Marketed Contact Lens Real World Through Focus Curve

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02679976
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 1
• Patients Per Site Per Month: 29.5

Study Details

Study Description

Brief Summary

This is a single-visit prospective study to establish a real world Marketed Contact Lens 'Through Focus Curve' (TFC) measurement by comparing the consistency of vision between myopes and hyperopes. 33 subjects will be enrolled (at least 15 myopes and 15 hyperopes), who are 40 years of age or older, for a 1-visit, 4-hour study for measurements to be taken.

Condition or Disease	Intervention/Treatment	Phase
Visual Acuity	Device: etafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Study Lens (etafilcon A) for Multifocal All Subjects in this study will wear the same contact lenses. However subjects wil be stratified as Hyperopes or Myopes using a 1:1 allocation. The study lens will be worn for a period of approximately 4 hours to allow lenses to settle on the eyes.	Device: etafilcon A; Marketed Multifocal Contact Lens

Outcome Measures

Primary Outcome Measures

1. Distance Binocular LogMAR Visual Acuity [4 Hr. Post Fitting]

   Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

2. Near Binocular LogMAR Visual Acuity [4 Hr. Post Fitting]

   Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

3. Intermediate Binocular LogMAR Visual Acuity [4 Hr. Post Fitting]

   intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

• The subject must be ≥40 years of age.

• The subjects' optimal vertexed spherical equivalent distance correction must be between -6.00 Diopters (D) and +4.00 D in each eye.

• The subject's refractive cylinder must be ≤ -0.75 D in each eye.

• The subject's ADD power must be in the range of +0.75 to +2.50 D in each eye.

• The subject must have best corrected visual acuity of 20/25 or better for each eye.

• The subject can be either a new contact lens wearer or an existing soft contact lens wearer.

Exclusion Criteria:

• Currently pregnant or lactating.

• Any ocular or systemic allergies that contraindicate contact lens wear.

• Any ocular or systemic disease, autoimmune disease, or use of medication that contraindicates contact lens wear.

• Any ocular abnormality that may interfere with contact lens wear.

• Use of any ocular medication, with the exception of rewetting drops.

• Any previous intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)

• Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, and conjunctival injection) which may contraindicate contact lens wear.

• History of herpetic keratitis.

• Any ocular infection or inflammation.

• Any corneal distortion or irregular cornea.

• History of binocular vision abnormality or strabismus.

• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV).

• History of diabetes.

• Participant in unrelated research involving test product within 30 days before planned study visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optometry Technology Group, Ltd.	London		United Kingdom	SW1E 6AU

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: NCT02679976
• Other Study ID Numbers: CR-5728
• First Posted: Feb 11, 2016
• Last Update Posted: Sep 15, 2016
• Last Verified: Jul 1, 2016

Study Results

Participant Flow

Pre-assignment Detail	A total of 30 subjects were enrolled into this study. Subjects were stratified as either Hyperope or Myopes using a 1:1 allocation. All enrolled subjects completed the study.

Arm/Group Title	Etafilcon A (Multi-focal)
Arm/Group Description	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Period Title: Overall Study
STARTED	30
Hyperopes	16
Myopes	14
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Etafilcon A (Multi-focal)
Arm/Group Description	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Overall Participants	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.7 (7.37)
Sex: Female, Male (Count of Participants)
Female	18 60%
Male	12 40%
Race/Ethnicity, Customized (participants) [Number]
Asian	2 6.7%
American Indian Or Alaska Native	0 0%
Black or African American	16 53.3%
Native Hawaiian or Other Pacific Islander	0 0%
White	10 33.3%
Other	2 6.7%
Region of Enrollment (participants) [Number]
United Kingdom	30 100%

Outcome Measures

1. Primary Outcome

Title	Distance Binocular LogMAR Visual Acuity
Description	Distance Binocular LogMAR Visual Acuity was measured at 4m for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Time Frame	4 Hr. Post Fitting

Outcome Measure Data

Analysis Population Description

The analysis population includes all subjects that completed the study without a major protocol deviation.

Arm/Group Title	Etafilcon A (Multi-focal)- Hyperopes	Etafilcon A (Multi-focal)- Myopes
Arm/Group Description	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Measure Participants	16	14
Low Luminance; N=16, N=14	-1.072 (0.8748)	-0.904 (1.1423)
Medium Luminance; N=16, N=14	0.9017 (0.450)	0.557 (0.9465)
High Luminance; N=16, N=14	1.488 (0.6960)	1.471 (1.650)

2. Primary Outcome

Title	Near Binocular LogMAR Visual Acuity
Description	Near Binocular LogMAR Visual Acuity was measured at 40cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Time Frame	4 Hr. Post Fitting

Outcome Measure Data

Analysis Population Description

The analysis population includes all subjects that completed the study without a major protocol deviation.

Arm/Group Title	Etafilcon A (Multi-focal)- Hyperopes	Etafilcon A (Multi-focal)- Myopes
Arm/Group Description	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Measure Participants	16	14
Low Luminance; N=16, N=14	-2.278 (1.6989)	-2.261 (1.7030)
Medium Luminance; N=16, N=14	-0.591 (1.4003)	-0.650 (1.5274)
High Luminance; N=16, N=14	0.828 (0.9910)	0.786 (1.0480)

3. Primary Outcome

Title	Intermediate Binocular LogMAR Visual Acuity
Description	intermediate Binocular LogMAR Visual Acuity was measured at 67cm for Low luminance ( 2.5 CD/M^2 ), Medium luminance ( 50 CD/M^2 ) and High luminance ( 250 CD/M^2 )
Time Frame	4 Hr. Post Fitting

Outcome Measure Data

Analysis Population Description

The analysis population includes all subjects that completed the study without a major protocol deviation.

Arm/Group Title	Etafilcon A (Multi-focal)- Hyperopes	Etafilcon A (Multi-focal)- Myopes
Arm/Group Description	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
Measure Participants	16	14
Low Luminance; N=16, N=14	-1.544 (1.0355)	-1.318 (1.4770)
Medium Luminance; N=16, N=14	-0.075 (0.8367)	0.043 (1.1410)
High Luminance; N=16, N=14	1.056 (0.7616)	1.157 (0.7037)

Adverse Events

Arm/Group Title	Etafilcon A (Multi-focal)
Arm/Group Description	All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
All Cause Mortality
	Etafilcon A (Multi-focal)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Etafilcon A (Multi-focal)
	Affected / at Risk (%)	# Events
Total	0/30 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A (Multi-focal)
	Affected / at Risk (%)	# Events
Total	0/30 (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.