Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status

Completed

Conditions

Visual Acuity

Treatments

Device: etafilcon A Test 2
Other: Control
Device: etafilcon A Test 3
Device: etafilcon a Test 1

Study type

Interventional

Funder types

Industry

Identifiers

NCT03782571
CR-6291

Details and patient eligibility

About

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.

Enrollment

34 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

34 participants in 4 patient groups

Test1/Test2/Control/Test3
Experimental group
Description:
Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
Treatment:
Device: etafilcon a Test 1
Device: etafilcon A Test 3
Other: Control
Device: etafilcon A Test 2
Test2/Test3/Test1/Control
Experimental group
Description:
Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
Treatment:
Device: etafilcon a Test 1
Device: etafilcon A Test 3
Other: Control
Device: etafilcon A Test 2
Test3/Control/Test2/Test1
Experimental group
Description:
Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
Treatment:
Device: etafilcon a Test 1
Device: etafilcon A Test 3
Other: Control
Device: etafilcon A Test 2
Control/Test1/Test3/Test2
Experimental group
Description:
Subjects that are adapted soft contact lens wearers between the ages of 18-40 years of age will be randomly assigned to one of four sequences. Upon completion, each subject will have worn all three lens types and been assigned the bare eye condition in both eyes.
Treatment:
Device: etafilcon a Test 1
Device: etafilcon A Test 3
Other: Control
Device: etafilcon A Test 2

Trial documents
1

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems