Clinical trial NCT03871543: Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
Official title: Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Potential subjects must satisfy all of the criteria listed to be enrolled in the study.

  1. They are 18-45 years of age (inclusive).
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research while enrolled on this study.
  5. They currently use daily disposable soft daily wear contact lenses (worn bilaterally) (within the last six months) which may be spherical, toric or multifocal.
  6. They agree to wear their lenses for at least 12-14 hours per day.
  7. They own a wearable pair of spectacles (by self-report).
  8. They have a spherical contact lens prescription in the range +6.00 to -10.00 DS (based on the calculated ocular refraction).
  9. They have up to a maximum of 1.00 DC of refractive astigmatism (based on the calculated ocular refraction).
  10. 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:

  1. They have an ocular disorder which would normally contraindicate contact lens wear.
  2. They have a systemic disorder which would normally contraindicate contact lens wear.
  3. No ocular topical medications (including comfort drops) from 24 hours prior to study visits or during the wear of any study lenses.
  4. They are regularly using anti-inflammatory or pain medications (i.e. medication routinely used more than twice per week).
  5. They have had cataract surgery.
  6. They have had corneal refractive surgery.
  7. They are pregnant or breast-feeding.
  8. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV) or a history of anaphylaxis or severe allergic reactions.
  9. They are an employee or immediate family member of an employee of the clinical site (e.g. Investigator, Coordinator, Technician).
  10. They have taken part in any other clinical trial or research within two weeks prior to starting this study.
  11. History of allergy to sodium fluorescein or lissamine green.
  12. They have any corneal distortion e.g. as a result of previous rigid lens wear or have keratoconus.
  13. 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.

Primary outcomes:
measure: Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)
timeFrame: 14 Hours Follow-up at Visit 4
measure: Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)
timeFrame: 14 Hours Follow-up at Visit 4
measure: Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)
timeFrame: 14 Hours Follow-up at Visit-4
measure: Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)
timeFrame: 14 Hours Follow-up at Visit 4
measure: Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus)
timeFrame: 2-Week Follow-up (after 6 hours lens wear) at Visit 2
Secondary outcomes:
measure: Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus)
timeFrame: VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 4
measure: Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus)
timeFrame: VAS, and TMH 14 Hours Follow-up at Visit 4
measure: Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus)
timeFrame: VAS, and Lid Margin staining 14 Hours Follow-up at Visit 4
measure: Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus)
timeFrame: VAS, and NIBUT 14 Hours Follow-up at Visit 4
measure: Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus)
timeFrame: VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2
measure: Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus)
timeFrame: VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2
measure: Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day)
timeFrame: VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 8
measure: Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part2: Acuvue Oasys 1-Day)
timeFrame: VAS, and TMH 14 Hours Follow-up at Visit 8
measure: Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part2: Acuvue Oasys 1-Day)
timeFrame: VAS, and LMS 14 Hours Follow-up at Visit 8
measure: Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part2: Acuvue Oasys 1-Day)
timeFrame: VAS, and LMS 14 Hours Follow-up at Visit 8
measure: Relationship Between End of Day Comfort Scores and White Blood Cells Lower Lid (Part2: Acuvue Oasys 1-Day)
timeFrame: VAS, and WBC before lens removal at Visit 6
measure: Relationship Between End of Day Comfort Scores and White Blood Cells Upper Lid (Part2: Acuvue Oasys 1-Day)
timeFrame: VAS, and WBC before lens removal at Visit 6
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester - Eurolens Research
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: