N/A N=184 Treatment

Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers

Visual Acuity

Bottom Line

View on ClinicalTrials.gov: NCT03871543 ↗

Enrolled (actual)

184

Serious AEs

0.0%

Results posted

May 2023

Primary outcome: Primary: Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) — 1.02; 1.25; 1.45; 1.78 Units on a Scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AquaComfort Plus (Device); Acuvue Oasys 1-Day (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Johnson & Johnson Vision Care, Inc.
Primary completion: Feb 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)	1.02; 1.25; 1.45; 1.78	—
PRIMARY Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)	4.43; 4.32	—
PRIMARY Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)	0.20; 0.19	—
PRIMARY Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)	299.00; 301.89	—
PRIMARY Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus)	7.94; 14.91; 5.89; 12.19	—
SECONDARY Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)	76.24	0.3446
SECONDARY Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)	76.24	0.5556
SECONDARY Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)	76.24	0.1676
SECONDARY Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)	76.24	0.5483
SECONDARY Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus)	67.05	0.0719
SECONDARY Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus)	67.05	0.0190 sig
SECONDARY Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day)	85.28	0.0420 sig
SECONDARY Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day)	85.28	0.3973
SECONDARY Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day)	85.28	0.8894
SECONDARY Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day)	85.28	0.6129
SECONDARY Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day)	85.53	0.3493
SECONDARY Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day)	85.53	0.4270

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 dispensed Test Lens 2 based on their responses to the CLDEQ-8 questionnaire. Subjects scoring between 11 and 19 on the CLDEQ will not continue into Part 2

Eligibility Criteria

Inclusion Criteria

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 Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03871543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.