Clinical Characterization of Symptomatic Populations

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03319212
• Collaborator: (none)
• Enrollment: 105
• Locations: 2
• Arm: 1
• Actual Duration (Months): 10.5
• Patients Per Site: 52.5
• Patients Per Site Per Month: 5

Study Details

Study Description

Brief Summary

This is an unmasked, non-randomized, single arm, stratified, dispensing investigation of symptomatic and asymptomatic subject populations. Subjects will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: senofilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 105 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Characterization of Symptomatic Populations
• Actual Study Start Date: Sep 29, 2017
• Actual Primary Completion Date: Aug 15, 2018
• Actual Study Completion Date: Aug 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Active Comparator Subjects that are between the ages 18-55 and are current spherical soft contact lens wearers will be assigned to a single study lens type to be worn bilaterally for approximately 4 weeks followed by no contact lens wear for 1 week.	Device: senofilcon A contact lenses; Senofilcon A Daily Disposable Contact Lenses

Outcome Measures

Primary Outcome Measures

1. Meibomian Gland Imaging [4-Week Follow-up]

   Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%.

2. Meibomian Gland Expressibility [4-Week Follow-up]

   Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian Gland Secretion Score was calculated by adding the grades for the 15 glands assessed. Mean and standard deviation for total grade per region and total Meibomian Gland Secretion Score were reported for each stratum. Total scores range from 0 to 15 were lower score indicate worsening meibomian gland expressability.

3. Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings [4-Week Follow-up]

   Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal: Irregularity: Notching of Margin Vascularity of Lid Margin: Telangiectasia Meibomian Gland Pouting, Plugging, or Capping Lid/Lash Margin Debris Findings. The number of positive findings (yes) was reported for each group.

4. Lid Wiper Epitheliopathy [4-Week Follow-up]

   Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades indicate worsening lid wiper epitheliopathy.

5. Conjunctival Folds [4-Week Follow-up]

   Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm).

Secondary Outcome Measures

1. Conjunctival Redness [4-Week Follow-up]

   Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe.

2. Conjunctival Staining [4-Week Follow-up]

   Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining).

3. Corneal Staining [4-Week Follow-up]

   Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (>1mm). Corneal staining area was evaluated using the following the scale: Grade 0 = 0% of region covered, Grade 1 = 10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4 = 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered, Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered, and Grade 10 = 100% of region covered. The following scale was used in the grading of corneal staining depth: Grade 0 = None, Grade 0 = Superficial epithelial, Grade 2 = Full epithelial, and Grade 3 = Stromal glow.

4. Tear Film Lipid Layer Thickness [4-Week Follow-up]

   Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm.

5. Tear Film Stability [4-Week Follow-up]

   Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. Three measurements were taken on each eye. The average NIBUT was reported for each group.

6. Tear Film Lipid Pattern [4-Week Follow-up]

   Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.

3. Between 18 and 55 (inclusive) years of age at the time of screening.

4. Be a current soft contact lens wearer in both eyes with a minimum of 3 days/week wear time over the last 1 month by self-report.

5. Have a baseline CLDEQ-8 score of either:

6. 7 or lower

7. 15 or greater

8. Subjects must possess a functional / usable pair of spectacles and bring them to the visit (only if applicable - to the investigators discretion).

9. Subjects must pass a pre-screening questionnaire.

10. Subjects must be willing to discontinue all contact lens wear for approximately 1 week/

11. Subjects must present to visit 1 with their habitual lenses on eye for at least 6 hours.

Exclusion Criteria:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Currently pregnant or lactating, by self-report.

2. Any ocular or systemic allergies, disease or use of medication which may interfere with contact lens wear (at the discretion of the investigator).

3. Any active ocular abnormalities/conditions that may interfere with contact lens wear (at the discretion of the investigator).

