N/A
N=62
A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03235089 ↗Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Horizontal Lens Centration Assessed in Primary Gaze — -0.13; -0.04 millimeters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Lens (Device); Control Lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Horizontal Lens Centration Assessed in Primary Gaze |
-0.15; -0.06 | — |
| PRIMARY Horizontal Lens Centration Assessed in Primary Gaze |
-0.15; -0.06 | — |
| PRIMARY Vertical Lens Centration Assessed in Primary Gaze |
0.10; -0.03 | — |
| PRIMARY Vertical Lens Centration Assessed in Primary Gaze |
0.10; -0.03 | — |
| PRIMARY Lens Tightness Assessed by Push-up Test |
41; 49 | — |
| PRIMARY Lens Tightness Assessed by Push-up Test |
41; 49 | — |
| PRIMARY Primary Gaze Lag Assessed Observing Lens Movement in Graticule |
0.18; 0.12 | — |
| PRIMARY Primary Gaze Lag Assessed Observing Lens Movement in Graticule |
0.18; 0.12 | — |
| PRIMARY Horizontal Lens Lag Assessed Observing Lens Movement in Graticule |
3.0; 2.7 | — |
| PRIMARY Horizontal Lens Lag Assessed Observing Lens Movement in Graticule |
3.0; 2.7 | — |
| PRIMARY Overall Lens Fit Acceptance |
2.7; 3.0 | — |
| PRIMARY Overall Lens Fit Acceptance |
2.7; 3.0 | — |
| PRIMARY Up Gaze Lag Assessed Observing Lens Movement in Graticule |
0.34; 0.35 | — |
| PRIMARY Up Gaze Lag Assessed Observing Lens Movement in Graticule |
0.34; 0.35 | — |
| PRIMARY Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink |
0.43; 0.29 | — |
| PRIMARY Post-blink Movement Assessed by Amount of Lens Movement Immediately After the Blink |
0.43; 0.29 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT03235089). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.