Dispensing Evaluation of New Daily Disposable Toric Soft Contact Lens.

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition	Astigmatism
Interventions	Device: Etafilcon A toric contact lens; Device: Nelfilcon A toric contact lens
Enrollment	70

Participant Flow

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Recruitment Details
Pre-assignment Details	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
Reason Not Completed
unsatisfactory lens fitting performance	1	0
Period Title: Period 2 (5-9 Days)
Started	35	33
Completed	35	32
Not Completed	0	1
Reason Not Completed
Unsatisfactory lens fitting performance	0	1

Baseline Characteristics

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Arm/Group Title		All Subjects
Arm/Group Description		All subjects who completed the study.
Overall Number of Baseline Participants		69
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	69 participants
		29.1 (5.27)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	69 participants
	Female	45 65.2%
	Male	24 34.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	69 participants
		69

Outcome Measures

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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
Overall Number of Participants Analyzed	67	67
Mean (Standard Deviation); Unit of Measure: 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	[Not Specified]
	Comments	[Not Specified]
	Method	linear mixed model
	Comments	Sequence of wear, period and lens were included as fixed effects; site, patient, eye*patient, period*patient and period*eye*patient as random effects.
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
Overall Number of Participants Analyzed	67	67
Mean (Standard Deviation); Unit of Measure: 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 Lens (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	[Not Specified]
	Comments	[Not Specified]
	Method	linear mixed model
	Comments	Sequence of wear,lens period and lens were included in the model as fixed effects; site, patient, period*patient were included as random effects.
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
Overall Number of Participants Analyzed	67	67
Mean (Standard Deviation); Unit of Measure: units on a scale
	56.4 (9.12)	44.0 (9.34)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A (Test Lens), Nelfilcon A (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	[Not Specified]
	Comments	[Not Specified]
	Method	linear mixed model
	Comments	Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and Site and patient as random effects.
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.
Overall Number of Participants Analyzed	67	67
Mean (Standard Deviation); Unit of Measure: units on a scale
	52.7 (8.64)	44.7 (9.41)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A (Test Lens), Nelfilcon A (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	[Not Specified]
	Comments	[Not Specified]
	Method	linear mixed model
	Comments	Sequence of lens wear, lens period and lens type were included in the model as fixed effects; and site and patient as random effects.
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

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Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
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 (%)
Total	--/--
Serious Adverse Events
	Etafilcon A Toric / Nelfilcon A Toric
	Affected / at Risk (%)
Total	0/69 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Etafilcon A Toric / Nelfilcon A Toric
	Affected / at Risk (%)
Total	0/69 (0.00%)

Limitations and Caveats

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[Not Specified]

More Information

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Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Publications require agreement and written approval from Sponsor.

Results Point of Contact

Name/Title: Ross Franklin

Organization: Johnson & Johnson Vision Care

Phone: 1-904-443-1379

EMail: RFrankl1@its.jnj.com

Responsible Party:	Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:	NCT01055132 History of Changes
Other Study ID Numbers:	CR-1476AG
First Submitted:	January 22, 2010
First Posted:	January 25, 2010
Results First Submitted:	November 3, 2011
Results First Posted:	February 7, 2013
Last Update Posted:	June 19, 2018