Two Week Cross-Over Study Comparing Two Daily Disposable Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01155323
• Collaborator: Johnson & Johnson K.K. Medical Company (Industry), Visioncare Research Ltd. (Other)
• Enrollment: 118
• Location: 1
• Arms: 2
• Actual Duration (Months): 3
• Patients Per Site Per Month: 39

Study Details

Study Description

Brief Summary

This study seeks to evaluate and compare the clinical performance of two daily disposable soft contact lenses, Proclear 1 Day and 1-Day Acuvue Moist.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: etafilcon A; Device: omafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Proclear 1 Day Lens vs 1-Day Acuvue Moist Daily Disposable Contact Lens Crossover Study
• Actual Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: etafilcon A/omafilcon A etafilcon A contact lenses will be worn during the first week and omafilcon A contact lenses will be worn during the second. Lenses were replaced daily	Device: etafilcon A; 1-day soft contact lens; Device: omafilcon A; 1-day soft contact lens
Active Comparator: omafilcon A/etafilcon A omafilcon A contact lenses will be worn during the first week and etafilcon A contact lenses will be worn during the second. Lenses were replaced daily.	Device: etafilcon A; 1-day soft contact lens; Device: omafilcon A; 1-day soft contact lens

Outcome Measures

Primary Outcome Measures

1. Subjective Rating of Comfort [after 1 week of lens wear]

   This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

2. Vision Quality [after 1 week of lens wear]

   This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

3. Subjective Rating of Handling [after 1 week of lens wear]

   This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

4. Corneal Staining [after 1 week of lens wear]

   Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.

5. Subjective Rating of Quality Perceptions [after 1 week of lens wear]

   This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.

6. Limbal Hyperemia [after 1 week of wear]

   This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• At least 18 years of age and no more than 39 years of age

• Existing soft contact lens wearers

• Willing to signed a written Informed Consent.

• Own a mobile phone and are willing to receive and reply to Short Message Service (SMS) messages during the day.

• Have a contact lens spherical distance requirement between -1.00 diopters (D) and -6.00 diopters (D) in both eyes.

• Have an Astigmatism of 1.00D or less in both eyes.

• Require a visual correction in both eyes.

• Be correctable to a visual acuity of 6/9 (20/30) or better in each eye.

• Have normal eyes with no evidence of abnormality or disease that would preclude lens wear.

Exclusion Criteria:

• Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, tarsal abnormalities, bulbar infection, or any other abnormality of the cornea that would contraindicate contact lens wear.

• Clinically significant corneal staining (Grade 3 in more than one region).

• Keratoconus or other corneal irregularity.

• Abnormal lachrymal secretions.

• Extended wear of contact lenses last 3 months.

• Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in the previous 8 weeks.

• Refractive surgery.

• Eye injury/surgery within 8 weeks immediately prior to enrollment for this study.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Require concurrent ocular medication

• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.

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

• Diabetes.

• Pregnant, lactating or planning a pregnancy at the time of enrollment.

• Participation in any concurrent clinical trial or in last 30 days.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Singapore Plytechnic	Singapore		Singapore	139651

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Johnson & Johnson K.K. Medical Company
• Visioncare Research Ltd.

Investigators

• Principal Investigator: Danny Sim, Diploma in Optometry, Singapore Polytechnic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT01155323
• Other Study ID Numbers: CR-0926; DISP-523
• First Posted: Jul 1, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Etafilcon A/Omafilcon A	Omafilcon A/Etafilcon A
Arm/Group Description	etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.	omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
Period Title: First Intervention
STARTED	60	58
COMPLETED	59	57
NOT COMPLETED	1	1
Period Title: First Intervention
STARTED	59	57
COMPLETED	58	56
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Total Number of Participants
Arm/Group Description	This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
Overall Participants	113
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.3 (4.4)
Sex: Female, Male (Count of Participants)
Female	80 70.8%
Male	33 29.2%
Region of Enrollment (participants) [Number]
Singapore	113 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Rating of Comfort
Description	This outcome is a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear

Outcome Measure Data

Analysis Population Description

The analysis population represents subjects that completed the study per protocol.

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description	soft contact lens replaced daily, worn for one week.	soft contact lens replaced daily, worn for one week.
Measure Participants	113	113
Least Squares Mean (Standard Error) [Units on a scale]	3.33 (0.09)	3.32 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments	The alternative hypothesis was that etafilcon A would be superior to omafilcon A for comfort.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 95%; -0.21 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments	Mean difference is calculated as etafilcon A minus omafilcon A.

