Product Performance of a New Silicone Hydrogel Contact Lens

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04901897
• Collaborator: (none)
• Enrollment: 805
• Locations: 35
• Arms: 3
• Actual Duration (Months): 2.3
• Patients Per Site: 23
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses when worn by current soft contact lens wearers on a daily disposable wear basis.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: kalifilcon A; Device: delefilcon A; Device: senofilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 805 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
• Actual Study Start Date: Jul 31, 2019
• Actual Primary Completion Date: Oct 9, 2019
• Actual Study Completion Date: Oct 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: kalifilcon A kalifilcon A daily disposable contact lens	Device: kalifilcon A; kalifilcon A daily disposable contact lens
Active Comparator: delefilcon A DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Device: delefilcon A; DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
Active Comparator: senofilcon A Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens	Device: senofilcon A; Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens

Outcome Measures

Primary Outcome Measures

1. Mean Change in logMAR Contact Lens Visual Acuity [Baseline, 2 Week Follow up]

   logMAR is the logarithm of the minim angle of resolution

2. Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day" [2 Week Follow up]

3. Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day" [2 Week Follow up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.

• myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.

• correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.

• free of any anterior segment disorders.

• adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.

• access to internet connection and personal email to send/receive emails.

• habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.

Exclusion Criteria:

• participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.

• have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.

• have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.

• using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.

• refractive astigmatism of greater than 0.75 D in either eye.

• anisometropia (spherical equivalent) of greater than 2.00 D.

• amblyopic.

• have had any corneal surgery (e.g., refractive surgery).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch Site 433	Birmingham	Alabama	United States	35216
2	Bausch Site 431	Scottsdale	Arizona	United States	85254
3	Bausch Site 406	Azusa	California	United States	91702
4	Bausch Site 430	Los Angeles	California	United States	90013
5	Bausch Site 419	San Diego	California	United States	92123
6	Bausch Site 435	San Francisco	California	United States	94112
7	Bausch Site 432	Sunnyvale	California	United States	94087
8	Bausch Site 409	Torrance	California	United States	90503
9	Bausch Site 416	Denver	Colorado	United States	80246
10	Bausch Site 415	Jacksonville	Florida	United States	32256
11	Bausch Site 434	Jacksonville	Florida	United States	32256
12	Bausch Site 405	Sarasota	Florida	United States	34237
13	Bausch Site 412	Decatur	Georgia	United States	30035
14	Bausch Site 401	'Aiea	Hawaii	United States	96701
15	Bausch Site 437	Honolulu	Hawaii	United States	96814
16	Bausch Site 414	Leavenworth	Kansas	United States	66048
17	Bausch Site 413	Portland	Maine	United States	04101
18	Bausch Site 421	Sterling Heights	Michigan	United States	48312
19	Bausch Site 429	Edina	Minnesota	United States	55436
20	Bausch Site 422	Raytown	Missouri	United States	64133
21	Bausch Site 407	Saint Louis	Missouri	United States	63144
22	Bausch Site 418	Warrensburg	Missouri	United States	64093
23	Bausch Site 424	Jamestown	New York	United States	14701
24	Bausch Site 403	Vestal	New York	United States	13850
25	Bausch Site 417	Raleigh	North Carolina	United States	27603
26	Bausch Site 411	Fargo	North Dakota	United States	58103
27	Bausch Site 423	Miamisburg	Ohio	United States	45342
28	Bausch Site 425	West Chester	Ohio	United States	45069
29	Bausch Site 428	Grants Pass	Oregon	United States	97526
30	Bausch Site 420	State College	Pennsylvania	United States	16801
31	Bausch Site 427	Warwick	Rhode Island	United States	02888
32	Bausch 410	Brentwood	Tennessee	United States	37027
33	Bausch Site 408	Memphis	Tennessee	United States	33119
34	Bausch Site 404	Nashville	Tennessee	United States	37205
35	Bausch Site 426	League City	Texas	United States	77573

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Robert Steffen, Bausch & Lomb Incorporated

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 28, 2019

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT04901897
• Other Study ID Numbers: 893
• First Posted: May 26, 2021
• Last Update Posted: Jul 8, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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.: No
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Kalifilcon A	Delefilcon A	Senofilcon A
Arm/Group Description	kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Period Title: Overall Study
STARTED	398	202	205
COMPLETED	393	200	203
NOT COMPLETED	5	2	2

Baseline Characteristics

Arm/Group Title	Kalifilcon A	Delefilcon A	Senofilcon A	Total
Arm/Group Description	kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens	Total of all reporting groups
Overall Participants	398	202	205	805
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.5 (5.72)	30.0 (6.11)	29.3 (5.78)	30.3 (5.95)
Sex: Female, Male (Count of Participants)
Female	262 65.8%	125 61.9%	140 68.3%	527 65.5%
Male	136 34.2%	77 38.1%	65 31.7%	278 34.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.3%	1 0.5%	0 0%	2 0.2%
Asian	56 14.1%	30 14.9%	26 12.7%	112 13.9%
Native Hawaiian or Other Pacific Islander	3 0.8%	4 2%	1 0.5%	8 1%
Black or African American	47 11.8%	17 8.4%	25 12.2%	89 11.1%
White	281 70.6%	147 72.8%	146 71.2%	574 71.3%
More than one race	10 2.5%	3 1.5%	7 3.4%	20 2.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Change in logMAR Contact Lens Visual Acuity
Description	logMAR is the logarithm of the minim angle of resolution
Time Frame	Baseline, 2 Week Follow up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Kalifilcon A	Delefilcon A	Senofilcon A
Arm/Group Description	kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Measure Participants	398	202	205
Measure eyes	796	404	410
Mean (Standard Deviation) [logMAR]	-0.056 (0.0727)	-0.069 (0.0733)	-0.069 (0.0718)

2. Primary Outcome

Title	Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
Time Frame	2 Week Follow up

Outcome Measure Data

Analysis Population Description

Participants with 2 week follow up and responded to the question.

Arm/Group Title	Kalifilcon A	Delefilcon A	Senofilcon A
Arm/Group Description	kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Measure Participants	391	200	199
Count of Participants [Participants]	317 79.6%	160 79.2%	166 81%

3. Primary Outcome

Title	Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"
Time Frame	2 Week Follow up

Outcome Measure Data

Analysis Population Description

Participants with 2 week follow up and responded to the question.

Arm/Group Title	Kalifilcon A	Delefilcon A	Senofilcon A
Arm/Group Description	kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens	DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses	Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
Measure Participants	392	201	201
Count of Participants [Participants]	358 89.9%	184 91.1%	188 91.7%

Adverse Events

Time Frame	2 weeks
Adverse Event Reporting Description	Adverse events occurring after signing of informed consent and through the participant's end of participation in the study were reported.
Arm/Group Title	Kalifilcon A		Delefilcon A		Senofilcon A
Arm/Group Description	kalifilcon A daily disposable contact lens kalifilcon A: kalifilcon A daily disposable contact lens		DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses delefilcon A: DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses		Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens senofilcon A: Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
All Cause Mortality
	Kalifilcon A		Delefilcon A		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/398 (0%)		0/202 (0%)		0/205 (0%)
Serious Adverse Events
	Kalifilcon A		Delefilcon A		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/398 (0%)		0/202 (0%)		0/205 (0%)
Other (Not Including Serious) Adverse Events
	Kalifilcon A		Delefilcon A		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/398 (0%)		0/202 (0%)		0/205 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Please contact sponsor directly for details.