A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- Coopervision, Inc.
- Enrollment
- 31
- Locations
- 1
- Primary Endpoint
- Lens Tightness Assessed by Push-up Test
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Lens Tightness Assessed by Push-up Test
Time Frame: 6-hours
Lens Tightness was assessed by Push-up test 1% steps: (0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement)
Primary Gaze Lag Assessed Observing Lens Movement in Graticule
Time Frame: 6 hours
Primary gaze lag was assessed observing lens movement in graticule (0.1mm steps)
Overall Lens Fit Acceptance
Time Frame: 6 hours
Overall lens fit acceptance based on lens fit alone (scale 0-4 in 0.25 steps: 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Vertical Lens Centration Assessed in Primary Gaze
Time Frame: 6-hours
Vertical Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-superior decentration given +ve value, inferior decentration given -ve value)
Horizontal Lens Lag Assessed Observing Lens Movement in Graticule
Time Frame: 6 hours
Horizontal lens lag was assessed observing lens movement in graticule (0.1mm steps)
Up Gaze Lag Assessed Observing Lens Movement in Graticule
Time Frame: 6 hours
Up gaze lag was assessed observing lens movement in graticule (0.1mm steps) (The amount of lens drop in mm that occurs when the eye moves from primary gaze to up gaze).
Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink
Time Frame: 6 hours
Post-blink Movement was assessed by amount of movement (to the nearest 0.1mm) immediately after the blink
Horizontal Lens Centration Assessed in Primary Gaze
Time Frame: 6-hour
Horizontal Lens Centration assessed in primary gaze was measured in 0.1mm steps. (mm-nasal decentration given +ve value, temporal decentration given -ve value)