4. Any infectious diseases (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV), by self-report.

5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

6. Habitual contact lens wear modality as extended wear (≥1 night per month of extended wear).

7. Habitual contact lens is rigid gas permeable, toric, monovision or multi-focal

8. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)

9. Participation in any contact lens or lens care product clinical trial within 2 weeks prior to study enrollment.

10. Employee or employee's immediate family member of clinical site (e.g., Investigator, Coordinator, Technician).

11. Current habitual use of Restasis, Xiidra, ocular steroids, or any medication (RX or OTC) that may interfere with contact lens wear (at the discretion of the investigator).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VRC-East	Jacksonville	Florida	United States	32256
2	University of Waterloo Center for Contact Lens Research	Waterloo	Ontario	Canada

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 3, 2017

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03319212
• Other Study ID Numbers: CR-5969
• First Posted: Oct 24, 2017
• Last Update Posted: Oct 15, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	A total of 105 subjects were enrolled into this study. Of those enrolled 81, were dispensed a study lens while 24 subjects failed to meet all eligibility criteria. Of those dispensed a study lens, 73 completed the study while 8 subjects were discontinued. All subjects were disepsned the same study lens senofilcon A.
Pre-assignment Detail	Subjects were stratified into two subject groups: symptomatic (baseline CLDEQ-8 score of 15 or greater) and asymptomatic (baseline CLDEQ-8 score of 7 or lower).

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study. All subjects wore the senofilcon A lens in both eyes throughout the entire duration.
Period Title: Overall Study
STARTED	29	52
COMPLETED	26	47
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Asymptomatic	Symptomatic	Total
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study.	Total of all reporting groups
Overall Participants	29	52	81
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	28.76 (7.229)	28.17 (9.096)	28.38 (8.4333)
Sex: Female, Male (Count of Participants)
Female	18 62.1%	36 69.2%	54 66.7%
Male	11 37.9%	16 30.8%	27 33.3%
Race/Ethnicity, Customized (Number) [Number]
Asian	7 24.1%	20 38.5%	27 33.3%
Black or African American	1 3.4%	2 3.8%	3 3.7%
White	21 72.4%	27 51.9%	48 59.3%
Other	0 0%	3 5.8%	3 3.7%
Region of Enrollment (Count of Participants)
United States	11 37.9%	14 26.9%	25 30.9%
Canada	18 62.1%	38 73.1%	56 69.1%

Outcome Measures

1. Primary Outcome

Title	Meibomian Gland Imaging
Description	Meibomian gland imaging was assessed in each each subject eye, at baseline, 4-Week Follow-up (during lens wear) and the the 5-Week Follow-up on subjects' bare eyes. Meibomian gland imaging is expressed interms of area of loss using the following grading scale: Degree 0 ≈ 0%; Degree 1 ≤ 25%; Degree 2 26% - 50%; Degree 3 51% - 75%; Degree 4 ≥ 75%.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
Degree 0	10	4
Degree 1	23	66
Degree 2	18	16
Degree 3	1	8

2. Primary Outcome

Title	Meibomian Gland Expressibility
Description	Meibomian glands were assessed in the three regions of each lower eyelid: temporal, central, and nasal. Approximately five glands are expressed per region with each use of the Meibomian Gland Evaluator. Secretions for each of the 5 glands selected within the three regions were graded using the following secretion grading scale: Grade 0 = No Secretion (Includes capped orifices), Grade 1 = Inspissated (semi-solid, toothpaste-like consistency), Grade 2 = Colored/Cloudy Liquid, Grade 3 = Clear Liquid Oil. The total grades for 5 glands per region was calculated for each subject. The total Meibomian Gland Secretion Score was calculated by adding the grades for the 15 glands assessed. Mean and standard deviation for total grade per region and total Meibomian Gland Secretion Score were reported for each stratum. Total scores range from 0 to 15 were lower score indicate worsening meibomian gland expressability.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
Central Lower Lid	9.04 (5.068)	8.07 (5.055)
Temporal Lower Lid	8.71 (4.795)	7.94 (4.803)
Nasal Lower Lid	7.94 (4.976)	6.54 (4.571)
Total Score	25.69 (13.964)	22.55 (12.649)

