N/A
N=25
Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT03782571 ↗Enrolled (actual)
25
Serious AEs
1.0%
Results posted
May 2020
Primary outcome: Primary: Microsphere Clearance Rate — 96.9; 98.1; 99.4; 96.6 percent clearance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- etafilcon a Test 1 (Device); etafilcon A Test 2 (Device); etafilcon A Test 3 (Device); Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microsphere Clearance Rate |
96.9; 98.1; 99.4; 96.6 | — |
| PRIMARY Microsphere Uptake Rate |
8.5; 6.8; 2.9; 1.5 | — |
| SECONDARY Lens Movement |
0; 1; 2; 12; 7; 10 | — |
| SECONDARY Corneal Curvature |
3.700 | — |
| SECONDARY Corneal Curvature |
3.700 | — |
| SECONDARY Blink Rate |
0; 0; 0; 0; 28.2; 23.3 | — |
Summary
This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle correction having not worn contact lenses on the day of the visit.
Eligibility Criteria
Inclusion Criteria
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between 18 and 40 (inclusive) years of age at the time of screening.
- The subject must own a wearable pair of spectacles and be willing to wear them to each study visit.
- The subject must be an adapted soft contact lens wearer in both eyes, having successfully worn contact lenses in the last six months by self-report.
- The subject must agree not to participate in other clinical research for the duration of this study.
- The subject's refractive cylinder must be <-1.25DC in each eye.
- The subject must have best corrected visual acuity of 0.20 logMAR or better in each eye.
Exclusion Criteria
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or breast feeding (self-reported).
- Any systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the Investigator's discretion).
- Use of topical medication such as eye drops or ointment within 24 hours prior to the study visit.
- Any history of anaphylaxis or severe allergy.
- Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
- Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
- They have any slit lamp findings of grade 3 or higher (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of < Grade 3 which in the investigator's opinion would contraindicate contact lens wear.
Data sourced from ClinicalTrials.gov (NCT03782571). 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.