Evaluation of an Investigational Multifocal Lens

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02223754
• Collaborator: (none)
• Enrollment: 371
• Locations: 20
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 18.6
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

The purpose of this study is to test the performance of an investigational multifocal test soft contact lens.

Condition or Disease	Intervention/Treatment	Phase
Presbyopia	Device: lotrafilcon B; Device: etafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 371 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: lotrafilcon B / etafilcon A Subject randomized to this sequence will first be dispensed the lotrafilcon B contact lens and then the etafilcon A contact lens.	Device: lotrafilcon B; Soft contact lens to be worn as daily wear, monthly replacement modality.; Other Names: AirOptix Aqua Multifocal ; Device: etafilcon A; Soft contact lens to be worn as daily wear, daily disposable modality.
Experimental: etafilcon A / lotrafilcon B Subject randomized to this sequence will first be dispensed the etafilcon A contact lens and then the lotrafilcon B contact lens.	Device: lotrafilcon B; Soft contact lens to be worn as daily wear, monthly replacement modality.; Other Names: AirOptix Aqua Multifocal ; Device: etafilcon A; Soft contact lens to be worn as daily wear, daily disposable modality.

Outcome Measures

Primary Outcome Measures

1. Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire [8 -12 days post wear]

   CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).

2. Distance Binocular Visual Acuity (LogMAR) [8- 12 Days post wear]

   Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.

3. Intermediate Binocular Visual Acuity (LogMAR) [8-12 days post wear]

   Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.

4. Near Binocular Visual Acuity (LogMAR) [8-12 days post wear]

   Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.

5. Corneal Staining [8 - 12 Days post wear]

   Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.

6. Bulbar Conjunctival Injection [8- 12 Days post wear]

   The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.

7. Limbal Conjunctival Injection [8- 12 Days post wear]

   The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.

8. Contact Lens Fitting [8- 12 Days post wear]

   Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. The subjects were required to have read, understand, and signed the Statement of Informed Consent and receive a fully executed copy of the form.

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

3. Between 40 and 70 years of age.

4. Subjects must own a wearable pair of spectacles, if required for their distance vision.

5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per wear day, for 1 month of more duration)

6. Already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire"*

7. The subject's vertex corrected spherical equivalent distance refraction was required to be in the range +3.50 to -5.75 in each eye.

8. Refractive cylinder ≤ -0.75 D in each eye.

9. ADD power in the range +0.75 D to +2.50 D in each eye.

10. Best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who became pregnant during the study were discontinued).

2. Any ocular or systemic allergies that may have contraindicated contact lens wear.

3. Any ocular or systemic disease, autoimmune disease, or use of medication, that may have contraindicated contact lens wear.

4. Any ocular abnormality that may have interfered with contact lens wear.

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

6. Any previous intraocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).

7. History of herpetic keratitis.

8. History of binocular vision abnormality or strabismus.

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

10. History of diabetes.

11. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

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

13. Any ocular infection or inflammation.

14. Any corneal distortion or irregular cornea.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Montgomery	Alabama	United States	36109
2		Mission Viejo	California	United States	92691
3		Jacksonville	Florida	United States	32205
4		Jacksonville	Florida	United States	32250
5		Orange Park	Florida	United States	32065
6		Saint Augustine	Florida	United States	32092
7		Tallahassee	Florida	United States	32308
8		Tampa	Florida	United States	33625
9		Winter Park	Florida	United States	32792
10		Roswell	Georgia	United States	30076
11		Pittsburg	Kansas	United States	66762
12		East Lansing	Michigan	United States	48823
13		Vestal	New York	United States	13850
14		Denver	North Carolina	United States	28037
15		Powell	Ohio	United States	43065
16		Springfield	Ohio	United States	45503
17		Warwick	Rhode Island	United States	02888
18		Memphis	Tennessee	United States	38119
19		Tyler	Texas	United States	75701
20		Salem	Virginia	United States	24153

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: NCT02223754
• Other Study ID Numbers: CR-5593
• First Posted: Aug 22, 2014
• Last Update Posted: Jun 19, 2018
• Last Verified: Jul 1, 2016

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	This study enrolled a total of 371 subjects. Of those enrolled subjects 49 did not meet the eligibility criteria and 322 subjects were dispensed a study lens. Of the dispensed subjects 297 completed the study and 25 were discontinued from the study.

Arm/Group Title	Etafilcon A / Lotrafilcon B	Lotrafilcon B/ Etafilcon A
Arm/Group Description	Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.	Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
Period Title: Period 1
STARTED	163	159
COMPLETED	159	144
NOT COMPLETED	4	15
Period Title: Period 1
STARTED	159	144
COMPLETED	156	141
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Etafilcon A / Lotrafilcon B	Lotrafilcon B / Etafilcon A	Total
Arm/Group Description	Subjects that were randomized to this sequence and were dispensed a study lens.	Subjects that were randomized to this sequence and were dispensed a study lens.	Total of all reporting groups
Overall Participants	163	159	322
Age (years) [Mean (Standard Deviation) ]
Hyperopes, N=59, N=53, N=112	52.3 (6.59)	51.9 (7.04)	52.1 (6.78)
Myopes, N=104, N=106, N=210	49.3 (6.10)	49.5 (5.77)	49.4 (5.92)
Sex: Female, Male (Count of Participants)
Female	128 78.5%	120 75.5%	248 77%
Male	35 21.5%	39 24.5%	74 23%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	0 0%	1 0.6%	1 0.3%
Asian	1 0.6%	3 1.9%	4 1.2%
Black or African American	15 9.2%	10 6.3%	25 7.8%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
White	147 90.2%	144 90.6%	291 90.4%
Other	0 0%	1 0.6%	1 0.3%
Region of Enrollment (participants) [Number]
United States	163 100%	159 100%	322 100%

Outcome Measures

1. Primary Outcome

Title	Overall Quality of Vision Using the Contact Lens User Experience (CLUE) TM Questionnaire
Description	CLUE Overall Quality of Vision is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).
Time Frame	8 -12 days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
Measure Participants	275	275
Hyperopes, N=94, N=94	51.15 (21.647)	54.28 (20.749)
Myopes, N=181, N=181	53.55 (18.644)	51.84 (19.319)

2. Primary Outcome

Title	Distance Binocular Visual Acuity (LogMAR)
Description	Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast.
Time Frame	8- 12 Days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that have completed all study visits without a major protocol deviation.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B during either the first or second period of the study.
Measure Participants	275	275
Hyperopes, N=94, N=94	-0.069 (0.0908)	-0.066 (0.0982)
Myopes, N=180, N=181	-0.100 (0.0991)	-0.093 (0.0981)

3. Primary Outcome

Title	Intermediate Binocular Visual Acuity (LogMAR)
Description	Intermediate time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time Frame	8-12 days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
Measure Participants	275	275
Hyperopes, N=94, N=94	-0.061 (0.0829)	-0.050 (0.0897)
Myopes, N=180, N=181	-0.081 (0.0803)	-0.063 (0.0894)

4. Primary Outcome

Title	Near Binocular Visual Acuity (LogMAR)
Description	Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast.
Time Frame	8-12 days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
Measure Participants	275	275
Hyperopes, N=94, N=94	0.050 (0.0970)	0.074 (0.1035)
Myopes, N=180, N=181	0.034 (0.1039)	0.049 (0.1176)

5. Primary Outcome

Title	Corneal Staining
Description	Corneal staining is evaluated using Sodium Fluorescein strips. The Fluorescien strip was lightly placed on the subject's inferior palpebral conjunctiva. The corneal Staining was graded using the scale Grade 0: No Staining, Grade 1: Trace(Minimal superficial staining or stippling), Grade 2: Mild (Regional or diffuse punctate staining), Grade 3:Moderate(Significant dense coalesced staining, corneal abrasion or foreign body tracks.), Grade 4 Severe(Severe abrasions greater than 2 mm in diameter, ulcerations, epithelial loss, or full thickness abrasion.). The data was dichotomized into two group subjects with grade 3 or higher staining, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time Frame	8 - 12 Days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
Measure Participants	275	275
Measure Subject Eyes	550	550
Hyperopes, N=188, N=188	0.0	0.0
Myopes, N=362, N=362	0.0	0.0

6. Primary Outcome

Title	Bulbar Conjunctival Injection
Description	The bulbar is the scelra. Bulbar Conjunctival Injection was assessed using an Efron Grading scale by 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time Frame	8- 12 Days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
Measure Participants	275	275
Measure Subject Eyes	550	550
Hyperopes, N=188, N=188	0.0	0.0
Myopes, N=362 , N=362	0.0	0.0

7. Primary Outcome

Title	Limbal Conjunctival Injection
Description	The Limbus is the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjunctival Injection was assesed using the Efron grading scale in 1 unit increments. Grade 0: Normal, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate, Grade 4:Severe. The data was dichotomized into two group subjects with grade 3 or higher Conjunctival injection, and those subjects with less than Grade 3. Below the percentage of subject eyes with grade 3 or higher is reported for each lens.
Time Frame	8- 12 Days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
Measure Participants	275	275
Measure Subject Eyes	550	550
Hyperopes, N=188, N=188	0.0	0.0
Myopes, N=362, N=362	0.0	0.0

8. Primary Outcome

Title	Contact Lens Fitting
Description	Contact Lens fitting is reported as a binary response. Yes- acceptable lens fit, No- unacceptable lens fit. The percentage of subject eyes with acceptable fit is reported.
Time Frame	8- 12 Days post wear

Outcome Measure Data

Analysis Population Description

The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on subject eyes.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.	Subjects that received the lotrafilcon B during either the first or second period of the study.
Measure Participants	275	275
Measure Subject Eyes	550	550
Hyperopes, N=188, N=188	100	100
Myopes, N=362, N=362	99.5	100

Adverse Events

Time Frame	Approximately 8-12 days per intervention.
Arm/Group Title	Etafilcon A		Lotrafilcon B
Arm/Group Description	Subjects that received the etafilcon A contact lens during either the first or second period of the study.		Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
All Cause Mortality
	Etafilcon A		Lotrafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A		Lotrafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/307 (0%)		0/318 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A		Lotrafilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/307 (0%)		0/318 (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.