A Comparison of Two Daily Disposable Contact Lenses.

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00721500
• Collaborator: Visioncare Research Ltd. (Other)
• Enrollment: 25
• Location: 1
• Arms: 4
• Duration (Days): 30
• Patients Per Site Per Month: 25.4

Study Details

Study Description

Brief Summary

This study seeks to evaluate the clinical fitting performance of a new daily disposable contact lens to an existing daily disposable contact lens.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Myopia	Device: etafilcon A; Device: narafilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Evaluation of the Lens Fit of Narafilcon A Soft Contact Lenses
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: narafilcon A / etafilcon A - etafilcon A - narafilcon A First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist ; Device: narafilcon A; contact lens; Other Names: TruEye
Experimental: narafilcon A / etafilcon A - narafilcon A - etafilcon A First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist ; Device: narafilcon A; contact lens; Other Names: TruEye
Experimental: narafilcon A - etafilcon A - narafilcon A / etafilcon A First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist ; Device: narafilcon A; contact lens; Other Names: TruEye
Experimental: etafilcon A - narafilcon A - narafilcon A / etafilcon A First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.	Device: etafilcon A; contact lens; Other Names: 1-Day Acuvue Moist ; Device: narafilcon A; contact lens; Other Names: TruEye

Outcome Measures

Primary Outcome Measures

1. Proportion of Eyes Successfully Fit [Within 20 minutes of lens insertion]

   Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.

2. Lens Fit Decentration [Within 20 minutes of lens insertion]

   Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.

3. Lens Tightness on Cornea With Manual Digit Push Up [Within 20 minutes of lens insertion]

   Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• They are of legal age (18 years) and capacity to volunteer.

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

• They are willing and able to follow the protocol.

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

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

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

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

Exclusion Criteria:

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

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

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

• They are aphakic.

• They have had corneal refractive surgery.

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

• They are pregnant or lactating.

• 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.

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

• They have diabetes.

• 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	Visioncare Research Ltd	Farnham	Surrey	United Kingdom	GU9 7EN

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Visioncare Research Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00721500
• Other Study ID Numbers: CR-0812; PROD-502
• First Posted: Jul 24, 2008
• Last Update Posted: May 21, 2015
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	There were 25 subjects enrolled to the study.
Pre-assignment Detail	Subjects were enrolled per inclusion/exclusion criteria and randomized to a study arm.

Arm/Group Title	Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A	Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A	Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A	Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
Arm/Group Description	First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.	First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.	First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.	First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
Period Title: Period One
STARTED	6	7	6	6
COMPLETED	6	7	6	6
NOT COMPLETED	0	0	0	0
Period Title: Period One
STARTED	6	7	6	6
COMPLETED	6	7	6	6
NOT COMPLETED	0	0	0	0
Period Title: Period One
STARTED	6	7	6	6
COMPLETED	6	7	6	6
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Subjects
Arm/Group Description	All subjects who enrolled and completed study.
Overall Participants	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.9 (11.9)
Sex: Female, Male (Count of Participants)
Female	17 68%
Male	8 32%
Region of Enrollment (participants) [Number]
United Kingdom	25 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Eyes Successfully Fit
Description	Overall lens fit acceptance was assessed by the Investigator based on lens fit alone in a 6-level scale; 0=should not be worn, 1=should not be dispensed although no immediate danger, 2=borderline but unacceptable, 3=minimal acceptable, early review, 4=not perfect but OK to dispense and 5=perfect. Lens fitting responses >2 were considered 'successful fit' while the rest of responses were considered 'unsuccessful fit'.
Time Frame	Within 20 minutes of lens insertion

Outcome Measure Data

Analysis Population Description

Participants who were enrolled and completed the study.

Arm/Group Title	Narafilcon A (Bilateral)	Narafilcon A (Contralateral)	Etafilcon A (Bilateral)	Etafilcon A (Contralateral)
Arm/Group Description	narafilcon A contact lens worn in both eyes.	Narafilcon A worn in either eye.	Etafilcon A contact lens worn in both eyes.	Etafilcon A worn in either eye.
Measure Participants	25	25	25	25
Measure eyes	50	25	50	25
Number [proportion of participant eyes]	0.98	0.96	0.96	0.96

2. Primary Outcome

Title	Lens Fit Decentration
Description	Lens centration was assessed in primary gaze, diffuse white light, low-medium magnification, with graticule. Lens fit decentration with respect to visible cornea was measured to nearest 0.1mm.
Time Frame	Within 20 minutes of lens insertion

Outcome Measure Data

Analysis Population Description

Participants who were enrolled and completed the study.

Arm/Group Title	Narafilcon A	Narafilcon A (Contralateral)	Etafilcon A (Bilateral)	Etafilcon A (Contralateral)
Arm/Group Description	Narafilcon A contact lens worn in both eyes.	Narafilcon A worn in either eye.	Etafilcon A contact lens worn in both eyes.	Etafilcon A worn in either eye.
Measure Participants	25	25	25	25
Measure eye	50	25	50	25
Mean (Standard Deviation) [mm]	0.25 (0.14)	0.22 (0.16)	0.27 (0.17)	0.27 (0.15)

3. Primary Outcome

Title	Lens Tightness on Cornea With Manual Digit Push Up
Description	Lens tightness on push-up assessed by digital push-up test (gentle push of the lens upward using the lower lid) with eye in primary gaze position and observing ease of push-up and speed of return to original position. Tightness is measured on a 0%-100% continuous scale where 0%=falls from cornea without lid support, 50%=optimum and 100%=no movement.
Time Frame	Within 20 minutes of lens insertion

Outcome Measure Data

Analysis Population Description

Participants who were enrolled and completed the study.

Arm/Group Title	Narafilcon A (Bilateral)	Narafilcon A (Contralateral)	Etafilcon A (Bilateral)	Etafilcon A (Contralateral)
Arm/Group Description	Narafilcon A contact lens worn in both eyes.	Narafilcon A worn in either eye.	Etafilcon A contact lens worn in both eyes.	Etafilcon A worn in either eye.
Measure Participants	25	25	25	25
Measure eye	50	25	50	25
Mean (Standard Deviation) [percentage]	44.6 (6.3)	46.9 (5.5)	56.3 (8.6)	58.1 (7.8)

Adverse Events

Arm/Group Title	Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A		Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A		Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A		Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
Arm/Group Description	First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A contact lenses worn in both eyes.		First, narafilcon A and etafilcon A contact lenses worn contralaterally. Second, narafilcon A contact lenses worn in both eyes. Third, etafilcon A contact lenses worn in both eyes.		First, narafilcon A contact lenses worn in both eyes. Second, etafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.		First, etafilcon A contact lenses worn in both eyes. Second, narafilcon A contact lenses worn in both eyes. Third, narafilcon A and etafilcon A contact lenses worn contralaterally.
All Cause Mortality
	Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A		Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A		Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A		Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A		Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A		Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A		Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)		0/4 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Narafilcon A/Etafilcon A - Etafilcon A - Narafilcon A		Narafilcon A/Etafilcon A - Narafilcon A - Etafilcon A		Narafilcon A - Etafilcon A - Narafilcon A/Etafilcon A		Etafilcon A - Narafilcon A - Narafilcon A/Etafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)		0/4 (0%)		0/2 (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.