Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: ACUVUE Oasys 1-Day
* Device: Habitual Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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 Criteria: - 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM 1<br>Eligible subjects will be randomized to the TEST lens to wear in both eyes for approximately 2 weeks. | Device: ACUVUE Oasys 1-Day<br>* TEST<br>|
| Experimental: ARM 2<br>Eligible subjects will be randomized to the CONTROL lens to wear in both eyes for approximately 2 weeks. Then the subject will receive the TEST lens to wear in both eyes for approximately 2 weeks. | Device: ACUVUE Oasys 1-Day<br>* TEST<br>Device: Habitual Lens<br>* Subjects' own Habitual Lenses<br>* Other names: CONTROL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Comfort Score | Comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The change from baseline was calculated as 2-week follow-up minus baseline. The average change from baseline was reported for each arm. the change from baseline ranges from -120 to 120 where higher change from baseline comfort scores indicates a more favorable performance. | Up to 2-Week Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline CLDEQ-8 Score | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The change from baseline CLDEQ-8 score ranges from -30 to 30 where lower change from baseline CLDEQ-8 scores indicate better performance. The average change in CLDEQ-8 for each arm was reported. | Up to 2-Week Follow-up | 
| Comfort Score | Comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average comfort score was reported for each group within Arm 2 only. | 2-Week Follow-up | 
| CLDEQ-8 Score | The CLDEQ-8 is a validated outcome measure for soft contact lenses wearers. It has been highly correlated with habitual baseline status and change in overall opinion when subjects are refit with contact lenses. A CLDEQ-8 total score of ≥12 is proposed to identify contact lens wearers who could benefit from clinical management of their contact lens related symptoms. A three-point change in CLDEQ-8 total scores has also been shown to be clinically important. This study will include the symptomatic subjects who will have a CLDEQ total score of ≥15. CLDEQ-8 scores range from 0 to 30 where, higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm was reported. | 2-Week Follow-up |