2. Primary Outcome

Title	Vision Quality
Description	This outcome is a weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear

Outcome Measure Data

Analysis Population Description

The analysis population represents subjects that completed the study per protocol.

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description	soft contact lens replaced daily, worn for one week.	soft contact lens replaced daily, worn for one week.
Measure Participants	113	113
Least Squares Mean (Standard Error) [Units on a scale]	3.53 (0.08)	3.50 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments	The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for vision.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = -0.50
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -0.19 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments	The mean difference is calculated as etafilcon A minus omafilcon A.

3. Primary Outcome

Title	Subjective Rating of Handling
Description	This outcome is a weighted combined score calculated from individual lens handling-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear

Outcome Measure Data

Analysis Population Description

The analysis population represents subjects that completed the study per protocol.

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description	soft contact lens replaced daily, worn for one week.	soft contact lens replaced daily, worn for one week.
Measure Participants	113	113
Least Squares Mean (Standard Error) [Units on a scale]	3.48 (0.09)	3.48 (0.09)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments	The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for lens handling.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = -0.50
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -0.22 to 0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments	The mean difference is calculated as etafilcon A minus omafilcon A.

4. Primary Outcome

Title	Corneal Staining
Description	Investigator assessment of the corneal staining. Staining is an indication of dryness on areas on the cornea. Here it is measured over 5 regions of the cornea: central, temporal, nasal, inferior, and superior. The staining is graded using the National Eye Institute (NEI)0-3 scale: grade 0 = normal, grade 1 = mild, grade 2 = moderate, grade 3 = severe.
Time Frame	after 1 week of lens wear

Outcome Measure Data

Analysis Population Description

The analysis population represents subjects that completed the study per protocol.

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description	soft contact lens replaced daily, worn for one week.	soft contact lens replaced daily, worn for one week.
Measure Participants	113	113
Least Squares Mean (Standard Error) [Units on a scale]	0.07 (0.01)	0.09 (0.01)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments	The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A for corneal staining.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Margin = +/-0.50
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.01
	Estimation Comments	The mean difference is calculated as etafilcon A minus omafilcon A.

5. Primary Outcome

Title	Subjective Rating of Quality Perceptions
Description	This outcome is a weighted combined score calculated from individual quality perception-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response.
Time Frame	after 1 week of lens wear

Outcome Measure Data

Analysis Population Description

The analysis population represents subjects that completed the study per protocol.

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description	soft contact lens replaced daily, worn for one week.	soft contact lens replaced daily, worn for one week.
Measure Participants	113	113
Least Squares Mean (Standard Error) [Units on a scale]	3.51 (0.08)	3.44 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments	The alternative hypothesis was that etafilcon A would be non-inferior to omafilcon A for quality perceptions.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Non-inferiority margin = -0.50
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 95%; -0.15 to 0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments	The mean difference is calculated as etafilcon A minus omafilcon A.

6. Primary Outcome

Title	Limbal Hyperemia
Description	This outcome is assessed by the investigator during biomicroscopy examination using the following 0-4 scale: 0 = none, 1 = trace, 2 = mild, 3= moderate, 4 = severe.
Time Frame	after 1 week of wear

Outcome Measure Data

Analysis Population Description

The analysis population represents subjects that completed the study per protocol.

Arm/Group Title	Etafilcon A	Omafilcon A
Arm/Group Description	soft contact lens replaced daily, worn for one week.	soft contact lens replaced daily, worn for one week.
Measure Participants	113	113
Least Squares Mean (Standard Error) [Units on a scale]	0.51 (0.02)	0.48 (0.02)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Etafilcon A, Omafilcon A
	Comments	The alternative hypothesis was that etafilcon A would be equivalent to omafilcon A from limbal hyperemia.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Margin = +/- 0.50
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 95%; -0.01 to 0.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02
	Estimation Comments	The mean difference is calculated as etafilcon A minus omafilcon A.

Adverse Events

Arm/Group Title	Etafilcon A		Omafilcon A
Arm/Group Description	soft contact lens replaced daily, worn for one week.		soft contact lens replaced daily, worn for one week.
All Cause Mortality
	Etafilcon A		Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A		Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/116 (0%)		0/116 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A		Omafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/116 (0%)		0/116 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The results of the study may not be published or publicly presented without prior written approval of the sponsor. If the investigator wishes to publish or present any study findings, investigator shall contact sponsor to discuss publication plan.