Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks

• Sponsor: Alcon, a Novartis Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02939170
• Collaborator: (none)
• Enrollment: 87
• Location: 1
• Arms: 2
• Actual Duration (Days): 18
• Patients Per Site Per Month: 147.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the impact of back surface molded marks (MM) applied to delefilcon A contact lenses as measured by the incidence of ocular discomfort device-related adverse events with DAILIES TOTAL1® Multifocal contact lenses with molded marks (DT1 MF MM) and current DAILIES TOTAL1® Multifocal contact lenses (DT1 MF).

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: Delefilcon A Multifocal Contact Lenses with Molded Mark; Device: Delefilcon A Multifocal Contact Lenses	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Initial Performance of a Daily Disposable Contact Lens Featuring Molded Marks
• Actual Study Start Date: Nov 14, 2016
• Actual Primary Completion Date: Dec 2, 2016
• Actual Study Completion Date: Dec 2, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DT1 MF MM Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours	Device: Delefilcon A Multifocal Contact Lenses with Molded Mark
Active Comparator: DT1 MF Delefilcon A multifocal contact lenses worn bilaterally for 9 hours	Device: Delefilcon A Multifocal Contact Lenses; Other Names: DAILIES TOTAL1® Multifocal (DT1 MF)

Outcome Measures

Primary Outcome Measures

1. Incidence of Ocular Discomfort Device-related Adverse Events (AE) [Day 1 at Hour 9]

   An 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 investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.

Secondary Outcome Measures

1. Ocular Staining [Day 1 at Hour 9]

   Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.

2. Limbal Hyperemia [Day 1 at Hour 9]

   Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.

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 wearer of commercial DAILIES TOTAL1® contact lenses;

• Have spectacles in current prescription available to be worn in conjunction with the investigational product;

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

• Best corrected distance visual acuity (BCVA) greater than or equal to 20/25 in each eye;

• 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;

• Any use of systemic or ocular medications for which contact lens wear could be contraindicated;

• History of herpetic keratitis, refractive surgery or irregular cornea;

• A pathologically dry eye that precludes contact lens wear;

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

• Monocular (only 1 eye with functional vision);

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon, a Novartis Company

Investigators

• Study Director: Clinical Manager, CTM, Alcon, A Novartis Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon, a Novartis Company
• ClinicalTrials.gov Identifier: NCT02939170
• Other Study ID Numbers: CLO870-C001
• First Posted: Oct 19, 2016
• Last Update Posted: Jul 2, 2018
• Last Verified: Dec 1, 2017

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 5 study centers located in the United States.
Pre-assignment Detail	Of the 87 enrolled, 7 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (80).

Arm/Group Title	DT1 MF MM	DT1 MF
Arm/Group Description	Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally (in both eyes) for 9 hours	Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	40
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	DT1 MF MM	DT1 MF	Total
Arm/Group Description	Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours	Delefilcon A multifocal contact lenses worn bilaterally for 9 hours	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.2 (9.47)	36.1 (10.07)	36.2 (9.71)
Sex: Female, Male (Count of Participants)
Female	31 77.5%	28 70%	59 73.8%
Male	9 22.5%	12 30%	21 26.3%

Outcome Measures

1. Primary Outcome

Title	Incidence of Ocular Discomfort Device-related Adverse Events (AE)
Description	An 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 investigational medical device (test article). Ocular discomfort device-related AE was defined as an ocular AE classified as "Related" to study device and deemed to be related to ocular discomfort.
Time Frame	Day 1 at Hour 9

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	DT1 MF MM	DT1 MF
Arm/Group Description	Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours	Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
Measure Participants	40	40
Measure Eyes	80	80
Number [Events]	0	1

2. Secondary Outcome

Title	Ocular Staining
Description	Assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Ocular staining was categorized by corneal staining, conjunctival staining, and limbal staining. Both eyes contributed to the analysis.
Time Frame	Day 1 at Hour 9

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	DT1 MF MM	DT1 MF
Arm/Group Description	Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours	Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
Measure Participants	40	40
Measure Eyes	80	80
Corneal Staining, Grade 0	62	63
Corneal Staining, Grade 1	14	17
Corneal Staining, Grade 2	4	0
Corneal Staining, Grade 3	0	0
Corneal Staining, Grade 4	0	0
Conjunctival Staining, Grade 0	60	61
Conjunctival Staining, Grade 1	15	15
Conjunctival Staining, Grade 2	5	4
Conjunctival Staining, Grade 3	0	0
Conjunctival Staining, Grade 4	0	0
Limbal Staining, Grade 0	72	67
Limbal Staining, Grade 1	7	13
Limbal Staining, Grade 2	1	0
Limbal Staining, Grade 3	0	0
Limbal Staining, Grade 4	0	0

3. Secondary Outcome

Title	Limbal Hyperemia
Description	Hyperemia (excess of blood) was assessed by the Investigator through slit-lamp examination and graded on a 5-point scale, where 0=none and 4=severe. Both eyes contributed to the analysis.
Time Frame	Day 1 at Hour 9

Outcome Measure Data

Analysis Population Description

Safety Analysis Set

Arm/Group Title	DT1 MF MM	DT1 MF
Arm/Group Description	Delefilcon A multifocal contact lenses with molded marks on back surface worn bilaterally for 9 hours	Delefilcon A multifocal contact lenses worn bilaterally for 9 hours
Measure Participants	40	40
Measure Eyes	80	80
Grade 0	60	52
Grade 1	20	27
Grade 2	0	1
Grade 3	0	0
Grade 4	0	0

Adverse Events

Time Frame	Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (1 day). AEs are reported as pre-treatment and treatment-emergent.
Adverse Event Reporting Description	An 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 investigational medical device (test article). AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
Arm/Group Title	Pre-treatment		DT1 MF MM		DT1 MF
Arm/Group Description	All subjects who consented to participate in the study prior to initiation of study treatment		All subjects exposed to delefilcon A multifocal contact lenses with molded marks		All subjects exposed to delefilcon A multifocal contact lenses
All Cause Mortality
	Pre-treatment		DT1 MF MM		DT1 MF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/40 (0%)		0/40 (0%)
Serious Adverse Events
	Pre-treatment		DT1 MF MM		DT1 MF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Pre-treatment		DT1 MF MM		DT1 MF
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/40 (0%)		0/40 (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.