A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Coopervision, Inc.
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Comfort
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 17 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
silicone hydrogel lens (test)
Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.
Intervention: silicone hydrogel lens (test) (Device)
enfilcon A lens (control)
Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.
Intervention: enfilcon A lens (control) (Device)
Outcomes
Primary Outcomes
Comfort
Time Frame: Baseline and 1 week
Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Dryness
Time Frame: Baseline and 1 week
Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.
Secondary Outcomes
- Lens Wettability(Baseline and 1 week)
- Lens Tightness(Baseline and 1 week)
- Ease of Lens Removal(1 week)
- Overall Lens Fit(Baseline and 1 week)
- Lens Problems(Baseline and 1 week)
- Post-blink Movement(Baseline and 1 week)
- Bulbar Hyperemia(Baseline and 1 week)
- Visual Quality(Baseline and 1 week)
- Corneal Dehydration Staining(1 week)
- Lens Deposition(Baseline and 1 week)
- Lens Centration(1 week)
- Ease of Lens Insertion(Baseline and 1 week)
- Corneal Staining (Extent)(Baseline and 1 week)
- Conjunctival Indentation(Baseline and 1 week.)
- Conjunctival Staining(Baseline and 1 week)
- Surface Appearance(1 week)
- High Contrast Acuity at High Room Illumination(Baseline and 1 week)
- Limbal Hyperemia(Baseline and 1 week)
- Surface Appearance(Baseline)
- Lens Centration(Baseline)