The Effects of Contact Lenses With Experimental Dye on Visual Function

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03556579
• Collaborator: (none)
• Enrollment: 62
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.2
• Patients Per Site Per Month: 14.7

Study Details

Study Description

Brief Summary

This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: senofilcon A with new UV blocker; Device: senofilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Effects of Contact Lenses With Experimental Dye on Visual Function
• Actual Study Start Date: May 15, 2018
• Actual Primary Completion Date: Sep 20, 2018
• Actual Study Completion Date: Sep 20, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test/Control For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.	Device: senofilcon A with new UV blocker; Test Lens; Device: senofilcon A; Control Lens
Experimental: Control/Test For Visit 1, subjects will be randomly assigned to 1 of 2 contralateral lens sequences (Right: Test, Left: Control) OR (Right: Control, Left: Test). Then for visit 2, subjects will be randomly assigned to the same 1 of 2 contralateral lens sequences again.	Device: senofilcon A with new UV blocker; Test Lens; Device: senofilcon A; Control Lens

Outcome Measures

Primary Outcome Measures

1. Two-Point Light Spread Function [Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2]

   The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.

2. Halos [Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2]

   The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.

3. Starburts [Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2]

   The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.

Secondary Outcome Measures

1. Glare Disability Threshold [Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1]

   The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups.

2. Photostress Recovery Time [Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1]

   Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups.

3. Glare Discomfort [Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1]

   The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups.

4. Heterochromatic Contrast Threshold [Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1]

   Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 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 65 (inclusive) years of age at the time of screening.

4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.

5. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.

6. The subject has a best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or breastfeeding.

2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.

4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.

5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

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

7. Multifocal, toric or extended wear contact lens correction.

8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.

9. History of binocular vision abnormality or strabismus.

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

11. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).

12. Any ocular infection.

13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Center for Sight	Statesboro	Georgia	United States	30642

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 7, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT03556579
• Other Study ID Numbers: CR-6100
• First Posted: Jun 14, 2018
• Last Update Posted: Nov 18, 2019
• Last Verified: Oct 1, 2019

• 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 62 subjects were into this study. Of those enrolled, 60 were assigned and administered a study lens. Two subjects were enrolled but not administered a study lens. All 60 subjects completed the study.
Pre-assignment Detail	Subjects were stratified into two age groups: 18-39 and 40-65 using a 2:1 allocation. Subjects were randomized at each visit using a contralateral design.

Arm/Group Title	OD:Test, OS:Control/ OD:Test, OS:Control	OD:Test, OS:Control/ OD:Control, OS:Test	OD:Control, OS:Test/ OD:Test, OS:Control	OD:Control, OS:Test/ OD:Control, OS:Test
Arm/Group Description	Subjects that were randomized to receive the Test lens in their right eye and the Control lens in their left eye at both visit 1 and visit 2.	Subjects that were randomized to receive at visit 1 the Test lens in their right eye and the Control lens in their left eye and at visit 2 was randomized to receive the Control lens in their right eye and the Test lens in their left eye.	Subjects that were randomized to receive at visit 1 the Control lens in their right eye and the Test lens in their left eye and at visit 2 was randomized to receive the Test lens in their right eye and the Control lens in their left eye.	Subjects that were randomized to receive the Control lens in their right eye and the Test lens in their left eye at both visit 1 and visit 2.
Period Title: Visit 1
STARTED	16	14	14	16
COMPLETED	16	14	14	16
NOT COMPLETED	0	0	0	0
Period Title: Visit 1
STARTED	16	14	14	16
COMPLETED	16	14	14	16
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Safety Population
Arm/Group Description	All Subjects that were Fit with at least one study lens.
Overall Participants	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.8 (11.22)
Sex: Female, Male (Count of Participants)
Female	49 81.7%
Male	11 18.3%
Race/Ethnicity, Customized (Count of Participants) [Number]
American Indian or Alaska Native	1 1.7%
Black or African American	22 36.7%
White	35 58.3%
Other	2 3.3%
Region of Enrollment (Count of Participants)
United States	60 100%

Outcome Measures

1. Primary Outcome

Title	Two-Point Light Spread Function
Description	The two-point light spread function was assessed at visit 2 for each subject eye under two conditions with a distance filter and without a distance filter. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Two-point light spread function is defined that the as the minimum distance (mm) that two points of light are completely distinct. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and light source combination was reported across age groups.
Time Frame	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2

Outcome Measure Data

Analysis Population Description

All subjects that completed the study without a major protocol deviation impacting any primary endpoint.

