Clinical Evaluation of Two Daily Disposable Contact Lenses

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01163760
• Collaborator: Singapore Polytechnic University (Other), Visioncare Research Ltd. (Other)
• Enrollment: 50
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

This study seeks to evaluate the clinical performance of two daily disposable contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: etafilcon A; Device: ocufilcon D	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Sep 1, 2007
• Actual Study Completion Date: Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: etafilcon A / ocufilcon D etafilcon A contact lens worn first daily disposable , ocufilcon D contact lens worn second daily disposable	Device: etafilcon A; daily disposable contact lens; Device: ocufilcon D; daily disposable contact lens
Other: oculfilcon D / etafilcon A ocufilcon D contact lens worn first, etafilcon A contact lens worn second	Device: etafilcon A; daily disposable contact lens; Device: ocufilcon D; daily disposable contact lens
Other: ocufilcon D / ocufilcon D ocufilcon D contact lens worn first and second	Device: ocufilcon D; daily disposable contact lens
Other: etafilcon A / etafilcon A etafilcon A contact lens worn first and second	Device: etafilcon A; daily disposable contact lens

Outcome Measures

Primary Outcome Measures

1. Lens Comfort [1-week follow-up]

   Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)

Secondary Outcome Measures

1. Comfort Throughout the Whole Day [1-week follow-up]

   Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

Other Outcome Measures

1. Comfort While Working on Computer [1-week-follow-up]

   Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Be between 21 and 39 years of age.

• Signed Written Informed Consent and Investigator to record this on Case Report Form (CRF) in appropriate space.

• Be existing (i.e. successfully worn for 1-month prior to the study) soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).

• Require a visual correction in both eyes (monovision allowed but no monofit).

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

• Astigmatism of 1.00D or less in both eyes.

• Be able to wear the lens powers available for this study.

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

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

• No amblyopia.

• No evidence of lid abnormality or infection.

• No conjunctival abnormality or infection.

• No clinically significant slit lamp findings (i.e. edema, staining, scarring, vascularisation, infiltrates or abnormal opacities).

• No other active ocular disease.

Exclusion Criteria:

• Requires concurrent ocular medication.

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

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

• Diabetic.

• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

• Extended lens wear in last 3 months.

• PMMA or RGP lens wear in the previous 8 weeks.

• Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.

• Abnormal lacrimal secretions.

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

• Keratoconus or other corneal irregularity.

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

• Participation in any concurrent clinical trial or in last 60 days."

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Singapore		Singapore

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Singapore Polytechnic University
• 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: NCT01163760
• Other Study ID Numbers: CR-0706; PRO-518
• First Posted: Jul 16, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Recruitment Details	There were 50 subjects enrolled in this single site study, located at Singapore University.
Pre-assignment Detail	There were 50 patients enrolled and randomized, and 50 patients completed the study.

Arm/Group Title	Etafilcon A First, Then Ocufilcon D	Ocufilcon D First, Then Etafilcon A	Etafilcon A First, Then Etafilcon A	Ocufilcon D First, Then Ocufilcon D
Arm/Group Description	etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second	ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.	etafilcon A contact lenses worn for both periods.	Ocufilcon D contact lenses worn for both periods.
Period Title: Period 1 (Fit)
STARTED	12	13	13	12
COMPLETED	12	13	13	12
NOT COMPLETED	0	0	0	0
Period Title: Period 1 (Fit)
STARTED	12	13	13	12
COMPLETED	12	13	13	12
NOT COMPLETED	0	0	0	0
Period Title: Period 1 (Fit)
STARTED	12	13	13	12
COMPLETED	12	13	13	12
NOT COMPLETED	0	0	0	0
Period Title: Period 1 (Fit)
STARTED	12	13	13	12
COMPLETED	12	13	13	12
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Total number of completed participants are included in baseline measurements.
Overall Participants	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25.0 (4.8)
Sex: Female, Male (Count of Participants)
Female	31 62%
Male	19 38%

Outcome Measures

1. Primary Outcome

Title	Lens Comfort
Description	Lens comfort was evaluated via the subjective question: "How comfortable did your eyes feel at the end of the day when wearing the contact lenses you were provided?" (excellent/very good=5...very good=3...Poor=0)
Time Frame	1-week follow-up

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those who were enrolled, randomized, and completed the study.

Arm/Group Title	Etafilcon A	Ocufilcon D
Arm/Group Description	etafilcon A contact lenses worn in either the first or second period.	ocufilcon D contact lenses worn in either the first or second period.
Measure Participants	51	49
Mean (Standard Deviation) [units on a scale]	3.08 (0.98)	3.00 (1.15)

2. Secondary Outcome

Title	Comfort Throughout the Whole Day
Description	Comfort throughout the day was evaluated via subjective question: "Comfort throughout the whole day" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Time Frame	1-week follow-up

Outcome Measure Data

Analysis Population Description

Subjects analyzed were those enrolled, randomized, and completed the study.

Arm/Group Title	Etafilcon A	Ocufilcon D
Arm/Group Description	etafilcon A contact lenses worn in either the first or second period.	ocufilcon D contact lenses worn in either the first or second period.
Measure Participants	51	49
Number [percentage of participants]	39.2 78.4%	36.7 NaN

3. Other Pre-specified Outcome

Title	Comfort While Working on Computer
Description	Comfort throughout the day was evaluated via subjective question: "Comfort while working on computer" and is reported as an aggregate of "Agree Strongly and Agree Somewhat".
Time Frame	1-week-follow-up

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Etafilcon A	Ocufilcon D
Arm/Group Description	etafilcon A contact lenses worn in either the first or second period.	ocufilcon D contact lenses worn in either the first or second period.
Measure Participants	51	49
Number [percentage of participants]	47.0 94%	42.9 NaN

Adverse Events

Arm/Group Title	Etafilcon A/ Ocufilcon D		Ocufilcon D / Etafilcon A		Etafilcon A/ Etafilcon A		Oculfilcon D / Ocufilcon D
Arm/Group Description	etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second		ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.		etafilcon A contact lenses worn first and second period.		ocufilcon D contact lenses worn first and second period.
All Cause Mortality
	Etafilcon A/ Ocufilcon D		Ocufilcon D / Etafilcon A		Etafilcon A/ Etafilcon A		Oculfilcon D / Ocufilcon D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Etafilcon A/ Ocufilcon D		Ocufilcon D / Etafilcon A		Etafilcon A/ Etafilcon A		Oculfilcon D / Ocufilcon D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/13 (0%)		0/13 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	Etafilcon A/ Ocufilcon D		Ocufilcon D / Etafilcon A		Etafilcon A/ Etafilcon A		Oculfilcon D / Ocufilcon D
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/13 (0%)		0/13 (0%)		0/12 (0%)

Limitations/Caveats

The integrity of the subject reported data is suspect and not reflective of lens' performance due to a significant protocol deviation. Upon completion of the study it was found that subjects were unmasked and their data should be considered biased.

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.