3. Primary Outcome

Title	Lid Margin Evaluation: Number of Eyes With Abnormal Biomicroscopy Findings
Description	Lid margin evaluation was conducted for upper and lower lids for both left and right eyes. The presence of the following biomicroscopy findings were recorded as No/normal or Yes/abnormal: Irregularity: Notching of Margin Vascularity of Lid Margin: Telangiectasia Meibomian Gland Pouting, Plugging, or Capping Lid/Lash Margin Debris Findings. The number of positive findings (yes) was reported for each group.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
Irregularity: Notching of Margin	1	5
Vascularity of Lid Margin: Telangiectasia	12	21
Meibomian Gland Pouting, Plugging, or Capping	12	33
Lid/Lash Margin Debris Findings	0	10

4. Primary Outcome

Title	Lid Wiper Epitheliopathy
Description	Horizontal length of staining and sagittal width of staining were graded for both upper and lower lids for each eye. Average grade was calculated separately for upper and lower lids, and the final grade was calculated as the average grade across upper and lower lids. Mean and standard deviation were reported for the final grade by stratum. Subjects were classified according to their final lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Final Grades range from 0 to 3, where higher final grades indicate worsening lid wiper epitheliopathy.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
Mean (Standard Deviation) [Units on a scale]	0.50 (0.718)	0.28 (0.489)

5. Primary Outcome

Title	Conjunctival Folds
Description	Lid-parallel conjunctival folds (LIPCOF) will be evaluated in the area perpendicular to the temporal and nasal limbus on the bulbar conjunctiva above the lower lid (temporal and nasal LIPCOF, respectively), and classified using the LIPCOF grading scale: 0 = No conjunctival folds, 1 = One permanent and clear parallel fold, 2 = Two permanent and clear parallel folds (normally lower than 0.2mm), and 3 = More than two permanent and clear parallel folds (normally higher than 0.2mm).
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
Temporal- Grade 0	27	45
Temporal- Grade 1	22	41
Temporal- Grade 2	3	8
Temporal- Grade 3	0	0
Nasal- Grade 0	43	55
Nasal- Grade 1	9	30
Nasal- Grade 2	0	9
Nasal- Grade 3	0	0

6. Secondary Outcome

Title	Conjunctival Redness
Description	Limbal and bulbar conjunctival redness were assessed or each quadrant (nasal, temporal, inferior, superior) using the following scale: 0 = Normal, 1 = Trace, 2 = Mild, 3 = Moderate, and 4 = Severe.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	27	48
Measure Eyes	54	96
Bulbar-Nasal- Grade 0	12	11
Bulbar-Nasal- Grade 1	36	72
Bulbar-Nasal- Grade 2	6	13
Bulbar-Nasal- Grade 3	0	0
Bulbar-Nasal- Grade 4	0	0
Bulbar-Temporal- Grade 0	13	12
Bulbar-Temporal- Grade 1	37	73
Bulbar-Temporal- Grade 2	4	11
Bulbar-Temporal- Grade 3	0	0
Bulbar-Temporal- Grade 4	0	0
Bulbar-Inferior-Grade 0	23	27
Bulbar-Inferior-Grade 1	31	66
Bulbar-Inferior-Grade 2	0	3
Bulbar-Inferior-Grade 3	0	0
Bulbar-Inferior-Grade 4	0	0
Bulbar-Superior- Grade 0	23	31
Bulbar-Superior- Grade 1	30	57
Bulbar-Superior- Grade 2	1	8
Bulbar-Superior- Grade 3	0	0
Bulbar-Superior- Grade 4	0	0
Limbal-Nasal- Grade 0	26	28
Limbal-Nasal- Grade 1	25	66
Limbal-Nasal- Grade 2	3	2
Limbal-Nasal- Grade 3	0	0
Limbal-Nasal- Grade 4	0	0
Limbal-Temporal- Grade 0	24	33
Limbal-Temporal- Grade 1	28	58
Limbal-Temporal- Grade 2	2	5
Limbal-Temporal- Grade 3	0	0
Limbal-Temporal- Grade 4	0	0
Limbal-Inferior- Grade 0	27	40
Limbal-Inferior- Grade 1	27	55
Limbal-Inferior- Grade 2	0	1
Limbal-Inferior- Grade 3	0	0
Limbal-Inferior- Grade 4	0	0
Limbal-Superior- Grade 0	25	46
Limbal-Superior- Grade 1	29	45
Limbal-Superior- Grade 2	0	5
Limbal-Superior- Grade 3	0	0
Limbal-Superior- Grade 4	0	0