Arm/Group Title	Testing With Additional Light Source	Control With Additional Source	Test Without Additional Light Source	Control Without Additional Light Source
Arm/Group Description	Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.	Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
Measure Participants	54	54	54	54
Measure Eyes	54	54	54	54
with distance filter	5.36 (3.132)	6.71 (2.521)	6.47 (3.304)	7.48 (3.149)
Without Dustance Filter	2.29 (1.129)	3.37 (1.214)	3.05 (1.205)	3.78 (1.472)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Without Additional Light Source, Control Without Additional Light Source
	Comments	Without Distance Filter
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.68
	Confidence Interval	(2-Sided) 95%; -1.01 to -0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.162
	Estimation Comments	Mean difference was calculated as Test - Control

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Testing With Additional Light Source, Control With Additional Source
	Comments	Without Distance Filter
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.13
	Confidence Interval	(2-Sided) 95%; -1.45 to -0.81
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.162
	Estimation Comments	Mean difference was calculated as Test - Control

2. Primary Outcome

Title	Halos
Description	The appearance of Halos was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Halos were quantified as the diameter (mm) of the outer edges of the Halo. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Time Frame	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2

Outcome Measure Data

Analysis Population Description

All subjects that completed the study without a major protocol deviation impacting any primary endpoint.

Arm/Group Title	Testing With Additional Light Source	Control With Additional Source	Test Without Additional Light Source	Control Without Additional Light Source
Arm/Group Description	Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.	Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
Measure Participants	54	54	54	54
Measure Eyes	54	54	54	54
Mean (Standard Deviation) [mm]	29.20 (15.777)	52.57 (22.758)	39.09 (14.524)	46.73 (18.355)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Without Additional Light Source, Control Without Additional Light Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-8.86
	Confidence Interval	(2-Sided) 95%; -13.16 to -4.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.173
	Estimation Comments	Mean difference was calculated as Test - Control

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Testing With Additional Light Source, Control With Additional Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-24.93
	Confidence Interval	(2-Sided) 95%; -29.24 to -20.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.173
	Estimation Comments	Mean difference was calculated as Test - Control

3. Secondary Outcome

Title	Glare Disability Threshold
Description	The Glare disability threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported across age groups.
Time Frame	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Outcome Measure Data

Analysis Population Description

All subjects that completed the study without a major protocol deviation impacting any primary endpoint.

Arm/Group Title	Test Without Additional Light Source	Control Without Additional Light Source
Arm/Group Description	Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
Measure Participants	54	54
Measure eyes	54	54
Mean (Standard Deviation) [log units]	0.98 (0.166)	1.16 (0.140)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Testing With Additional Light Source, Control With Additional Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the lower limit of the 95% confidence interval was above 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.022
	Estimation Comments	Mean Difference was calculated as Test minus Control

4. Secondary Outcome

Title	Photostress Recovery Time
Description	Photostress Recovery (PR) Time (seconds) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Subjects are exposed to a target, once the target was able to be comfortable viewed by the subject, a bright bleaching light covered it. As the afterimage fades, participants will gradually be able to re-gain sight of the target. PR time will be recorded as the time it takes following exposure to the bleaching light to regain sight of the target. PR Times are positive values where smaller times indicate better lens performance. The average PR Time (seconds) for each lens type was reported across age groups.
Time Frame	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.

