Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01055132
• Collaborator: (none)
• Enrollment: 70
• Locations: 6
• Arms: 2
• Duration (Months): 1
• Patients Per Site: 11.7
• Patients Per Site Per Month: 11.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the relative performance of a new daily disposable toric soft contact lens against a daily disposable toric contact lens currently available in market, specifically with regards to the comfort and vision with the lens.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Etafilcon A toric contact lens; Device: Nelfilcon A toric contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: Etafilcon A toric contact lens/Nelfilcon A toric Etafilcon A toric contact lens first, then nelfilcon A toric second	Device: Etafilcon A toric contact lens; contact lens to correct astigmatism; Device: Nelfilcon A toric contact lens; contact lens to correct astigmatism
Other: Nelfilcon A toric/ Etafilcon A toric Nelfilcon A toric contact lens first, then etafilcon A toric toric second	Device: Etafilcon A toric contact lens; contact lens to correct astigmatism; Device: Nelfilcon A toric contact lens; contact lens to correct astigmatism

Outcome Measures

Primary Outcome Measures

1. Monocular Visual Acuity on LogMAR Scale [After 5 to 9 days of lens wear]

   Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.

2. Binocular Visual Acuity on LogMAR Scale [After 5 to 9 days of lens wear]

   Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.

3. Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire [After 5 to 9 days of lens wear]

   The Contact Lens User Evaluation(CLUE)TM questionnaire 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 +/-3*SD).

4. Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire. [After 5 to 9 days of lens wear]

   The Contact Lens User Evaluation(CLUE)TM questionnaire 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 +/-3*SD).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The subject must be between 18 and 40 years old.

• The subject must have normal eyes.

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

• The subject must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form.

• The subject must have a subjective distance spectacle prescription in the range of -1.75 to -5.00D in each eye.

• The subject must manifest -1.25 to -2.00 D of refractive astigmatism in each eye.

• The subject's refractive cylinder axis must be 180 degrees plus or minus 30 degrees in each eye.

• The subject must be an adapted wearer of soft toric contact lenses in both eyes.

• The subject's best visual acuity (BVA) must be better than or equal to 20/25 in each eye.

• Subjects must already possess a wearable pair of spectacles.

Exclusion Criteria:

• Ocular or systemic allergies or disease that may interfere with contact lens wear.

• Systemic disease or autoimmune disease or use of medication, which may interfere with contact lens wear.

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

• Clinically significant (grade 3 or 4) tarsal abnormalities that 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

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

• Diabetes

• Strabismus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Los Angeles	California	United States	90049
2		Jacksonville	Florida	United States	32205
3		Jacksonville	Florida	United States	32256
4		Marietta	Georgia	United States	30060
5		New York	New York	United States	10001
6		Warwick	Rhode Island	United States	02886

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: NCT01055132
• Other Study ID Numbers: CR-1476AG
• First Posted: Jan 25, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Pre-assignment Detail	One subject failed screening, and did not enter group assignment

Arm/Group Title	Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second	Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second
Arm/Group Description	Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days	Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
Period Title: Period 1 (5-9 Days)
STARTED	36	33
COMPLETED	35	33
NOT COMPLETED	1	0
Period Title: Period 1 (5-9 Days)
STARTED	35	33
COMPLETED	35	32
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects who completed the study.
Overall Participants	69
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.1 (5.27)
Sex: Female, Male (Count of Participants)
Female	45 65.2%
Male	24 34.8%
Region of Enrollment (participants) [Number]
United States	69 100%

Outcome Measures

1. Primary Outcome

Title	Monocular Visual Acuity on LogMAR Scale
Description	Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Time Frame	After 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully complete the study.

Arm/Group Title	Etafilcon A Toric (Test Lens)	Nelfilcon A Toric (Active Comparator)
Arm/Group Description	Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days	An existing, daily disposable toric contact lens; worn 5-9 days
Measure Participants	67	67
Mean (Standard Deviation) [logMAR]	-0.065 (0.0777)	-0.038 (0.1057)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A Toric (Test Lens), Nelfilcon A Toric (Active Comparator)
	Comments	Ho:The test lens is non-inferior to the active comparator lens for monocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Based on historical data, a minimum of 42 subjects is needed to achieve 80% power with 0.05 type I error.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least-square mean difference
	Estimated Value	-0.037
	Confidence Interval	(2-Sided) 95%; -0.041 to -0.0013
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0072
	Estimation Comments	Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference(test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.

2. Primary Outcome

Title	Binocular Visual Acuity on LogMAR Scale
Description	Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice binocularly. Distance (4 meter) high contrast standard resolution (ETDRS) acuity was measured twice for each eye. Visual acuity describes the acuteness or sharpness of vision; the ability to perceive small details. Visual acuity is a measure of spacial resolution of the visual processing system; it's tested by requiring the person being tested to identify characters (like letters and numbers)on a chart from a set distance. LogMAR charts are used to assess visual acuity for research studies. LogMAR means Minimum Angle of Resolution. This has lead to the assertion that research is done using a logarithmic progression in size of letters on a test chart gives the most accurate visual acuity measurement. The reason for this is, unlike other charts, LogMAR chart has equal gradation between the letters on the line and the space between the lines. And, there is a fixed number of letters per line.
Time Frame	After 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully complete the study.

Arm/Group Title	Etafilcon A Toric (Test Lens)	Nelfilcon A Toric Lens (Active Comparator)
Arm/Group Description	Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days	An existing, daily disposable toric contact lens; worn 5-9 days
Measure Participants	67	67
Mean (Standard Deviation) [LogMAR]	-0.122 (0.0718)	-0.108 (0.0766)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A Toric (Test Lens), Nelfilcon A Toric (Active Comparator)
	Comments	Ho:The test lens is non-inferior to the active comparator lens for Binocular visual performance on logMAR scale at 1-week follow-up. A non-inferiority margin of 0.05 logMAR was used.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least-square mean difference
	Estimated Value	-0.015
	Confidence Interval	(2-Sided) 95%; -0.027 to -0.003
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0062
	Estimation Comments	Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the upper limit of the confidence limit is below 0.05 LogMAR.

3. Primary Outcome

Title	Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE)TM Questionnaire
Description	The Contact Lens User Evaluation(CLUE)TM questionnaire 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 +/-3*SD).
Time Frame	After 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully complete the study.

Arm/Group Title	Etafilcon A (Test Lens)	Nelfilcon A (Active Comparator)
Arm/Group Description	Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn 5-9 days	An existing, daily disposable toric contact lens; worn for 5-9 days
Measure Participants	67	67
Mean (Standard Deviation) [units on a scale]	56.4 (9.12)	44.0 (9.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A Toric (Test Lens), Nelfilcon A Toric (Active Comparator)
	Comments	Ho:The test lens is non-inferior to the active comparator lens for comfort at 1-week follow-up. A non-inferiority margin of -5 units was used.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least-square mean difference
	Estimated Value	11.9
	Confidence Interval	(2-Sided) 95%; 4.05 to 19.79
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.93
	Estimation Comments	Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.

4. Primary Outcome

Title	Subject Reported Overall Quality of Vision Using the Contact Lens User Evaluation(CLUE)TM Questionnaire.
Description	The Contact Lens User Evaluation(CLUE)TM questionnaire 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 +/-3*SD).
Time Frame	After 5 to 9 days of lens wear

Outcome Measure Data

Analysis Population Description

Analysis was conducted on subjects who successfully complete the study.

Arm/Group Title	Etafilcon A (Test Lens)	Nelfilcon A (Active Comparator)
Arm/Group Description	Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days	An existing, daily disposable toric contact lens; worn for 5-9 days.
Measure Participants	67	67
Mean (Standard Deviation) [units on a scale]	52.7 (8.64)	44.7 (9.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A Toric (Test Lens), Nelfilcon A Toric (Active Comparator)
	Comments	Ho:The test lens is non-inferior to the active comparator lens for overall quality of vision at 1-week follow-up. A non-inferiority margin of -5 units was used.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Based on historical data, a minimum of 42 subjects is needed to achieve a minimum of 80% power with 0.05 type I error.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	least-square mean difference
	Estimated Value	7.7
	Confidence Interval	(2-Sided) 95%; 0.58 to 14.80
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 3.55
	Estimation Comments	Comparison between study lenses was carried out using 2-sided 95% confidence interval of the least-square mean difference (test minus control). The non-inferiority was concluded if the lower limit of the confidence interval is higher than -5.

Adverse Events

Arm/Group Title	Etafilcon A Toric / Nelfilcon A Toric
Arm/Group Description	etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days
All Cause Mortality
	Etafilcon A Toric / Nelfilcon A Toric
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Etafilcon A Toric / Nelfilcon A Toric
	Affected / at Risk (%)	# Events
Total	0/69 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A Toric / Nelfilcon A Toric
	Affected / at Risk (%)	# Events
Total	0/69 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publications require agreement and written approval from Sponsor.