7. Secondary Outcome

Title	Conjunctival Staining
Description	Conjunctival staining was assessed for each eye by quadrant (Superior, Inferior, Nasal, Temporal) utilizing the following scale: Grade 0 = None (No conjunctival staining), Grade 1 = Trace (Scattered superficial punctate staining), Grade 2 = Mild (Regional or generalized punctate staining), Grade 3 = Moderate (Significant coalesced punctate staining), Grade 4 = Severe (Patch staining).
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	27	48
Measure Eyes	54	96
Nasal- Grade 0	17	17
Nasal- Grade 1	18	51
Nasal- Grade 2	19	28
Nasal- Grade 3	0	0
Temporal- Grade 0	20	29
Temporal- Grade 1	19	51
Temporal- Grade 2	15	16
Temporal- Grade 3	0	0
Inferior-Grade 0	26	30
Inferior-Grade 1	9	51
Inferior-Grade 2	19	13
Inferior-Grade 3	0	2
Superior- Grade 0	28	50
Superior- Grade 1	18	44
Superior- Grade 2	8	2
Superior- Grade 3	0	0

8. Secondary Outcome

Title	Corneal Staining
Description	Corneal staining was assessed for each eye by region (Central, Superior, Inferior, Nasal, Temporal). Corneal staining type was evaluated using the following the scale: Grade 0 = None, Grade 1 = Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate, and Grade 4 = Patch (>1mm). Corneal staining area was evaluated using the following the scale: Grade 0 = 0% of region covered, Grade 1 = 10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4 = 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered, Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered, and Grade 10 = 100% of region covered. The following scale was used in the grading of corneal staining depth: Grade 0 = None, Grade 0 = Superficial epithelial, Grade 2 = Full epithelial, and Grade 3 = Stromal glow.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects dispensed a study lens.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	27	48
Measure Eyes	54	96
Staining Type- Central- Grade 0	51	88
Staining Type- Central- Grade 1	1	5
Staining Type- Central- Grade 2	2	3
Staining Type- Central- Grade 3	0	0
Staining Type-Inferior - Grade 0	48	75
Staining Type-Inferior - Grade 1	5	17
Staining Type-Inferior - Grade 2	1	4
Staining Type-Inferior - Grade 3	0	0
Staining Type-Nasal - Grade 0	49	92
Staining Type-Nasal - Grade 1	4	2
Staining Type-Nasal - Grade 2	1	2
Staining Type-Nasal - Grade 3	0	0
Staining Type-Temporal-Grade 0	51	92
Staining Type-Temporal-Grade 1	2	2
Staining Type-Temporal-Grade 2	1	2
Staining Type-Temporal-Grade 3	0	0
Staining Type- Superior- Grade 0	50	88
Staining Type- Superior- Grade 1	4	6
Staining Type- Superior- Grade 2	0	2
Staining Type- Superior- Grade 3	0	0
Staining- Area- Central- Grade 0	51	89
Staining- Area- Central- Grade 1	1	4
Staining- Area- Central- Grade 2	1	2
Staining- Area- Central- Grade 3	1	1
Staining- Area- Central- Grade 4	0	0
Staining- Area- Central- Grade 5	0	0
Staining- Area- Central- Grade 6	0	0
Staining- Area- Inferior- Grade 0	48	76
Staining- Area- Inferior- Grade 1	3	10
Staining- Area- Inferior- Grade 2	0	8
Staining- Area- Inferior- Grade 3	3	2
Staining- Area- Inferior- Grade 4	0	0
Staining- Area- Inferior- Grade 5	0	0
Staining- Area- Inferior- Grade 6	0	0
Staining- Area-Nasal-Grade 0	49	93
Staining- Area-Nasal-Grade 1	4	2
Staining- Area-Nasal-Grade 2	1	1
Staining- Area-Nasal-Grade 3	0	0
Staining- Area-Nasal-Grade 4	0	0
Staining- Area-Nasal-Grade 5	0	0
Staining- Area-Nasal-Grade 6	0	0
Staining-Area-Temporal-Grade 0	51	92
Staining-Area-Temporal-Grade 1	1	2
Staining-Area-Temporal-Grade 2	2	2
Staining-Area-Temporal-Grade 3	0	0
Staining-Area-Temporal-Grade 4	0	0
Staining-Area-Temporal-Grade 5	0	0
Staining-Area-Temporal-Grade 6	0	0
Staining-Area-Superior-Grade 0	50	89
Staining-Area-Superior-Grade 1	3	4
Staining-Area-Superior-Grade 2	0	3
Staining-Area-Superior-Grade 3	0	0
Staining-Area-Superior-Grade 4	1	0
Staining-Area-Superior-Grade 5	0	0
Staining-Area-Superior-Grade 6	0	0
Staining-Depth-Central-Grade 0	51	89
Staining-Depth-Central-Grade 1	3	7
Staining-Depth-Central-Grade 2	0	0
Staining-Depth-Inferior-Grade 0	48	77
Staining-Depth-Inferior-Grade 1	6	19
Staining-Depth-Inferior-Grade 2	0	0
Staining-Depth-Nasal-Grade 0	49	93
Staining-Depth-Nasal-Grade 1	5	3
Staining-Depth-Nasal-Grade 2	0	0
Staining-Depth-Temporal-Grade 0	51	93
Staining-Depth-Temporal-Grade 1	3	3
Staining-Depth-Temporal-Grade 2	0	0
Staining-Depth-Superior-Grade 0	50	89
Staining-Depth-Superior-Grade 1	4	7
Staining-Depth-Superior-Grade 2	0	0