Arm/Group Title	Test Without Additional Light Source	Control Without Additional Light Source
Arm/Group Description	Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
Measure Participants	54	54
Measure eyes	54	54
Mean (Standard Deviation) [seconds]	8.83 (8.668)	17.28 (15.230)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Testing With Additional Light Source, Control With Additional Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Ratio
	Estimated Value	0.55
	Confidence Interval	(2-Sided) 95%; 0.46 to 0.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Glare Discomfort
Description	The Glare discomfort (change in palpebral fissure height) was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported across age groups.
Time Frame	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits wihtout a major protocol deviation impacting a primary endpoint.

Arm/Group Title	Test Without Additional Light Source	Control Without Additional Light Source
Arm/Group Description	Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
Measure Participants	54	54
Measure eyes	54	54
Mean (Standard Deviation) [mm]	2.26 (1.249)	2.90 (1.569)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Testing With Additional Light Source, Control With Additional Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.61
	Confidence Interval	(2-Sided) 95%; -1.07 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.230
	Estimation Comments	Mean Difference was calculated as Test minus Control

6. Secondary Outcome

Title	Heterochromatic Contrast Threshold
Description	Heterochromatic Contrast Threshold was assessed for each eye at visit 1. The study lenses in this visit were assessed without the additional light sourced used at visit 2. Heterochromatic contrast thresholds are measured as thresholds to a variable wavelength central target presented on a short-wave (460nm) sky-light background. Thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported across age groups.
Time Frame	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation impacting a primary endpoint.

Arm/Group Title	Test Without Additional Light Source	Control Without Additional Light Source
Arm/Group Description	Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
Measure Participants	54	54
Measure eyes	54	54
Mean (Standard Deviation) [log units]	1.01 (0.170)	1.24 (0.164)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Testing With Additional Light Source, Control With Additional Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the lower limit of the 95% confidence interval was above 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 95%; 0.14 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.022
	Estimation Comments	Mean Difference was calculated as Test minus Control

7. Primary Outcome

Title	Starburts
Description	The appearance of starbursts was assessed at visit 2 for each subject eye. Measurements for this metric were taken twice, with the presence of an additional UV/HEV light source and without this additional light source (the same study lenses were used for both measurements). Starbursts are defined as the diameter (mm) of the light's lateral spread. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type and light source combination was reported across age groups.
Time Frame	Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2

Outcome Measure Data

Analysis Population Description

Subjects that have completed all study visits without a major protocol deviation impacting a primary endpoint.

Arm/Group Title	Testing With Additional Light Source	Control With Additional Source	Test Without Additional Light Source	Control Without Additional Light Source
Arm/Group Description	Subjects that wore the Test lens in either eye during visit 2. This lens was measured using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured using an additional light source.	Subjects that wore the Test lens in either eye during visit 2. This lens was measured without using an additional light source.	Subjects that wore the Control lens in either eye during visit 2. This lens was measured without using an additional light source.
Measure Participants	54	54	54	54
Measure eyes	54	54	54	54
Mean (Standard Deviation) [mm]	45.66 (24.228)	75.12 (27.370)	55.78 (23.037)	69.60 (25.914)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Testing With Additional Light Source, Control With Additional Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-30.56
	Confidence Interval	(2-Sided) 95%; -31.66 to -25.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.555
	Estimation Comments	Mean difference was calculated as Test minus Control.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Test Without Additional Light Source, Control Without Additional Light Source
	Comments
	Type of Statistical Test	Superiority
	Comments	Superiority was concluded if the upper limit of the 95% confidence interval was below 0. No sample size calculation was performed for this study since historical data was not available for either study lens for any of the primary endpoints.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-15.38
	Confidence Interval	(2-Sided) 95%; -20.48 to -10.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.555
	Estimation Comments	Mean difference was calculated as Test Minus Control.

Adverse Events

Time Frame	Throughout the entire duration of the study. One to 14 days per subject.
Arm/Group Title	Test		Control
Arm/Group Description	All subjects that wore the Test lens at either visit 1 or visit 2.		All subjects that wore the Control lens at either visit 1 or visit 2.
All Cause Mortality
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Serious Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Test		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/60 (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.