Evaluation of Dryness in a Silicone Hydrogel Daily Disposable Contact Lens
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ARM 1 Eligible subjects will be randomized to the TEST lens to wear in both eyes for approximately 2 weeks. |
Device: ACUVUE Oasys 1-Day
TEST
|
| Experimental: ARM 2 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
TEST
Device: Habitual Lens
Subjects' own Habitual Lenses
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change in CLUE Comfort [At 2-week follow-up]
Subjective overall vision and comfort scores will be assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers. A higher CLUE score indicates better comfort with respect to contact lens wear. The change is calculated as 2-week minus Baseline. The average change in CLUE Comfort for each arm will be reported.
Secondary Outcome Measures
- Change in CLDEQ-8 [At 2-week follow-up]
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 points 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. A 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 average change in CLDEQ-8 for each arm will be reported.
- CLEDQ-8 Total Score [At 2-week follow-up]
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 points 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. A higher CLDEQ-8 score indicates more dry eye symptoms with respect to contact lens wear. The average CLDEQ-8 for each arm will be reported.
- CLUE Comfort Score [At 2-week follow-up]
Subjective overall vision and comfort scores will be assessed using Contact Lens User Experience (CLUE) questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for population of soft disposable contact lens wearers. A higher CLUE score indicates better comfort with respect to contact lens wear. The average CLUE Comfort for each arm will be reported.
Eligibility Criteria
Criteria
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.
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Appear able and willing to adhere to the instructions set forth in this clinical protocol.
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Between 18 and 59 (inclusive) years of age at the time of screening.
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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.
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Have a CLDEQ-8 score of 15 or greater with the habitual lens.
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Subjects must possess a pair of spectacles for distance correction.
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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.
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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.
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The magnitude of subject's vertex corrected refractive cylinder must be less than 1.00 diopter in each eye.
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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:
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Subject's habitual lens is ACUVUE OASYS®1-Day.
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Currently pregnant or lactating, by self-report.
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Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).
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Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).
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Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.
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Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
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Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).
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Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal.
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. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
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Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.
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Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).
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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).
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
| 5 | Sacco Eye Group | Vestal | New York | United States | 13850 |
| 6 | Procare Vision Centers | Granville | Ohio | United States | 43023 |
| 7 | Dr. David Ferris & Associates | Warwick | Rhode Island | United States | 02888 |
| 8 | Optometry Group Pllc | Memphis | Tennessee | United States | 38111 |
| 9 | Tyler Eye Associates | Tyler | Texas | United States | 75703 |
Sponsors and Collaborators
- Johnson & Johnson Vision Care, Inc.
Investigators
- Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial, Johnson & Johnson Vision Care, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR-6388