CLARITI (TM) 1-Day Multifocal Contact Lenses Performance and Acceptance Evaluation

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02147093
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 13.6

Study Details

Study Description

Brief Summary

A comparative evaluation of a newly marketed multifocal contact lens with a single vision contact lens when used with near vision spectacles. The evaluation was to quantify the difference between the two test corrections.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia Correction	Device: Test (multi-focal); Device: Control (Sphere)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Actual Study Start Date: May 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Control (sphere) /Test (multi-focal) Subjects were first fitted with Control lens (sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (multi-focal) for one week.	Device: Test (multi-focal); contact lens was to be worn a daily wear.; Other Names: Clariti 1 Day filcon II 3 ; Device: Control (Sphere); contact lens was to be worn a daily wear with spectacles; Other Names: filcon II 3
Other: Test (sphere) /Control (multi-focal) Subjects were first fitted with the Test lens (multi-focal) for one week. Subjects were then fitted with Control lens (sphere) and a pair of reading glasses for one week.	Device: Test (multi-focal); contact lens was to be worn a daily wear.; Other Names: Clariti 1 Day filcon II 3 ; Device: Control (Sphere); contact lens was to be worn a daily wear with spectacles; Other Names: filcon II 3

Outcome Measures

Primary Outcome Measures

1. Distance LogMAR Visual Acuity [7 days post wear]

   Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)

2. Near LogMAR Visual Acuity [7 days post wear]

   Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 45 years or more

2. Spectacle or soft contact lens wearer

3. Refraction: best sphere (corrected for back vertex distance) -6.00 Diopters (D) to +4.00 D; Astigmatism - 0.00 D to -0.75 D; Near addition for 40 cm; Medium Add: +1.50 D to +2.00 D; High Add: +2.25 D to +2.50 D

4. Best spectacle corrected visual acuity of 6/9 or better in each eye

5. Willingness to adhere to the instructions set forth in the clinical protocol

6. Signature of the subject Informed Consent form after review of Information to Participant document.

Exclusion Criteria:

1. Systemic or ocular allergies which might interfere with contact lens wear

2. Systemic disease which might interfere with contact lens wear

3. Ocular disease which might interfere with contact lens wear (e.g. hypothesia, insufficient lacrimal secretion)

4. Use of medication which might interfere with contact lens wear

5. Active ocular infection

6. Use of ocular medication

7. Significant ocular anomaly

8. Presence of two or more corneal scars in either eye

9. Monovision contact lens wearers

10. Pregnancy or lactation

11. Any medical condition that might be prejudicial to the study

12. Participants non-able to give consent or from a vulnerable group

13. Infectious disease (for example, hepatitis, tuberculosis, etc.) or a contagious immunosuppressive disease (such as HIV, AIDS, etc.)

14. Employees or family member of the investigational clinic (e.g. investigator, coordinator, technician)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		London		United Kingdom	SW1E6AU

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT02147093
• Other Study ID Numbers: CR-5175
• First Posted: May 26, 2014
• Last Update Posted: Jun 19, 2018
• Last Verified: Jun 1, 2017

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Recruitment Details	A total of 41 subjects were enrolled in this study. Of the enrolled subjects 1 did not meet the eligibility criteria and 40 subjects were dispensed a study lens. Of the dispensed subjects, 3 were discontinued and 37 subjects completed the study.

Arm/Group Title	Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)	Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)
Arm/Group Description	Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.	Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
Period Title: Period 1
STARTED	20	20
COMPLETED	20	19
NOT COMPLETED	0	1
Period Title: Period 1
STARTED	20	19
COMPLETED	18	19
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)	Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)	Total
Arm/Group Description	All subjects that were randomized to sequence and were dispensed a study lens.	All subjects that were randomized to sequence and were dispensed a study lens.	Total of all reporting groups
Overall Participants	20	20	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.20 (7.682)	58.00 (9.067)	56.78 (8.490)
Sex: Female, Male (Count of Participants)
Female	14 70%	12 60%	26 65%
Male	6 30%	8 40%	14 35%
Region of Enrollment (participants) [Number]
United Kingdom	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Distance LogMAR Visual Acuity
Description	Distance time controlled LogMAR (Logarithm of the Minimum Angle of Resolution) Visual Acuity was carried out binocularly, at 4m (meter) under 250 cd/m^2 and 2.5 cd/m^2 (candela per square meter) luminance. The test was presented under the two conditions; High luminance (250 cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (2.5 cd/m^2) High Contrast (90%)
Time Frame	7 days post wear

Outcome Measure Data

Analysis Population Description

All subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Control (Filcon II 3-sphere)	Test (Filcon II 3-multi-focal)
Arm/Group Description	Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.	Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
Measure Participants	37	37
High Contrast-Distance-Standard High Luminance	-0.466 (0.9995)	-0.972 (1.0104)
Low Contrast-Distance-Standard High Luminance	-2.842 (1.6850)	-3.768 (1.8023)
High Contrast-Distance-Standard Low Luminance	-2.834 (1.0042)	-3.700 (0.8939)

2. Primary Outcome

Title	Near LogMAR Visual Acuity
Description	Near time controlled LogMAR Visual Acuity was carried out binocularly, at 4cm under 250 cd/m^2 and 50 cd/m^2 luminance. The test was presented on under the two conditions; High Luminance (250cd/m^2) High Contrast (90%) & Low Contrast (10%) and Low Luminance (50cd/m^2) High Contrast (90%)
Time Frame	7 days post wear

Outcome Measure Data

Analysis Population Description

All subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Control (Filcon II 3-sphere)	Test (Filcon II 3-multi-focal)
Arm/Group Description	Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.	Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
Measure Participants	37	37
High Contrast-Near-Standard High Luminance	-1.455 (0.6309)	-2.545 (1.1240)
Low Contrast-Near-Standard High Luminance	-2.151 (1.0221)	-3.820 (1.4124)
High Contrast-Near-Standard Low Luminance	-1.878 (1.0546)	-3.441 (1.3941)

Adverse Events

Time Frame	Throughout duration of the study(approximately 4 months).
Arm/Group Title	Control (Filcon II 3-sphere)		Test (Filcon II 3-multi-focal)
Arm/Group Description	Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.		Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
All Cause Mortality
	Control (Filcon II 3-sphere)		Test (Filcon II 3-multi-focal)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control (Filcon II 3-sphere)		Test (Filcon II 3-multi-focal)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Control (Filcon II 3-sphere)		Test (Filcon II 3-multi-focal)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	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.

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.