Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: O1D/P1 Eligible subjects that are habitual wearers or daily disposable soft contact lenses will randomly be assigned sequence (O1D/P1) |
Device: ACUVUE Oasys 1-Day
TEST
Device: Precision 1
CONTROL
|
| Experimental: P1/O1D Eligible subjects that are habitual wearers or daily disposable soft contact lenses will randomly be assigned sequence (P1/O1D) |
Device: ACUVUE Oasys 1-Day
TEST
Device: Precision 1
CONTROL
|
Outcome Measures
Primary Outcome Measures
- Overall Comfort [1-week follow-up]
Overall comfort will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
- Comfort at The End of The Day [1-week follow-up]
Comfort at the end of the day will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
- Dryness at The End of The Day [1-week follow-up]
Dryness at the end of the day will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
Secondary Outcome Measures
- Comfort Throughout the Day [1-week follow-up]
Comfort throughout the day will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
- Comfort While Using Digital Devices [1-week follow-up]
Comfort while using digital devices will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
- Dryness While Using Digital Devices [1-week follow-up]
Dryness while using digital devices will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
- Lens Awareness Upon Insertion [approximately 15-minutes post lens insertion]
Lens awareness upon insertion will be assessed using individual questionnaire items and answered by subjects utilizing an Agreement response set (1: Strongly disagree, 2: Disagree, 3: Neither agree nor disagree, 4: Agree and 5: Strongly agree)
- Comfort Upon Insertion [approximately 15-minutes post lens insertion]
Comfort upon insertion will be assessed using individual questionnaire items and answered by subjects utilizing an Agreement response set (1: Strongly disagree, 2: Disagree, 3: Neither agree nor disagree, 4: Agree and 5: Strongly agree)
- Overall Ease of Handling [1-week follow-up]
Overall ease of handling will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
- Ease of Insertion [1-week follow-up]
Ease of insertion will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
- Ease of Removal [1-week follow-up]
Ease of removal will be assessed using individual questionnaire items and answered by subjects utilizing an Excellence response set (0: Not Applicable, 1: Excellent, 2: Very Good, 3: Good, 4: Fair and 5: Poor).
Eligibility Criteria
Criteria
Inclusion Criteria:
Potential subjects must satisfy all of the following criteria to be enrolled in the study:
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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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Be between 18 and 40 (inclusive) years of age at the time of screening.
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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.
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By self-report, typically uses computer screens and other digital devices (phones, tablets) at least 30 hours per week.
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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.
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The magnitude of the cylinder component of the subject's distance refraction must be 1.00 DC or less.
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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:
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Be currently pregnant or breastfeeding
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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.
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Have had any previous ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, cataract, etc.).
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Habitually wear monovision, multifocal, toric, or extended wear contact lens correction
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Have participated in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
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Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
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Have a history of amblyopia or strabismus.
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Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (eg, SynergEyes) within the past 6 months.
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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).
-
Have any ocular infection.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | James R. Dugue Optometry | Mission Viejo | California | United States | 92691 |
| 2 | Maitland Vision Center | Maitland | Florida | United States | 32751 |
| 3 | Flora Chen Poveda, OD, PA | Orange Park | Florida | United States | 32073 |
| 4 | Visual Eyes, Inc | Roswell | Georgia | United States | 30076 |
| 5 | VisionPoint Center | Bloomington | Illinois | United States | 61704 |
| 6 | ABQ Eye Care | Albuquerque | New Mexico | United States | 87109 |
| 7 | ProCare Vision Center | Granville | Ohio | United States | 43023 |
| 8 | Optometry Group LLC | Memphis | Tennessee | United States | 38111 |
| 9 | Gulf Coast Vision Center, Inc. | Houston | Texas | United States | 77054 |
| 10 | 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-6456