Status:
COMPLETED
Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief 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 hav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 25 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03782571
Start Date
November 16 2018
End Date
March 25 2019
Last Update
May 12 2020
Active Locations (1)
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1
The University of Manchester
Manchester, United Kingdom, M13 9PL