Pilot Dispensing Evaluation of a Plus Power Lens

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01228591
• Collaborator: (none)
• Enrollment: 38
• Locations: 3
• Arms: 2
• Duration (Months): 1
• Patients Per Site: 12.7
• Patients Per Site Per Month: 12.4

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.

Condition or Disease	Intervention/Treatment	Phase
Hyperopia	Device: Acuvue Advance Plus; Device: Acuvue Advance	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Acuvue Advance Plus/ Acuvue Advance Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.	Device: Acuvue Advance Plus; Silicone hydrogel contact lens.; Device: Acuvue Advance; Silicone hydrogel contact lens
Other: Acuvue Advance/Acuvue Advance Plus Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.	Device: Acuvue Advance Plus; Silicone hydrogel contact lens.; Device: Acuvue Advance; Silicone hydrogel contact lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity One Week After Lens Wear [1 week]

   Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.

2. Visual Acuity at Time of Initial Fit [After 10-15 minutes of lens wear]

   Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.

Secondary Outcome Measures

1. Contact Lens Comfort Using Contact Lens User Experience (CLUE) [1 week]

   The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.

2. Subject Reported Vision Using Contact Lens User Experience (CLUE). [1 week]

   Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.

3. Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE) [Baseline]

   Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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. CLUE scores have a range of 0-120.

4. Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE) [Baseline]

   Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject must be at least 18 years of age and no more than 45 years of age.

• The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).

• The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.

• Any cylinder power must be ≤ 0.75D.

• The subject must have visual acuity best correctable to 20/25+3 or better for each eye.

• The subject must read and sign the Statement of Informed Consent.

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

Exclusion Criteria:

• Ocular or systemic allergies or disease which might interfere with contact lens wear.

• Systemic disease or use of medication which might interfere with contact lens wear.

• Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.

• Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.

• Any ocular infection.

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

• Pregnancy or lactation.

• Diabetes.

• Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).

• Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.

• Need any near correction.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Winter Park	Florida	United States
2		New York	New York	United States
3		Nanticoke	Pennsylvania	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: NCT01228591
• Other Study ID Numbers: CR-1636BB
• First Posted: Oct 26, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Hyperopia

Study Results

Participant Flow

Recruitment Details	This is a 3 site, 3 visit, randomized, double-masked, bilateral crossover trial comparing Acuvue Advance to Acuvue Advance Plus lenses.
Pre-assignment Detail	Of the 38 subjects enrolled, 2 were ineligible and not-randomized, 3 discontinued, and 33 completed as cohort.

Arm/Group Title	Acuvue Advance Plus/ Acuvue Advance	Acuvue Advance/ Acuvue Advance Plus
Arm/Group Description	Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second	Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
Period Title: Baseline
STARTED	18	18
COMPLETED	17	16
NOT COMPLETED	1	2
Period Title: Baseline
STARTED	17	16
COMPLETED	17	16
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	17	16
COMPLETED	17	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	Subjects who were randomized and successfully completed the study.
Overall Participants	33
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	33 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.8 (5.66)
Sex: Female, Male (Count of Participants)
Female	21 63.6%
Male	12 36.4%
Region of Enrollment (participants) [Number]
United States	33 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity One Week After Lens Wear
Description	Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.

Arm/Group Title	Acuvue Advance Plus	Acuvue Advance
Arm/Group Description	Acuvue Advance Plus contact lenses-Binocular measurements	Acuvue Advance contact lenses - Binocular Measurements
Measure Participants	33	33
Measure eyes	66	66
Low Luminance/ High Contrast (Binocular)	0.11 (0.082)	0.10 (0.063)
Low Luminance/ High Contrast (Monocular)	0.14 (0.100)	0.14 (0.088)
High Luminance/ Low Contrast (Binocular)	0.12 (0.075)	0.13 (0.067)
High Luminance/ Low Contrast (Monocular)	0.22 (0.108)	0.21 (0.097)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acuvue Advance Plus, Acuvue Advance
	Comments	For Low Luminance/ High Contrast grouping (Monocular): Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance). Ha: The test lens (Acuvue Advance Plus) will be <= to the control lens (Acuvue Advance).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority is assessed with a margin of -0.05logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.007
	Confidence Interval	(2-Sided) 95%; -0.0044 to 0.0187
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0059
	Estimation Comments	The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Acuvue Advance Plus, Acuvue Advance
	Comments	High Luminance/ Low Contrast grouping (Binocular): Ho: The test lens (Acuvue Advance Plus) will be non-inferior to the control lens (Acuvue Advance). Ha: The test lens (Acuvue Advance Plus) will be <= to the control lens (Acuvue Advance).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority is assessed with a margin of -0.05 logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.003
	Confidence Interval	(2-Sided) 95%; -0.0086 to 0.0146
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0059
	Estimation Comments	The mean difference is defined by: Test lens (Acuvue Advance Plus) - control lens (Acuvue Advance)

2. Primary Outcome

Title	Visual Acuity at Time of Initial Fit
Description	Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
Time Frame	After 10-15 minutes of lens wear

Outcome Measure Data

Analysis Population Description

Analysis is conducted on those were enrolled and completed the trial.

Arm/Group Title	Acuvue Advance Plus	Acuvue Advance
Arm/Group Description	Acuvue Advance Plus contact lenses worn	Acuvue Advance contact lenses worn
Measure Participants	33	33
Measure eyes	66	66
Low Luminance/High Contrast (Binocular)	0.13 (0.087)	0.11 (0.073)
Low Luminance/High Contrast (Monocular)	0.16 (0.106)	0.15 (0.101)
High Luminance/Low Contrast (Binocular)	0.14 (0.076)	0.13 (0.094)
High Luminance/Low Contrast (Monocular)	0.24 (0.123)	0.21 (0.111)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Acuvue Advance Plus, Acuvue Advance
	Comments	For Low Luminance/ High Contrast Grouping (Monocular): Ho: The test lens (Advance Plus) will be non-inferior to the control lens (Advance). Ha: The test lens (Advance Plus) will be <= to the control lens (Advance).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority is assessed with a margin of -0.05 logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.016
	Confidence Interval	(2-Sided) 95%; 0.0041 to 0.0282
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0061
	Estimation Comments	Mean difference represents: Test lens (Advance Plus) - Control lens (Advance).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Acuvue Advance Plus, Acuvue Advance
	Comments	For High Luminance/ Low Contrast Grouping (Binocular): Ho: The test lens (Advance Plus) will be non-inferior from the control lens (Advance). Ha: The test lens (Advance Plus) will be <= to the control lens (Advance).
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority is assessed with a margin of -0.05 logMAR.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.021
	Confidence Interval	(2-Sided) 95%; 0.0090 to 0.3305
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.006
	Estimation Comments	Mean Difference is defined to be: test lens (Advance Plus) - control lens (Advance).

3. Secondary Outcome

Title	Contact Lens Comfort Using Contact Lens User Experience (CLUE)
Description	The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Analysis was on those who were enrolled and completed the study.

Arm/Group Title	Acuvue Advance Plus	Acuvue Advance
Arm/Group Description	Acuvue Advance Plus contact lenses worn.	Acuvue Advance contact lenses worn.
Measure Participants	33	33
Least Squares Mean (Standard Error) [CLUE points]	49.2 (3.28)	50.7 (3.26)

4. Secondary Outcome

Title	Subject Reported Vision Using Contact Lens User Experience (CLUE).
Description	Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Analysis was on those who were enrolled and completed the study.

Arm/Group Title	Acuvue Advance Plus	Acuvue Advance
Arm/Group Description	Acuvue Advance Plus contact lenses worn.	Acuvue Advance contact lenses worn.
Measure Participants	33	33
Least Squares Mean (Standard Error) [CLUE points]	42.5 (2.87)	39.9 (2.86)

5. Secondary Outcome

Title	Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)
Description	Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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. CLUE scores have a range of 0-120.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Analysis was on those who were enrolled and completed the study.

Arm/Group Title	Acuvue Advance Plus	Acuvue Advance
Arm/Group Description	Acuvue Advance Plus contact lenses worn	Acuvue Advance contact lenses worn
Measure Participants	33	33
Least Squares Mean (Standard Error) [CLUE points]	65.3 (3.14)	59.0 (3.19)

6. Secondary Outcome

Title	Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)
Description	Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses 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 with a range of 0 to 120.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Subjects analyzed included only those who were enrolled and completed the study.

Arm/Group Title	Acuvue Advance Plus	Acuvue Advance
Arm/Group Description	Acuvue Advance Plus contact lenses worn	Acuvue Advance contact lenses worn
Measure Participants	33	33
Least Squares Mean (Standard Error) [CLUE points]	46.7 (3.90)	49.6 (3.98)

Adverse Events

Time Frame	1 month, Study took place from Oct 1, 2010-Nov 12, 2010
Arm/Group Title	Acuvue Advance Plus		Acuvue Advance
Arm/Group Description	Acuvue Advance Plus contact lenses		Acuvue Advance contact lenses
All Cause Mortality
	Acuvue Advance Plus		Acuvue Advance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Acuvue Advance Plus		Acuvue Advance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (0%)
Other (Not Including Serious) Adverse Events
	Acuvue Advance Plus		Acuvue Advance
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/33 (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.