Two Daily Disposable Contact Lenses in Symptomatic Patients

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03628599
• Collaborator: (none)
• Enrollment: 39
• Locations: 4
• Arms: 2
• Actual Duration (Months): 1.4
• Patients Per Site: 9.8
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of DAILIES TOTAL1® and ACUVUE OASYS® 1-DAY and with respect to visual acuity in a symptomatic study population of monthly or bi-weekly replacement lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Delefilcon A contact lenses; Device: Senofilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Two Daily Disposable Contact Lenses in Symptomatic Patients
• Actual Study Start Date: Aug 13, 2018
• Actual Primary Completion Date: Sep 25, 2018
• Actual Study Completion Date: Sep 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TOTAL1 Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality	Device: Delefilcon A contact lenses; Water Gradient silicon hydrogel daily disposable contact lenses; Other Names: DAILIES TOTAL1® (DT1)
Active Comparator: 1-DAY Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality	Device: Senofilcon A contact lenses; Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology; Other Names: ACUVUE OASYS® 1-DAY

Outcome Measures

Primary Outcome Measures

1. Monocular Corrected Distance Visual Acuity (VA) [Week 4]

   Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to understand and must sign an IRB-approved informed consent form;

• Soft contact lens wearers in both eyes during the past 3 months;

• Best-corrected visual acuity (BCVA) 20/25 or better in each eye;

• Willing to wear study lenses at least 3 days per week and at least 8 hours per day;

• Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria:

• Infection, inflammation, abnormality, condition, disease, surgery, or use of medications, as specified in the protocol;

• Intolerance, hypersensitivity, or allergy to any component of the study products;

• Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;

• Monocular (only one eye with functional vision).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Investigative Site	Bloomington	Illinois	United States	61701
2	Alcon Investigative Site	Pittsburg	Kansas	United States	66762
3	Alcon Investigative Site	Powell	Ohio	United States	43065
4	Alcon Investigative Site	Warwick	Rhode Island	United States	02888

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Alcon Research, Alcon Research

Study Documents (Full-Text)

• Study Protocol - Jul 20, 2018
• Statistical Analysis Plan - Aug 13, 2018

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT03628599
• Other Study ID Numbers: CLS312-P001
• First Posted: Aug 14, 2018
• Last Update Posted: Jul 5, 2019
• Last Verified: Jun 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.: No
• Keywords provided by Alcon Research: Symptomatic
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 4 investigational sites located in the United States.
Pre-assignment Detail	Of the 39 enrolled, 2 subjects were discontinued (1 screen failure, 1 due to lens power not available) prior to randomization. This reporting group includes all randomized subjects (37).

Arm/Group Title	TOTAL1	1-DAY
Arm/Group Description	Delefilcon A contact lenses worn bilaterally (in both eyes) for 4 weeks in a daily disposable modality	Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Period Title: Overall Study
STARTED	18	19
COMPLETED	18	18
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	TOTAL1	1-DAY	Total
Arm/Group Description	Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality	Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality	Total of all reporting groups
Overall Participants	18	19	37
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.2 (8.4)	36.9 (9.2)	36.6 (8.7)
Sex: Female, Male (Count of Participants)
Female	12 66.7%	16 84.2%	28 75.7%
Male	6 33.3%	3 15.8%	9 24.3%
Race/Ethnicity, Customized (Count of Participants)
White	18 100%	18 94.7%	36 97.3%
Black or African American	0 0%	1 5.3%	1 2.7%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Other	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Monocular Corrected Distance Visual Acuity (VA)
Description	Monocular (each eye) corrected (with spectacles or other visual corrective devices) VA was performed under dimmed room illumination using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart at distance. VA was reported in logMAR ("logarithm of the minimum angle of resolution"), with a lower logMAR indicating better visual acuity. No inferential hypotheses was planned for this endpoint.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

Safety Analysis Set with non-missing response

Arm/Group Title	TOTAL1	1-DAY
Arm/Group Description	Delefilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality	Senofilcon A contact lenses worn bilaterally for 4 weeks in a daily disposable modality
Measure Participants	18	18
Measure Eyes	36	36
Mean (Standard Deviation) [logMAR]	-0.01 (0.04)	-0.02 (0.05)

Adverse Events

Time Frame	Dispense through study completion, an average of 4 weeks
Adverse Event Reporting Description	An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the study lenses. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set. "At Risk" population for ocular AEs is included with unit of "eyes."
Arm/Group Title	TOTAL1 Ocular - Right Eye		TOTAL1 Ocular - Left Eye		TOTAL1 Non-ocular		1-DAY Ocular - Right Eye		1-DAY Ocular - Left Eye		1-DAY Non-ocular
Arm/Group Description	Right eyes exposed to delefilcon A contact lenses		Left eyes exposed to delefilcon A contact lenses		All subjects exposed to delefilcon A contact lenses		Right eyes exposed to senofilcon A contact lenses		Left eyes exposed to senofilcon A contact lenses		All subjects exposed to senofilcon A contact lenses
All Cause Mortality
	TOTAL1 Ocular - Right Eye		TOTAL1 Ocular - Left Eye		TOTAL1 Non-ocular		1-DAY Ocular - Right Eye		1-DAY Ocular - Left Eye		1-DAY Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)		0/18 (0%)		0/19 (0%)		0/19 (0%)		0/19 (0%)
Serious Adverse Events
	TOTAL1 Ocular - Right Eye		TOTAL1 Ocular - Left Eye		TOTAL1 Non-ocular		1-DAY Ocular - Right Eye		1-DAY Ocular - Left Eye		1-DAY Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)		0/18 (0%)		0/19 (0%)		0/19 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	TOTAL1 Ocular - Right Eye		TOTAL1 Ocular - Left Eye		TOTAL1 Non-ocular		1-DAY Ocular - Right Eye		1-DAY Ocular - Left Eye		1-DAY Non-ocular
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)		0/18 (0%)		1/19 (5.3%)		1/19 (5.3%)		1/19 (5.3%)
Eye disorders
Conjunctival disorder	0/18 (0%)		0/18 (0%)		0/18 (0%)		1/19 (5.3%)		1/19 (5.3%)		0/19 (0%)
Infections and infestations
Sinusitis	0/18 (0%)		0/18 (0%)		0/18 (0%)		0/19 (0%)		0/19 (0%)		1/19 (5.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.