9. Secondary Outcome

Title	Tear Film Lipid Layer Thickness
Description	Tear film lipid layer thickness was measured for each eye using LipiView II. The Review Lipid Images screen provided numerical analysis of the measured lipid layer thickness in nanometers (nm) from 10 (thinnest) to 240 (thickest), with a precision of 1 nm and an accuracy of 10 nm.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
Mean (Standard Deviation) [nm]	66.81 (19.336)	63.00 (16.208)

10. Secondary Outcome

Title	Tear Film Stability
Description	Non-invasive tear break-up time (NIBUT) was measured for each eye to indicate the stability of the tear film. NIBUT is measured as the time interval in seconds after the final blink to the first appearance of distortion in the reflected rings; or to the time that the participant has to blink due to discomfort. Three measurements were taken on each eye. The average NIBUT was reported for each group.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects who have successfully completed all visits and did not substantially deviate from the protocol as determined by the trial cohort review committee prior to database hardlock.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
Mean (Standard Deviation) [seconds]	8.03 (3.846)	6.78 (4.327)

11. Secondary Outcome

Title	Tear Film Lipid Pattern
Description	Tear film lipid pattern was recorded for each eye using the following categories: None, Open Meshwork, Closed (Tight Meshwork), Flow (Wave), Amorphous, Colors, and Other.
Time Frame	4-Week Follow-up

Outcome Measure Data

Analysis Population Description

All subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Asymptomatic	Symptomatic
Arm/Group Description	Subjects with baseline CLDEQ-8 score of 7 or lower were assigned to the asymptomatic group throughout the entire duration of the study	Subjects with baseline CLDEQ-8 score of 15 or greater were assigned to the symptomatic group throughout the entire duration of the study
Measure Participants	26	47
Measure Eyes	52	94
None	0	0
Open Meshwork	6	24
Closed (Tight)	18	22
Flow (Wave)	14	28
Amorphous	11	15
Colors	3	5
Others	0	0

Adverse Events

Time Frame	Throughout the entire duration of the study. Approximately 5 weeks per subject.
Arm/Group Title	Senofilcon A
Arm/Group Description	All subjects that wore the senofilcon A lens at any point throughout the study.
All Cause Mortality
	Senofilcon A
	Affected / at Risk (%)	# Events
Total	0/81 (0%)
Serious Adverse Events
	Senofilcon A
	Affected / at Risk (%)	# Events
Total	0/81 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A
	Affected / at Risk (%)	# Events
Total	0/81 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.