N/A
N=65
Ocular Characteristics in Contact Lens and Spectacle Wear
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT03913377 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT) — 8.28; 11.10 Seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spectacles (Device); ACUVUE OASYS®1-Day with HydraLuxe™ Technology (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-Invasive Break Up Time (NIBUT) or Non-Invasive Keratograph Break Up Time (NIKBUT) |
8.28; 11.10 | — |
| SECONDARY Total Scores of Meibomian Gland Expressibility (MGE) |
8.5; 8.5 | — |
| SECONDARY Conjunctival Staining |
41; 59; 34; 23; 7; 0 | — |
| SECONDARY Number of Eyes With Clinically Significant (Grade 3 or 4 of Overall Classification) Lid Wiper Epitheliopathy |
36; 31; 15; 19; 29; 30 | — |
| SECONDARY Meibomian Gland Expressibility (MGE) Grades |
0; 0; 0; 0; 10; 6 | — |
Summary
This clinical study will investigate the difference in ocular characteristics between contact lens wear and spectacle wear among habitual contact lens wearers, using a 2-treatment by 2-period cross-over design. There will be a 1-week washout between the two study periods to eliminate any potential carryover effect.
Eligibility Criteria
Inclusion Criteria
- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- The subject will have completed the pre-screening Classification questionnaire.
- Subject must have a working cell phone capable of sending and receiving text messages.
- 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 42 (inclusive) years of age at the time of screening
- Be a current soft contact lens wearer in both eyes with a minimum of 5 days/week wear time over the last 1 month by self-report OR be a full-time spectacle wearer (7 days/ week) without contact lens wear over the last 6 months.
- Subjects must be willing to adhere to spectacle-only refractive correction for approximately 1 week.
- Subjects must possess a functional / usable pair of spectacles with which they can achieve 20/20 Snellen visual acuity or better at distance and near, and bring them to the visit
- The subject's vertex corrected spherical distance refraction must be in the range (+/-0.25 D) of -2.00 D to -6.00 D (inclusive) in each eye.
- The subject's vertex corrected refractive cylinder must be equal or less than -0.75 diopters in each eye.
- Contact lens wearers must have spherical best corrected visual acuity of 20/25 or better in each eye.
- Snellen visual acuity at distance and near must be within 1 line between subject's own spectacle and the manifest refraction, distance and near, OD & OS.
Exclusion Criteria
- 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 and/or participation in the study (at the discretion of the investigator).
- Any active ocular abnormalities/conditions that may interfere with contact lens wear and/or participation in the study (at the discretion of the investigator).
- 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
- Habitual spectacle contains an add power, photochromic or tint.
- 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 and/or participation in the study (at the discretion of the investigator)
- Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- Any Grade 3 or greater biomicroscopy findings (this includes, corneal edema, corneal staining, corneal vascularization, conjunctival injection, tarsal abnormalities, bulbar injection) on the FDA classification scale (CTP-2018).
- Accommodative/binocular dysfunction, determined by study procedures.
Data sourced from ClinicalTrials.gov (NCT03913377). 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.