NCT03871543

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

Completed NA Results posted Last updated 16 May 2023

What this trial tests

NA trial testing AquaComfort Plus in Visual Acuity in 196 participants. Completed in 3 February 2022.

Timeline

1 April 2019

Primary endpoint
3 February 2022

3 February 2022

Quick facts

Lead sponsor	Johnson & Johnson Vision Care, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	196
Start date	1 April 2019
Primary completion	3 February 2022
Estimated completion	3 February 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• AquaComfort Plus
• Acuvue Oasys 1-Day

Conditions studied

• Visual Acuity — all drugs for Visual Acuity →

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

Adults 18 to 45, any sex, with Visual Acuity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) Primary · 14 Hours Follow-up at Visit 4

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 obs

Upper Lid

Group	Value	95% CI
Asymptomatic	1.02	± 0.822
Symptomatic	1.25	± 0.943

Lower Lid

Group	Value	95% CI
Asymptomatic	1.45	± 0.896
Symptomatic	1.78	± 0.988

Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) Primary · 14 Hours Follow-up at Visit 4

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.

Group	Value	95% CI
Asymptomatic	4.43	± 3.386
Symptomatic	4.32	± 3.613

Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) Primary · 14 Hours Follow-up at Visit-4

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.

Group	Value	95% CI
Asymptomatic	0.20	± 0.058
Symptomatic	0.19	± 0.069

Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) Primary · 14 Hours Follow-up at Visit 4

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.

Group	Value	95% CI
Asymptomatic	299.00	± 12.098
Symptomatic	301.89	± 12.107

Number of White Blood Cells Per Frame in Eyelid Margin (Part1: Dailies Aqua Comfort Plus) Primary · 2-Week Follow-up (after 6 hours lens wear) at Visit 2

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.

Upper Lid

Group	Value	95% CI
Asymptomatic	7.94	± 8.450
Symptomatic	14.91	± 12.562

Lower

Group	Value	95% CI
Asymptomatic	5.89	± 6.184
Symptomatic	12.19	± 12.210

Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part1: Dailies Aqua Comfort Plus) Secondary · VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 4

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

Group	Value	95% CI
Test 1 (Dailies Aqua Comfort Plus)	76.24	± 23.999

Relationship Between End of Day Comfort Scores and Tear Meniscus Height (Part1: Dailies Aqua Comfort Plus) Secondary · VAS, and TMH 14 Hours Follow-up at Visit 4

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

Group	Value	95% CI
Test 1 (Dailies Aqua Comfort Plus)	76.24	± 23.999

Relationship Between End of Day Comfort Scores and Lid Margin Staining (Part1: Dailies Aqua Comfort Plus) Secondary · VAS, and Lid Margin staining 14 Hours Follow-up at Visit 4

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

Group	Value	95% CI
Test 1 (Dailies Aqua Comfort Plus)	76.24	± 23.999

Relationship Between End of Day Comfort Scores and Non-invasive Tear Break-up Time (Part1: Dailies Aqua Comfort Plus) Secondary · VAS, and NIBUT 14 Hours Follow-up at Visit 4

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

Group	Value	95% CI
Test 1 (Dailies Aqua Comfort Plus)	76.24	± 23.999

Relationship Between End of Day Comfort Scores and Density of White Blood Cells Lower Lid (Part1: Dailies Aqua Comfort Plus) Secondary · VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2

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

Group	Value	95% CI
Test 1 (Dailies Aqua Comfort Plus)	67.05	± 30.322

Relationship Between End of Day Comfort Scores and Density of White Blood Cells Upper Lid (Part1: Dailies Aqua Comfort Plus) Secondary · VAS, and WBC before lens removal 6 Hours Follow-up at Visit 2

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

Group	Value	95% CI
Test 1 (Dailies Aqua Comfort Plus)	67.05	± 30.322

Relationship Between End of Day Comfort Scores and Tear Film Osmolarity (Part2: Acuvue Oasys 1-Day) Secondary · VAS, and Tear Film Osmolarity 14 Hours Follow-up at Visit 8

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

Group	Value	95% CI
Test 2 (Acuvue Oasys 1-Day)	85.28	± 18.439

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.