A Comparison of Two Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00700752
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 20

Study Details

Study Description

Brief Summary

This study seeks to evaluate the clinical and subjective performance of two established soft contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia	Device: senofilcon A; Device: balafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: May 1, 2008
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: senofilcon A/balafilcon A senofilcon A silicone hydrogel contact lens worn during first 4-week period, balafilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.	Device: senofilcon A; silicone hydrogel contact lens; Device: balafilcon A; silicone hydrogel contact lens
Active Comparator: balafilcon A/senofilcon A balafilcon A silicone hydrogel contact lens worn worn during first 4-week period, senofilcon A silicone hydrogel contact lens worn during the second 4-week period. Senofilcon A lenses worn daily on a 2-week replacement schedule; balafilcon A lenses worn daily on a 4-week replacement schedule. Lens replacement conducted in-office in a masked process.	Device: senofilcon A; silicone hydrogel contact lens; Device: balafilcon A; silicone hydrogel contact lens

Outcome Measures

Primary Outcome Measures

1. Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A). [after 4 weeks of lens wear]

   Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. They are of legal age (18 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	Indiana University	Bloomington	Indiana	United States	47405

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: NCT00700752
• Other Study ID Numbers: CR-0728
• First Posted: Jun 19, 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	Senofilcon A/Balafilcon A	Balafilcon A/Senofilcon A
Arm/Group Description	senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.	balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
Period Title: First Intervention
STARTED	20	20
COMPLETED	20	18
NOT COMPLETED	0	2
Period Title: First Intervention
STARTED	20	18
COMPLETED	20	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Completed study population
Overall Participants	38
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	24.4 (3.4)
Sex: Female, Male (Count of Participants)
Female	29 76.3%
Male	9 23.7%
Region of Enrollment (participants) [Number]
United States	38 100%

Outcome Measures

1. Primary Outcome

Title	Patient-reported Comfort at at the Manufacturer's Recommended Lens Replacement Timeframe of 2-weeks (Senofilcon A) or 4-weeks (Balafilcon A).
Description	Subjective rating of overall comfort using a 0 through 5 scale. 0=n/a, 1=poor, 2=fair, 3=good, 4=very good, 5=excellent. Scores from 2-week and 4-week visits were combined for final values.
Time Frame	after 4 weeks of lens wear

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Senofilcon A	Balafilcon A
Arm/Group Description	silicone hydrogel contact lens worn daily with a 2-week replacement regimen.	silicone hydrogel contact lens worn daily with a 4-week replacement regimen
Measure Participants	38	38
Least Squares Mean (Standard Error) [Units on a scale]	4.0074 (0.2008)	2.8438 (0.1972)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Senofilcon A, Balafilcon A
	Comments	Alternative hypothesis is senofilcon A is superior to balafilcon 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	1.1636
	Confidence Interval	(2-Sided) 95%; 0.7890 to 1.1636
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.1887
	Estimation Comments	The mean difference is calculated as senofilcon A minus balafilcon A.

Adverse Events

Arm/Group Title	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
Arm/Group Description	senofilcon A silicone hydrogel contact lens worn first, balafilcon A silicone hydrogel contact lens worn second.		balafilcon A silicone hydrogel contact lens worn first, senofilcon A silicone hydrogel contact lens worn second.
All Cause Mortality
	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon A/Balafilcon A		Balafilcon A/Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (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.