Status:
COMPLETED
Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing clinical study. In Part 1 (Visits 1-4) all subjects will be Test Lens 1, in Part 2 (Visits 1-4) eligible subjects will be...
Eligibility Criteria
Inclusion
- Potential subjects must satisfy all of the criteria listed to be enrolled in the study.
- They are 18-45 years of age (inclusive).
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research while enrolled on this study.
- They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal.
- They agree to wear their lenses for at least 12-14 hours per day.
- They own a wearable pair of spectacles (by self-report).
- They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction).
- They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
- They have best corrected distance visual acuity of at least 0.20 binocularly
Exclusion
- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- They have an ocular disorder which would normally contraindicate contact lens wear.
- They have a systemic disorder which would normally contraindicate contact lens wear.
- No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses.
- They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week).
- They have had cataract surgery.
- They have had corneal refractive surgery.
- They are pregnant or breast-feeding.
- They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions.
- They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician).
- They have taken part in any other clinical trial or research within two weeks prior to starting this study.
- History of allergy to sodium fluorescein or lissamine green.
- They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus.
- They any slit lamp findings of Efron Grade 3 or greater (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 :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2022
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT03871543
Start Date
April 1 2019
End Date
February 3 2022
Last Update
May 16 2023
Active Locations (1)
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1
The University of Manchester - Eurolens Research
Manchester, United Kingdom