Clinical trial NCT04849780: Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Official title: Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-site, randomized, bilateral, dispensing, parallel design study with two arms to evaluate contact lens related dry eye symptoms and subjective comfort.


Eligibility criteria: Inclusion Criteria:

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

1. The subject must 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. Between 18 and 59 (inclusive) years of age at the time of screening.
4. Be a daily disposable current soft contact lens wearer in both eyes with a minimum of 6 days/week wear time over the last 1 month by self-report.
5. Have a CLDEQ-8 score of 15 or greater with the habitual lens.
6. Subjects must possess a pair of spectacles for distance correction.
7. Subject's habitual lens must be the following lens types: Alcon DAILIES® Aqua Comfort Plus® , Alcon DAILIES TOTAL1®, CooperVision® clariti® 1 day, CooperVision® MyDay®, or Johnson \& Johnson 1-Day ACUVUE® Moist.
8. The subject's vertex corrected spherical distance refraction must be in the range of -1.00 D to -6.00 D (inclusive) in each eye.
9. The magnitude of subject's vertex corrected refractive cylinder must be less than 1.00 diopter in each eye.

11. Have spherical 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. Subject's habitual lens is ACUVUE OASYS®1-Day.
2. Currently pregnant or lactating, by self-report.
3. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
4. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
5. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
8. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal.
9. . Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
10. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
11. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
12. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (Rx or over the counter (OTC)) that may interfere with contact lens wear (at the discretion of the investigator).
13. 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.
14. 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.

Primary outcomes:
measure: Change From Baseline Comfort Score
timeFrame: Up to 2-Week Follow-up
Secondary outcomes:
measure: Change From Baseline CLDEQ-8 Score
timeFrame: Up to 2-Week Follow-up
measure: Comfort Score
timeFrame: 2-Week Follow-up
measure: CLDEQ-8 Score
timeFrame: 2-Week Follow-up
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Vue Optical Boutique
state: Florida
city: Longwood
country: United States
facility: Sabal Eye Care
state: Florida
city: Maitland
country: United States
facility: Maitland Vision Center
state: Florida
city: Pittsburg
country: United States
facility: Kannarr Eye Care
state: Kansas
city: Vestal
country: United States
facility: Sacco Eye Group
state: New York
city: Granville
country: United States
facility: Procare Vision Centers
state: Ohio
city: Warwick
country: United States
facility: Dr. David Ferris & Associates
state: Rhode Island
city: Memphis
country: United States
facility: Optometry Group Pllc
state: Tennessee
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: