Initial Performance of a Modified Daily Disposable Contact Lens

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02694835
• Collaborator: (none)
• Enrollment: 81
• Arms: 2
• Actual Duration (Days): 21

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® with UV Absorber (DT1 UV) contact lenses compared with current DAILIES TOTAL1® (DT1) contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Delefilcon A contact lenses with UV Absorber; Device: Delefilcon A contact lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• Official Title: Initial Performance of a Modified Daily Disposable Silicone Hydrogel Contact Lens
• Actual Study Start Date: Mar 21, 2016
• Actual Primary Completion Date: Apr 11, 2016
• Actual Study Completion Date: Apr 11, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DT1 UV Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours	Device: Delefilcon A contact lenses with UV Absorber; Other Names: DAILIES TOTAL1® UV (DT1 UV)
Active Comparator: DT1 Delefilcon A contact lenses worn bilaterally for 9 hours	Device: Delefilcon A contact lenses; Other Names: DAILIES TOTAL1® (DT1)

Outcome Measures

Primary Outcome Measures

1. Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs) [Day 1 at Hour 9 ± 3 hours]

   An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Must sign an Informed Consent document;

• Current wearers of commercial DT1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day;

• Spherical contact lens correction within the range of -2.00 to -4.00 Diopter (D) in both eyes;

• Manifest astigmatism less than or equal to 0.75 D (at screening);

• Best-corrected visual acuity (BCVA) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening);

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Eye injury in either eye within 12 weeks prior to study enrollment;

• Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the Investigator;

• Use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear;

• History of herpetic keratitis;

• History of refractive surgery or irregular cornea;

• Pathologically dry eye that precludes contact lens wear;

• Concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial;

• Monocular (only 1 eye with functional vision);

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Clinical Manager, GCRA, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02694835
• Other Study ID Numbers: CLP691-C001
• First Posted: Mar 1, 2016
• Last Update Posted: Mar 13, 2019
• Last Verified: Feb 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
• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 5 investigational sites located in the United States.
Pre-assignment Detail	Of the 81 enrolled, 1 subject exited as a screen failure prior to randomization. This reporting group includes all randomized subjects (80).

Arm/Group Title	DT1 UV	Dailies Total1 (DT1)
Arm/Group Description	Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours	Delefilcon A contact lenses worn bilaterally for 9 hours
Period Title: Overall Study
STARTED	41	39
COMPLETED	41	39
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	DT1 UV	Dailies Total1 (DT1)	Total
Arm/Group Description	Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours	Delefilcon A contact lenses worn bilaterally for 9 hours	Total of all reporting groups
Overall Participants	41	39	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.2 (8.5)	35.3 (9.9)	35.8 (9.2)
Sex: Female, Male (Count of Participants)
Female	34 82.9%	23 59%	57 71.3%
Male	7 17.1%	16 41%	23 28.8%
Race/Ethnicity, Customized (Count of Participants)
White	36 87.8%	35 89.7%	71 88.8%
Black or African American	2 4.9%	0 0%	2 2.5%
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	3 7.3%	2 5.1%	5 6.3%
Native Hawaiian or Other Pacific Island	0 0%	0 0%	0 0%
Multi-Racial	0 0%	0 0%	0 0%
Other	0 0%	2 5.1%	2 2.5%

Outcome Measures

1. Primary Outcome

Title	Incidence (Number) of Ocular Discomfort Device-related Adverse Events (AEs)
Description	An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reported in units of eyes.
Time Frame	Day 1 at Hour 9 ± 3 hours

Outcome Measure Data

Analysis Population Description

Full Analysis Set

Arm/Group Title	DT1 UV	Dailies Total1 (DT1)
Arm/Group Description	Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours	Delefilcon A contact lenses worn bilaterally for 9 hours
Measure Participants	41	39
Measure Eyes	82	78
Count of Units [Eyes]	0	0

Adverse Events

Time Frame	Duration of enrollment = 1 Day
Adverse Event Reporting Description	AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects/eyes exposed to any investigational product evaluated in the study.
Arm/Group Title	DT1 UV		Dailies Total1 (DT1)
Arm/Group Description	Delefilcon A contact lenses with Ultraviolet (UV) Absorber worn bilaterally (in both eyes) for 9 hours		Delefilcon A contact lenses worn bilaterally for 9 hours
All Cause Mortality
	DT1 UV		Dailies Total1 (DT1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)
Serious Adverse Events
	DT1 UV		Dailies Total1 (DT1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	DT1 UV		Dailies Total1 (DT1)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/39 (0%)

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.