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

• ClinicalTrials.gov Identifier: NCT03871543
• Recruitment Status: Completed
• First Posted: March 12, 2019
• Last Update Posted: February 23, 2022
• Sponsor: Johnson & Johnson Vision Care, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Vision Care, Inc.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Visual Acuity	Device: AquaComfort Plus; Device: Acuvue Oasys 1-Day	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 196 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Late Night Study 2: End-of-Day Assessment of Asymptomatic and Symptomatic Soft Lens Wearers
• Actual Study Start Date: April 1, 2019
• Actual Primary Completion Date: February 3, 2022
• Actual Study Completion Date: February 3, 2022

Arms and Interventions

Arm	Intervention/treatment
Part 1; All eligible subjects enrolled into Part 1 will be fit and dispensed with Test Lens 1	Device: AquaComfort Plus; Test Lens 1
Part 2; 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; Test Lens 2

Outcome Measures

Primary Outcome Measures :

1. Subjective Grade of Lid Margin Staining [ Time Frame: Approximately 14 hours of contact lens wear ]
   Lid margin staining of the upper and lower eyelids will be performed in the left eye (OS) only using lissamine green. The following will be graded subjectively for each eyelid: Horizontal length of staining, Sagittal width of staining, and Average staining grade - this is the average of the horizontal and sagittal grades for each eyelid. A final grade will be calculated which is the average of each eyelid's average staining grade.
2. Objective Grade of Lid Margin Staining [ Time Frame: Approximately 14 hours of contact lens wear ]
   Lid margin staining of the upper and lower eyelids will be performed in the left eye (OS) only using lissamine green. For the objective image analysis three metrics of staining will be evaluated; (1) Staining Area, (2) Staining Intensity and (3) Staining thickness.
3. Non-invasive Break-up Time (NIBUT) [ Time Frame: Approximately 14 hours of contact lens wear ]
   NIBUT will be measured in timed seconds using the Medmont topographer for the right eye (OD) only.
4. Tear Meniscus Height [ Time Frame: Approximately 14 hours of contact lens wear ]
   The lower tear meniscus in the right eye (OD) only will be imaged and measured in mm using optical coherence tomography (OCT).
5. Tear Film Osmolarity [ Time Frame: Approximately 14 hours of contact lens wear ]
   Tear film osmolarity will be collected and measured in (mOsms/L) in the right eye (OD) only using the Tearlab (Tearlab Corp.)
6. White Blood Cells [ Time Frame: Approximately 6 hours of contact lens wear ]
   Images, using Confocal Microscopy will be taken in both eyes for both the upper and lower eyelid in the central lid area. These images will be used to determine the mean density of inflammatory white blood cells.

Secondary Outcome Measures :

1. Beginning Day Comfort [ Time Frame: 5 minutes post lens insertion ]
   Contact lens comfort will be assessed at the beginning of day using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable.
2. End of Day Comfort [ Time Frame: Approximately 14 hours of contact lens wear ]
   Contact lens comfort will be assessed at the end of day using a visual analogue scale (VAS) ranging from 0 - 100, where 0 is uncomfortable and 100 is comfortable.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United Kingdom

The University of Manchester - Eurolens Research

Manchester, United Kingdom

Sponsors and Collaborators

Johnson & Johnson Vision Care, Inc.

Investigators

• Study Director: Johnson & Johnson Vision Care, Inc. Clinical Trial; Johnson & Johnson Vision Care, Inc.

More Information

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03871543
• Other Study ID Numbers: CR-6290
• First Posted: March 12, 2019
• Last Update Posted: February 23, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
• URL: http://yoda.yale.edu

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes