Status:
COMPLETED
Clinical Characterization of Symptomatic Populations
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Ametropia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be w...
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.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Between 18 and 55 (inclusive) years of age at the time of screening.
- Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week wear time over the last 1 month by self-report.
- Have a baseline CLDEQ-8 score of either:
- 7 or lower
- 15 or greater
- Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).
- Subjects must pass a pre-screening questionnaire.
- Subjects must be willing to discontinue all contact lens wear for approximately 1 week/
- Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.
Exclusion
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Currently pregnant or lactating, by self-report.
- Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
- Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
- Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal
- 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 2 weeks prior to study enrollment.
- Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
- Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2018
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03319212
Start Date
September 29 2017
End Date
August 15 2018
Last Update
October 15 2019
Active Locations (2)
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1
VRC-East
Jacksonville, Florida, United States, 32256
2
University of Waterloo Center for Contact Lens Research
Waterloo, Ontario, Canada