Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers

Study Overview
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Brief Summary
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This is a 2-Part, 8-Visit, single-center, open-label, bilateral and dispensing clinical study. In Part 1 (Visits 1-4) all subjects will be Test Lens 1, in Part 2 (Visits 1-4) eligible subjects will be dispensed Test Lens 2 based on their responses to the CLDEQ-8 questionnaire. Subjects scoring between 11 and 19 on the CLDEQ will not continue into Part 2

Official Title
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Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers

Conditions
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Visual Acuity

Intervention / Treatment
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* Device: AquaComfort Plus
* Device: Acuvue Oasys 1-Day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potential subjects must satisfy all of the criteria listed to be enrolled in the study. They are 18-45 years of age (inclusive). They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They agree not to participate in other clinical research while enrolled on this study. They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal. They agree to wear their lenses for at least 12-14 hours per day. They own a wearable pair of spectacles (by self-report). They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction). They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction). They have best corrected distance visual acuity of at least 0.20 binocularly Exclusion Criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: They have an ocular disorder which would normally contraindicate contact lens wear. They have a systemic disorder which would normally contraindicate contact lens wear. No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses. They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week). They have had cataract surgery. They have had corneal refractive surgery. They are pregnant or breast-feeding. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions. They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician). They have taken part in any other clinical trial or research within two weeks prior to starting this study. History of allergy to sodium fluorescein or lissamine green. They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus. They any slit lamp findings of Efron Grade 3 or greater (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of < Grade 3 which in the investigator's opinion would contraindicate contact lens wear.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Part 1<br>All eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1 | Device: AquaComfort Plus<br>* Test Lens 1<br>|
| Other: Part 2<br>All eligible subjects (based on CLDEQ responses) enrolled into Part 2 will be fit and dispensed with Test Lens 2 and will follow the same procedures as Part 1. | Device: Acuvue Oasys 1-Day<br>* Test Lens 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) | Lid margin staining of the upper and lower eyelids was performed in the left eye (OS) only using lissamine green. The following attributes were graded subjectively for each eyelid: Horizontal length of staining (Grade 0: < 2mm, Grade 1: 2-4 mm, Grade 2: 5-9 mm, Grade 3: >9 mm), and Sagittal width of staining relative to width of wiper (Grade 0: <25%, Grade 1: 25-50 %, Grade 2: 51-75%, Grade 3: >75%). The Average staining grade for each eyelid was also calculated which is the average of the horizontal and sagittal grades. Higher Lid Margin Staining values indicate that more staining was observed. | 14 Hours Follow-up at Visit 4 | 
| Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) | NIBUT was measured in timed seconds using the Medmont topographer for the right eye (OD) only. NIBUT values are positive, where higher NIBUT times (seconds) indicate a more stable tear film. | 14 Hours Follow-up at Visit 4 | 
| Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) | The lower tear meniscus in the right eye (OD) only was imaged and measured in mm using optical coherence tomography (OCT). Lower TMH values indicate reduced tear quantity. | 14 Hours Follow-up at Visit-4 | 
| Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) | Tear film osmolarity were collected and measured in (mOsms/L) in the right eye (OD) only using the Tearlab (Tearlab Corp.).Higher tear osmolarity values may be associated with ocular dryness. Participants were classified as symptomatic or asymptomatic based on their subjective questionnaire responses for the CLDEQ-8 questionnaire assessed after two weeks of lens wear (Visit 2). CLDEQ-8 is a validated patient-reported outcome measure assessing patient-experience of symptoms relating to contact lens dryness. | 14 Hours Follow-up at Visit 4 | 
| Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus) | Images, using Confocal Microscopy were taken in both eyes for both the upper and lower eyelid in the central lid area. These images were used to determine the mean density of inflammatory white blood cells. Higher white blood cell counts may be associated with an increased inflammatory response. The number of white blood cells is a count of the number of cells 'per frame'. A frame has a fixed area of 400 x 400 microns. The average number of White Blood Cells was reported for each group. | 2-Week Follow-up (after 6 hours lens wear) at Visit 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus). | VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 4 | 
| Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus). | VAS, and TMH 14 Hours Follow-up at Visit 4 | 
| Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus). | VAS, and Lid Margin staining 14 Hours Follow-up at Visit 4 | 
| Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4, (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus). | VAS, and NIBUT 14 Hours Follow-up at Visit 4 | 
| Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus). | VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2 | 
| Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 4 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 2 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 4 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 3. Visit 3 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 2 (2-week after Visit 1). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 1 (Dailies Aqua Comfort Plus). | VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2 | 
| Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day). | VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 8 | 
| Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day). | VAS, and TMH 14 Hours Follow-up at Visit 8 | 
| Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 2. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day). | VAS, and LMS 14 Hours Follow-up at Visit 8 | 
| Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day). | VAS, and LMS 14 Hours Follow-up at Visit 8 | 
| Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8 (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day). | VAS, and WBC before lens removal at Visit 6 | 
| Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day) | Clinical measures (LMS, NIBUT, TMH, tear film osmolarity) were assessed at Visit 8, (14 Hours Follow-up), while density of white blood cells were assessed at Visit 6 (2 week follow-up). Clinical Measures, LMS, NIBUT, TMH and Tear Film Osmolarity were measured in the right (OD) eye only, while white blood cells were assessed in both eyes for both the upper and lower eye lids. End of the day comfort was assessed at Visit 8 for Clinical measures (LMS, NIBUT, TMH, tear film osmolarity), approximately 14 Hours after lens insertion at Visit 7. Visit 7 could occur between two to 180 days after Visit 6. End of Day Comfort for white blood cells was assessed at Visit 6 (2-week after Visit 5). End of the day comfort was assessed using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable. The average end of the day comfort score was reported for the Test 2 (Acuvue Oasys 1-Day). | VAS, and WBC before lens removal at Visit 6 |