Status:
COMPLETED
Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Lead Sponsor:
Johnson & Johnson Vision Care, Inc.
Conditions:
Visual Acuity
Eligibility:
All Genders
18-59 years
Phase:
NA
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
- \- Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- 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 59 (inclusive) years of age at the time of screening.
- 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.
- Have a CLDEQ-8 score of 15 or greater with the habitual lens.
- Subjects must possess a pair of spectacles for distance correction.
- 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.
- 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.
- 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
- \- Potential subjects who meet any of the following criteria will be excluded from participating in the study:
- Subject's habitual lens is ACUVUE OASYS®1-Day.
- Currently pregnant or lactating, by self-report.
- Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
- Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
- Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
- 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.
- . 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 over the counter (OTC)) that may interfere with contact lens wear (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.
Key Trial Info
Start Date :
April 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04849780
Start Date
April 17 2021
End Date
August 12 2021
Last Update
October 10 2022
Active Locations (9)
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1
Vue Optical Boutique
Jacksonville, Florida, United States, 32205
2
Sabal Eye Care
Longwood, Florida, United States, 32792
3
Maitland Vision Center
Maitland, Florida, United States, 32751
4
Kannarr Eye Care
Pittsburg, Kansas, United States, 66762