Clinical trial NCT04968925: Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
Official title: Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-20
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses will be worn in a bilateral fashion for a period of approximately 1-week each.


Eligibility criteria: Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be between 18 and 40 (inclusive) years of age at the time of screening.
4. By self-report, habitually wear soft spherical contact lenses in both eyes in a daily disposable wear modality. Habitual wear is defined as a minimum of 8 hours of wear per day, for a minimum of 4 days per week during the past 4 weeks.
5. By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week.
6. The vertex-corrected best spherical distance refraction (rounded to nearest 0.25 D) must be between -1.00 and -4.00 DS (inclusive) in each eye.
7. The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less.
8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Be currently pregnant or breastfeeding
2. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
3. Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
4. Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
5. Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
6. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
7. Have a history of amblyopia or strabismus.
8. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months.
9. Have clinically significant (Grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
10. Have any ocular infection.

Primary outcomes:
measure: Overall Comfort (Phase I)
timeFrame: 1-Week Follow-up
measure: End of Day Comfort (Phase I)
timeFrame: 1-Week Follow-up
measure: End of Day Dryness (Phase I)
timeFrame: 1-Week Follow-up
measure: End of Day Comfort (Phase II)
timeFrame: 1-Week Follow-up
measure: End of Day Dryness (Phase II)
timeFrame: 1-Week Follow-up
measure: Overall Comfort (Phase II)
timeFrame: 1-Week Follow-up
Secondary outcomes:
measure: Comfort Throughout the Day (Phase II)
timeFrame: 1-Week Follow-up
measure: Comfort While Using Digital Devices (Phase II)
timeFrame: 1-Week Follow-up
measure: Dryness While Using Digital Devices (Phase II)
timeFrame: 1-Week Follow-up
measure: Lens Awareness Upon Insertion (Phase II)
timeFrame: 1-Minute Post lens fitting
measure: Comfort Upon Insertion (Phase II)
timeFrame: 1-Minute Post lens fitting
measure: Overall Ease of Handling (Phase II)
timeFrame: 1-Week Follow-up
measure: Ease of Insertion (Phase II)
timeFrame: 1-Week Follow-up
measure: Ease of Removal (Phase II)
timeFrame: 1-Week Follow-up
Other outcomes:
Locations:
city: Mission Viejo
country: United States
facility: James R. Dugue Optometry
state: California
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Orange Park
country: United States
facility: Flora Chen Poveda, OD, PA
state: Florida
city: Roswell
country: United States
facility: Visual Eyes, Inc
state: Georgia
city: Bloomington
country: United States
facility: VisionPoint Center
state: Illinois
city: Albuquerque
country: United States
facility: ABQ Eye Care
state: New Mexico
city: Granville
country: United States
facility: ProCare Vision Center
state: Ohio
city: Memphis
country: United States
facility: Optometry Group LLC
state: Tennessee
city: Houston
country: United States
facility: Gulf Coast Vision Center, Inc.
state: Texas
city: Tyler
country: United States
facility: Tyler Eye Associates
state: Texas
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: