Clinical trial NCT01952665: A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Official title: A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2013-09-30
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Detailed description: Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.

Eligibility criteria: Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study
* Has had a self-reported visual exam in the last two years
* Is an adapted soft CL wearer
* Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)
* Has less than 0.75D spectacle cylinder in each eye
* Is correctable to a visual acuity of 20/25 or better in both eyes
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Is willing to comply with the wear schedule (at least 40 hrs per week)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has never worn contact lenses before
* Currently wears rigid gas permeable contact lenses
* Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day)
* Has a contact lens prescription outside the range of - 1.00 to -9.00D
* Has a spectacle cylinder greater than -0.50D of cylinder in either eye
* Has best corrected spectacle distance vision worse then 20/25 in either eye
* Has any systemic disease affecting ocular health
* Is using any systemic or topical medications that will affect ocular health
* Has any ocular pathology or severe insufficiency of lacrimal secretion
* Has persistent, clinically significant corneal or conjunctival staining
* Has active neovascularization or any central corneal scars
* Is aphakic
* Is presbyopic
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study

Primary outcomes:
measure: Comfort at Insertion
timeFrame: Dispense
measure: Visual Quality
timeFrame: Dispense
measure: Average Daily Wearing Time
timeFrame: 2 weeks
measure: Comfortable Wearing Time
timeFrame: 2 weeks
measure: Comfort
timeFrame: 2 weeks
measure: Dryness
timeFrame: 2 weeks
measure: Handling
timeFrame: 2 weeks
measure: Vision Satisfaction
timeFrame: 2 weeks
measure: Eye Whiteness/Redness
timeFrame: 2 weeks
measure: Overall Sensation of Moistness
timeFrame: 2 weeks
measure: Overall Sensation of Smoothness
timeFrame: 2 weeks
measure: Overall Comfort Satisfaction
timeFrame: 2 weeks
measure: Overall Dryness Satisfaction
timeFrame: 2 weeks
measure: Overall Handling Satisfaction
timeFrame: 2 weeks
measure: Overall Vision Satisfaction
timeFrame: 2 weeks
measure: Overall Satisfaction
timeFrame: 2 weeks
measure: Lens Preference, Pair 1 Comfilcon A
timeFrame: 2 weeks
measure: Lens Preference, Pair 1 Lotrafilcon B
timeFrame: 2 weeks
measure: Comfortable Wearing Time
timeFrame: 4 weeks
measure: Average Daily Wearing Time
timeFrame: 4 weeks
measure: Rewetting Drops
timeFrame: 4 weeks
measure: Comfort
timeFrame: 4 weeks
measure: Dryness
timeFrame: 4 weeks
measure: Handling
timeFrame: 4 weeks
measure: Vision Satisfaction
timeFrame: 4 weeks
measure: Eye Whiteness/Redness
timeFrame: 4 weeks
measure: Overall Sensation of Moistness
timeFrame: 4 weeks
measure: Overall Sensation of Smoothness
timeFrame: 4 weeks
measure: Overall Comfort Satisfaction
timeFrame: 4 weeks
measure: Overall Dryness Satisfaction
timeFrame: 4 weeks
measure: Overall Handling Satisfaction
timeFrame: 4 weeks
measure: Overall Vision Satisfaction
timeFrame: 4 weeks
measure: Overall Satisfaction
timeFrame: 4 weeks
measure: Lens Preference
timeFrame: 4 weeks
measure: Lens Preference Comfort, Dryness, Vision and Overall.
timeFrame: 4 weeks
measure: Lens Preference for Handling
timeFrame: 4 weeks
Secondary outcomes:
measure: Binocular Visual Acuity logMAR
timeFrame: Dispense
measure: Surface Wetting
timeFrame: Dispense
measure: Surface Deposition
timeFrame: Dispense
measure: Centration
timeFrame: Dispense
measure: Corneal Coverage
timeFrame: Dispense
measure: Post Blink Movement
timeFrame: Dispense
measure: Push Up Test
timeFrame: Dispense
measure: Overall Fit Acceptance
timeFrame: Dispense
measure: Rewetting Drops
timeFrame: 2 weeks
measure: Binocular Visual Acuity logMAR
timeFrame: 2 Weeks
measure: Surface Wetting
timeFrame: 2 Weeks
measure: Surface Deposition
timeFrame: 2 Weeks
measure: Centration
timeFrame: 2 Weeks
measure: Corneal Coverage
timeFrame: 2 Weeks
measure: Post Blink Movement
timeFrame: 2 Weeks
measure: Push Up Test
timeFrame: 2 Weeks
measure: Overall Fit Acceptance
timeFrame: 2 Weeks
measure: Binocular Visual Acuity logMAR
timeFrame: 4 Weeks
measure: Surface Wetting
timeFrame: 4 Weeks
measure: Surface Deposition
timeFrame: 4 Weeks
measure: Centration
timeFrame: 4 Weeks
measure: Corneal Coverage
timeFrame: 4 Weeks
measure: Post Blink Movement
timeFrame: 4 Weeks
measure: Push Up Test
timeFrame: 4 Weeks
measure: Overall Fit Acceptance
timeFrame: 4 Weeks
measure: Likelihood of Switching From Habitual Lens to Study Lens
timeFrame: 4 weeks
measure: Likelihood to Continue Wearing the Study Lens
timeFrame: 4 weeks
measure: Participant Recommendation of a Study Lens
timeFrame: 4 weeks
measure: Participant Likelihood of Recommendation of a Study Lens
timeFrame: 4 weeks
Other outcomes:
measure: The Number of Trials Needed to Achieve Final Dispensing Pair of Study Lenses.
timeFrame: Dispense
Locations:
city: Campbell
country: United States
facility: Family Eye Care Center
state: California
city: Whittier
country: United States
facility: Golden Optometric Group
state: California
city: Athens
country: United States
facility: Drs. Quinn, Foster, &Associates
state: Georgia
city: Oak Lawn
country: United States
facility: Davis EyeCare Associates
state: Illinois
city: Pittsburg
country: United States
facility: Kannarr Eye Care LLC
state: Kansas
city: Medina
country: United States
facility: Complete Eye Care of Medina
state: Minnesota
Study officials:
affiliation: CooperVision, US
name: Donald Siegel, OD
role: PRINCIPAL_INVESTIGATOR
References: