week
measure: Visual Quality
timeFrame: Baseline and 1 week
measure: Ease of Lens Insertion
timeFrame: Baseline and 1 week
measure: Ease of Lens Removal
timeFrame: 1 week
measure: Overall Lens Fit
timeFrame: Baseline and 1 week
measure: Bulbar Hyperemia
timeFrame: Baseline and 1 week
measure: Limbal Hyperemia
timeFrame: Baseline and 1 week
measure: Corneal Dehydration Staining
timeFrame: 1 week
measure: Corneal Staining (Extent)
timeFrame: Baseline and 1 week
measure: Conjunctival Indentation
timeFrame: Baseline and 1 week.
measure: Conjunctival Staining
timeFrame: Baseline and 1 week
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: Center for Contact Lens Research, University of Waterloo
name: Lyndon Jones, PhD FCO
role: PRINCIPAL_INVESTIGATOR
References: