Clinical trial NCT03782571: Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
Official title: Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between 18 and 40 (inclusive) years of age at the time of screening.
  4. The subject must own a wearable pair of spectacles and be willing to wear them to each study visit.
  5. 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.
  6. The subject must agree not to participate in other clinical research for the duration of this study.
  7. The subject's refractive cylinder must be \<-1.25DC in each eye.
  8. 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:

  1. Currently pregnant or breast feeding (self-reported).
  2. 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).
  3. Use of topical medication such as eye drops or ointment within 24 hours prior to the study visit.
  4. Any history of anaphylaxis or severe allergy.
  5. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  6. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
  7. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  8. 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.

Primary outcomes:
measure: Microsphere Clearance Rate
timeFrame: Post microsphere application over a 30 minute period
measure: Microsphere Uptake Rate
timeFrame: Post microsphere application over a 10 minute period
Secondary outcomes:
measure: Lens Movement
timeFrame: Post microsphere application at 30-minute timepoint (OD); post microsphere application at 10-minute timepoint (OS)
measure: Corneal Curvature
timeFrame: Baseline
measure: Corneal Curvature
timeFrame: Baseline
measure: Blink Rate
timeFrame: Baseline and the 30-minute post microsphere application time point in the right eye and at the 10-minute post microsphere application timepoint in the left eye.
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
Study officials:
References: