N/A
N=72
Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03024970 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Subjective Ratings on Comfort — 9.7; 9.6 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- stenfilcon A lens with solution additive (test) (Device); stenfilcon A lens (control) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Ratings on Comfort |
8.9; 8.6 | — |
| PRIMARY Subjective Ratings on Comfort |
8.9; 8.6 | — |
| PRIMARY Subjective Ratings on Comfort |
8.9; 8.6 | — |
| PRIMARY Vision Satisfaction |
3; 1; 1; 3; 4; 9 | — |
| PRIMARY Vision Satisfaction |
3; 1; 1; 3; 4; 9 | — |
| PRIMARY Vision Satisfaction |
3; 1; 1; 3; 4; 9 | — |
| PRIMARY Visual Acuity On High Illumination High Contrast |
-0.21; -0.20 | — |
| PRIMARY Visual Acuity On High Illumination High Contrast |
-0.21; -0.20 | — |
| PRIMARY Visual Acuity On High Illumination High Contrast |
-0.21; -0.20 | — |
| PRIMARY Visual Acuity On Low Illumination High Contrast |
-0.09; -0.09 | — |
| PRIMARY Visual Acuity On Low Illumination High Contrast |
-0.09; -0.09 | — |
| PRIMARY Visual Acuity On Low Illumination High Contrast |
-0.09; -0.09 | — |
| PRIMARY Overall Corneal Staining |
54; 58; 33; 30; 13; 11 | — |
| PRIMARY Overall Corneal Staining |
54; 58; 33; 30; 13; 11 | — |
| PRIMARY Conjunctival Staining |
0.42; 0.45 | — |
| PRIMARY Conjunctival Staining |
0.42; 0.45 | — |
| PRIMARY Bulbar Hyperemia |
1.36; 1.33 | — |
| PRIMARY Bulbar Hyperemia |
1.36; 1.33 | — |
| PRIMARY Limbal Hyperemia |
0.90; 0.78 | — |
| PRIMARY Limbal Hyperemia |
0.90; 0.78 | — |
| PRIMARY Palpebral Hyperemia |
1.02; 0.93 | — |
| PRIMARY Palpebral Hyperemia |
1.02; 0.93 | — |
| SECONDARY Lens Fit Acceptance |
3.3; 3.2 | — |
| SECONDARY Lens Fit Acceptance |
3.3; 3.2 | — |
| SECONDARY Lens Fit Acceptance |
3.3; 3.2 | — |
| SECONDARY Handling Satisfaction |
0; 1; 0; 4; 1; 0 | — |
| SECONDARY Handling Satisfaction |
0; 1; 0; 4; 1; 0 | — |
| SECONDARY Lens Surface - Wettability |
3.37; 3.38 | — |
| SECONDARY Lens Surface - Wettability |
3.37; 3.38 | — |
| SECONDARY Lens Surface - Wettability |
3.37; 3.38 | — |
| SECONDARY Lens Surface - Deposits |
0.06; 0.02 | — |
| SECONDARY Lens Surface - Deposits |
0.06; 0.02 | — |
| SECONDARY Lens Surface - Deposits |
0.06; 0.02 | — |
| SECONDARY Subjective Ratings on Dryness |
8.3; 8.1 | — |
| SECONDARY Subjective Ratings on Dryness |
8.3; 8.1 | — |
| SECONDARY Subjective Ratings on Dryness |
8.3; 8.1 | — |
Summary
The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).
Eligibility Criteria
Inclusion Criteria
- A person is eligible for inclusion in the study if he/she:
- Has had a self-reported oculo-visual examination in the last two years.
- Is at least 18 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Must achieve 20/30 or better (in each eye) with study lenses
- Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
- Has no more than 0.75 diopters of refractive astigmatism.
- Currently wears soft contact lenses.
- Have clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination
Exclusion Criteria
- A person will be excluded from the study if he/she:
- Has never worn contact lenses before.
- 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 (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
- Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT03024970). 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.