Clinical Performance of a New Daily Disposable Contact Lens Worn in an Established Contact Lens Wearing Population

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00708643
• Collaborator: University of Manchester (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 26.5

Study Details

Study Description

Brief Summary

This study seeks to evaluate the clinical and subjective performance of a new daily disposable soft contact lens.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia	Device: Habitual Silicone Hydrogel Contact Lens; Device: narafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Habitual silicone hydrogel Habitual contact lens wear.	Device: Habitual Silicone Hydrogel Contact Lens; contact lens
Experimental: narafilcon A Silicone hydrogel daily disposable contact lens	Device: narafilcon A; contact lens

Outcome Measures

Primary Outcome Measures

1. Limbal Hyperemia [At 2 weeks and 4 weeks]

   Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.

2. Lens Comfort [At 3,7,10,13,17,21,24, and 27 days]

   Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.

3. Upper Lid Margin Staining [At 2 weeks and 4 weeks.]

   Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.

Secondary Outcome Measures

1. Tarsal Roughness [At 2 weeks and 4 weeks]

   Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.

2. Tarsal Hyperemia [At 2 weeks and 4 weeks.]

   Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.

3. Corneal Staining [At 2 weeks and 4 weeks.]

   A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. They are of legal age (17 years) and capacity to volunteer.

2. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They would be expected to attain at least 6/9 (20/30) in each eye with the study lenses.

5. They are able to wear contact lenses with a back vertex power of -1.00 to -6.00DS.

6. They have a maximum of 1.00D of refractive astigmatism (i.e. ≤ 1.00 DC).

7. They have successfully worn contact lenses within six months of starting the study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They are aphakic.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.

7. They are pregnant or lactating.

8. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

9. They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV).

10. They have diabetes.

11. They have taken part in any other clinical trial or research, within two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Contact Lens Research	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• University of Manchester

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00708643
• Other Study ID Numbers: CR-0803
• First Posted: Jul 2, 2008
• Last Update Posted: May 21, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens
Period Title: Overall Study
STARTED	40	40
COMPLETED	40	39
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A	Total
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens	Total of all reporting groups
Overall Participants	40	40	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.3 (9.9)	25.8 (8.7)	27.2 (9.6)
Gender (participants) [Number]
Female	32 80%	33 82.5%	65 81.3%
Male	8 20%	6 15%	14 17.5%
Region of Enrollment (participants) [Number]
Canada	40 100%	39 97.5%	79 98.8%

Outcome Measures

1. Primary Outcome

Title	Limbal Hyperemia
Description	Measures the redness of the limbal region of the eye on a scale of 0 to 100 grade with 0=none and 100=severe. The analysis is the average grade over all time frames.
Time Frame	At 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description

The analysis includes all subjects that completed the study.

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens
Measure Participants	40	39
Least Squares Mean (Standard Error) [units on a scale]	34.0967 (1.4982)	31.0920 (1.7271)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Habitual Silicone Hydrogel, Narafilcon A
	Comments	The alternative hypothesis is that narafilcon A will provide a lower level of limbal hyperemia than the habitual lens.
	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	-3.0047
	Confidence Interval	(2-Sided) 98.75%; -3.0047 to 2.7153
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.2863
	Estimation Comments	The mean difference is calculated as narafilcon A minus the habitual lens.

2. Primary Outcome

Title	Lens Comfort
Description	Rating of lens comfort by rating agreement to the following statement: "The lenses I am wearing are comfortable." Rating using the following scale: 1=strongly agree, 2=agree, 3=neutral, 4=disagree, 5=strongly disagree. The rating is averaged over all time frames.
Time Frame	At 3,7,10,13,17,21,24, and 27 days

Outcome Measure Data

Analysis Population Description

The analysis includes all subjects that completed the study.

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens
Measure Participants	40	39
Least Squares Mean (Standard Error) [units on a scale]	1.1078 (0.4993)	1.0274 (0.5737)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Habitual Silicone Hydrogel, Narafilcon A
	Comments	The alternative hypothesis is that narafilcon A provides better comfort than the habitual lens by having a lower rating on the scale.
	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	-0.0804
	Confidence Interval	(2-Sided) 99%; -0.0804 to 1.8821
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.7605
	Estimation Comments	The mean difference is calculated as narafilcon A minus habitual lens.

3. Primary Outcome

Title	Upper Lid Margin Staining
Description	Measures the trauma to tissue that lines the margin of the inside of the upper eyelid on a 0 to 3 scale, with 0=none to 3=severe. The analysis is the average grade over all time frames.
Time Frame	At 2 weeks and 4 weeks.

Outcome Measure Data

Analysis Population Description

The analysis includes all subjects that completed the study.

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens
Measure Participants	40	39
Least Squares Mean (Standard Error) [units on a scale.]	0.9358 (1.1146)	1.1586 (1.2857)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Habitual Silicone Hydrogel, Narafilcon A
	Comments	The alternative hypothesis is that narafilcon A provides a lowe level of upper lid margin staining than the habitual lens.
	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	0.2228
	Confidence Interval	(2-Sided) 99%; 0.2228 to 4.6564
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.7002
	Estimation Comments	The mean difference is calculated as narafilcon A minus the habitual lens.

4. Secondary Outcome

Title	Tarsal Roughness
Description	Measures the amount of roughness to the tissue of the inside upper and lower eyelid on a scale of 0 to 100 with 0=none and 100=severe. The analysis is the average grade over all time frames.
Time Frame	At 2 weeks and 4 weeks

Outcome Measure Data

Analysis Population Description

The analysis includes all subjects that completed the study.

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens
Measure Participants	40	39
Least Squares Mean (Standard Error) [units on a scale]	30.1028 (0.7784)	31.3624 (0.8994)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Habitual Silicone Hydrogel, Narafilcon A
	Comments
	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	1.2596
	Confidence Interval	(2-Sided) 98.75%; 1.2596 to 4.2599
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.1873
	Estimation Comments	The mean difference is calculated as narafilcon A minus the habitual lens.

5. Secondary Outcome

Title	Tarsal Hyperemia
Description	Measures the amount of redness to the tissue of the inside upper and lower eyelid using a 0 to 100 scale with 0=none and 100=severe.
Time Frame	At 2 weeks and 4 weeks.

Outcome Measure Data

Analysis Population Description

The analysis includes all subjects that completed the study.

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens
Measure Participants	40	39
Least Squares Mean (Standard Error) [units on a scale]	38.4103 (1.5238)	37.5478 (1.7646)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Habitual Silicone Hydrogel, Narafilcon A
	Comments	The alternative hypothesis is that narafilcon A provides a lower level of tarsal hyperemia than the habitual lens.
	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	-0.8625
	Confidence Interval	(2-Sided) 98.75%; -0.8625 to 5.0524
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.3407
	Estimation Comments	The mean difference is calculated as narafilcon A minus habitual lens.

6. Secondary Outcome

Title	Corneal Staining
Description	A measure of corneal abrasion using a 0 to 100 scale with 0=none, 25=micropunctate, 50=macropunctate, 75=coalescence, 100=patch. The analysis is the average grade over all time frames.
Time Frame	At 2 weeks and 4 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Habitual Silicone Hydrogel	Narafilcon A
Arm/Group Description	Habitual contact lens wear.	Silicone hydrogel daily disposable contact lens
Measure Participants	40	39
Least Squares Mean (Standard Error) [units on a scale]	6.6173 (1.1106)	6.3763 (1.2820)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Habitual Silicone Hydrogel, Narafilcon A
	Comments	The alternative hypothesis is that narafilcon A provides lower levels of corneal staining than the habitual lens.
	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	-0.2410
	Confidence Interval	(2-Sided) 98.75%; -0.2410 to 4.0043
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.6975
	Estimation Comments	The mean difference is calculated as narafilcon A minus habitual lens.

Adverse Events

Arm/Group Title	Habitual Silicone Hydrogel		Narafilcon A
Arm/Group Description	Habitual contact lens wear.		Silicone hydrogel daily disposable contact lens
All Cause Mortality
	Habitual Silicone Hydrogel		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Habitual Silicone Hydrogel		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)
Other (Not Including Serious) Adverse Events
	Habitual Silicone Hydrogel		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/40 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.