Clinical trial NCT03235089: A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Official title: A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2017-08-01
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a non-dispensing, double-masked, contralateral study comparing test contact lens against a nelfilcon A control lens. Subjects will be randomized to wear the test lens in one eye and the control lens in the other. It is anticipated that this study will involve up to 2 scheduled visits, at Baseline (BL) and 6 hours.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

Detailed description: The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Eligibility criteria: Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer
* Has read, fully understood and signed the information consent letter
* Currently wears or has previously worn soft contact lenses
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
* Has clear corneas and no active ocular disease
* Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion Criteria:

* Has never worn contact lenses before
* 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 any known active ocular disease and/or infection
* Has a monovision correction
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
* Is aphakic
* Has undergone corneal refractive surgery
* Is pregnant or lactating, determined by self-report

Primary outcomes:
measure: Horizontal Lens Centration Assessed in Primary Gaze
timeFrame: Baseline
measure: Horizontal Lens Centration Assessed in Primary Gaze
timeFrame: 6-hour
measure: Vertical Lens Centration Assessed in Primary Gaze
timeFrame: Baseline
measure: Vertical Lens Centration Assessed in Primary Gaze
timeFrame: 6-hours
measure: Lens Tightness Assessed by Push-up Test
timeFrame: Baseline
measure: Lens Tightness Assessed by Push-up Test
timeFrame: 6-hours
measure: Primary Gaze Lag Assessed Observing Lens Movement in Graticule
timeFrame: Baseline
measure: Primary Gaze Lag Assessed Observing Lens Movement in Graticule
timeFrame: 6 hours
measure: Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
timeFrame: Baseline
measure: Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
timeFrame: 6 hours
measure: Overall Lens Fit Acceptance
timeFrame: Baseline
measure: Overall Lens Fit Acceptance
timeFrame: 6 hours
measure: Up Gaze Lag Assessed Observing Lens Movement in Graticule
timeFrame: Baseline
measure: Up Gaze Lag Assessed Observing Lens Movement in Graticule
timeFrame: 6 hours
measure: Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
timeFrame: Baseline
measure: Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
state: Indiana
Study officials:
References: