Evaluation of the Performance of Investigational Contact Lenses in a Presbyopic Population

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01763047
• Collaborator: (none)
• Enrollment: 298
• Locations: 19
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 15.7
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the performance of a novel multifocal lens system.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 298 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: etafilcon A/lotrafilcon B Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the etafilcon A lens and then wore the lotrafilcon B lens.	Device: etafilcon A; To be worn in a daily wear modality for a minimum of 6 hours per day.; Device: lotrafilcon B; Lenses will be worn in a reuseable modality; cleaned and disinfected each night.; Other Names: AirOptix Aqua Multifocal
Active Comparator: lotrafilcon B/etafilcon A Subjects were randomized to one of two lens wear sequences. Subject randomized to this sequence first wore the lotrafilcon B lens and then wore the etafilcon A lens.	Device: etafilcon A; To be worn in a daily wear modality for a minimum of 6 hours per day.; Device: lotrafilcon B; Lenses will be worn in a reuseable modality; cleaned and disinfected each night.; Other Names: AirOptix Aqua Multifocal

Outcome Measures

Primary Outcome Measures

1. Binocular Distance Visual Acuity (LogMAR) [8-12 days post wear]

   Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)

2. Binocular Near Visual Acuity (logMAR) [8-12 days post wear]

   Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).

3. Percentage of Eyes With Corneal Staining Grade 3 or Higher [8-12 days post wear]

   Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) 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 and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.

4. Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher [8-12 days post wear]

   The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) 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 Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.

5. Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher [8-12 days post wear]

   Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) 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 for the maximum grade of all 4 regions.

6. CLUE 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).

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Subjects must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

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

3. Subjects must be between 40 and 70 years of age.

4. Subjects' spherical equivalent distance refraction must be in the range of -3.75 to +3.75 in each eye.

5. Subjects' refractive cylinder must be less than or equal to 0.75D in each eye.

6. Subjects' ADD power must be in the range of +0.75 to +2.50D in each eye.

7. Subjects' must have the best corrected visual acuity of 20/20-3 or better in each eye.

8. Subjects' should own a wearable pair of spectacles.

9. Subjects' must 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 or more duration).

10. Subjects' must respond positively to at least on symptom on the "Presbyopis Symptoms Questionnaire" or already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.

3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.

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

5. 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.

6. Any ocular infection.

7. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

8. History of binocular vision abnormality or strabismus.

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

10. History of diabetes.

11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Mission Viejo	California	United States
2	RPS	Jacksonville	Florida	United States
3		Jacksonville	Florida	United States
4		Saint Augustine	Florida	United States
5		Tallahassee	Florida	United States
6		Winter Park	Florida	United States
7		Roswell	Georgia	United States
8		Lutherville	Maryland	United States
9		Closter	New Jersey	United States
10		New York	New York	United States
11		Denver	North Carolina	United States
12		Athens	Ohio	United States
13		Kingston	Pennsylvania	United States
14		Warwick	Rhode Island	United States
15		Memphis	Tennessee	United States
16		Amarillo	Texas	United States
17		Tyler	Texas	United States
18		Salt Lake City	Utah	United States
19		Salem	Virginia	United States

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: NCT01763047
• Other Study ID Numbers: CR-5357
• First Posted: Jan 8, 2013
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2016

• Additional relevant MeSH terms: Presbyopia

Study Results

Participant Flow

Pre-assignment Detail	This study enrolled a total of 298 subjects. Subjects were stratified as either Hyperopes or Myopes, which was determined by their sphere power. Of the enrolled subjects 22 did not meet the eligibility criteria and 276 subjects were randomized a study lens. Of the randomized subjects 29 were discontinued and 247 subjects completed the study.

Arm/Group Title	Etafilcon A/ Lotrafilcon B	Lotrafilcon B/ Etafilcon A
Arm/Group Description	Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.	Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
Period Title: Period 1
STARTED	139	137
Myopes	77	76
Hyperopes	62	61
COMPLETED	130	126
NOT COMPLETED	9	11
Period Title: Period 1
STARTED	130	126
Myopes	74	72
Hyperopes	56	54
COMPLETED	126	121
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Etafilcon A/ Lotrafilcon B	Lotrafilcon B/ Etafilcon A	Total
Arm/Group Description	Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.	Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.	Total of all reporting groups
Overall Participants	139	137	276
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.49 (6.626)	50.90 (6.775)	50.69 (6.691)
Sex: Female, Male (Count of Participants)
Female	108 77.7%	108 78.8%	216 78.3%
Male	31 22.3%	29 21.2%	60 21.7%
Race/Ethnicity, Customized (participants) [Number]
American Indian or Alaska Native	2 1.4%	0 0%	2 0.7%
Asian	2 1.4%	3 2.2%	5 1.8%
Black or African American	13 9.4%	10 7.3%	23 8.3%
Native Hawaiian or other Pacific Islander	0 0%	1 0.7%	1 0.4%
White	121 87.1%	123 89.8%	244 88.4%
other	1 0.7%	0 0%	1 0.4%
Region of Enrollment (participants) [Number]
United States	139 100%	137 100%	276 100%

Outcome Measures

1. Primary Outcome

Title	Binocular Distance Visual Acuity (LogMAR)
Description	Distance time controlled LogMAR Visual Acuity was carried out binocularly with high luminance and high contrast, at 4m under 250 cd/m^2. The test was presented under the condition High luminance (250 cd/m^2) High Contrast (90%)
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 each lens and strata.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.	Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
Measure Participants	207	207
Hyperopes, N=91, 91	-0.068 (0.0885)	-0.058 (0.0867)
Myopes, N=116, N=116	-0.109 (0.0826)	-0.107 (0.0835)

2. Primary Outcome

Title	Binocular Near Visual Acuity (logMAR)
Description	Near time controlled LogMAR Visual Acuity was carried out binocularly using High lumiance and High Contrast, at 40cm under 250 cd/m^2. The test was presented under the condition High Luminance (250cd/m^2) High Contrast (90%).
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 each lens and strata.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.	Subjects that were dispensed the lotrafilcon B during either the first or second period of the study.
Measure Participants	207	207
Hyperopes, N=91, N=91	0.063 (0.1070)	0.082 (0.1316)
Myopes, N=116, N=116	0.048 (0.1106)	0.043 (0.0975)

3. Primary Outcome

Title	Percentage of Eyes With Corneal Staining Grade 3 or Higher
Description	Corneal staining was evaluated in 5 corneal regions (Central, Inferior, Nasal, Temporal and Superior) 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 and those subjects with less than Grade 3 for the maximum grade of corneal staining across all 5 regions.
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 for each lens and strata.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that were dispensed the etafilcon A during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.	Subjects that were dispensed the lotrafilcon B during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
Measure Participants	207	207
Measure Subject Eyes	414	414
Hyperopes, N=182, N=182	0.0	0.0
Myopes, N=232, N=232	0.0	0.0

4. Primary Outcome

Title	Percentage of Eyes With Limbal Conjunctival Redness Grade 3 or Higher
Description	The Limbus refers to the 1 to 2mm wide zone of conjunctiva and underlying tissue adjacent to where the cornea joins the sclera. Limbal Conjuctival Redness was graded in 4 regions (Nasal, Temporal, Inferior and Superior) 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 Limbal Conjuctival Redness, and those subjects with less than Grade 3 for the maximum grade of all 4 regions.
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 for each lens and strata.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.	Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
Measure Participants	207	207
Measure Subject Eyes	414	414
Hyperopes, N=182, N=182	0.0	0.0
Myopes, N=232, N=232	0.0	0.0

5. Primary Outcome

Title	Percentage of Eyes With Bulbar Conjunctival Redness Grade 3 or Higher
Description	Bulbar Conjunctival Injection was assessed in 4 regions (Nasal, Temporal, Inferior and Superior) 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 for the maximum grade of all 4 regions.
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 for each lens and strata.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.	Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
Measure Participants	207	207
Measure Subject Eyes	414	414
Hyperopes, N=182, N=182	0.0	0.0
Myopes, N=232, N=232	0.0	0.0

6. Primary Outcome

Title	CLUE 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 consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted on each lens and strata.

Arm/Group Title	Etafilcon A	Lotrafilcon B
Arm/Group Description	Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.	Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
Measure Participants	207	207
Hyperopes, N=91, N=91	46.48 (18.834)	44.79 (18.439)
Myopes, N=116, N=116	47.74 (19.279)	50.17 (20.433)

Adverse Events

Time Frame	Throughout the duration of the study- approximately 3 months
Arm/Group Title	Test (Etafilcon A)		Control (Lotrafilcon B)
Arm/Group Description	Subjects that were dispensed the Test lens (etafilcon A) during either the first or second period of the study.		Subjects that were dispensed the Control lens (lotrafilcon B) during either the first or second period of the study.
All Cause Mortality
	Test (Etafilcon A)		Control (Lotrafilcon B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Test (Etafilcon A)		Control (Lotrafilcon B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/276 (0%)		0/276 (0%)
Other (Not Including Serious) Adverse Events
	Test (Etafilcon A)		Control (Lotrafilcon B)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/276 (0%)		0/276 (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.