Assessment of Daily Disposable Silicone Hydrogel Lens Wear

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01093625
• Collaborator: Ohio State University (Other)
• Enrollment: 157
• Location: 1
• Arms: 2
• Duration (Months): 14.9
• Patients Per Site Per Month: 10.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effect of an investigational silicone hydrogel soft contact lens on new contact lens wearers (neophytes) compared to a control of spectacle wearers.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Narafilcon B Contact Lens; Device: Spectacles	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 157 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Narafilcon B Contact Lens Investigational Silicone Hydrogel Contact Lens	Device: Narafilcon B Contact Lens; Other Names: Investigational Silicone Hydrogel
Active Comparator: Spectacles	Device: Spectacles; spectacle wearers

Outcome Measures

Primary Outcome Measures

1. Papillary Conjunctivitis [1 Year]

   Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

2. Conjunctival Hyperemia [1 Year]

   Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

3. Limbal Hyperemia [1 Year]

   Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

4. Corneal Staining [1 Year]

   Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.

5. Conjunctival Staining [1 Year]

   Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

6. Corneal Neovascularization [1 Year]

   New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.

7. Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire [1 Year]

   The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.

Secondary Outcome Measures

1. Comfortable Wearing Time [1 Year]

   Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 39 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Able to read, comprehend and sign an informed consent (or parental consent/subject assent, as appropriate).

• Willing to comply with the study visit schedule.

• Ages 15 to 39.

• Has access to a cellular telephone with text messaging capabilities.

• Has a current pair of spectacles.

• 'Neophyte' - In this work, 'neophyte' will be taken to mean any subject who has never been dispensed contact lenses. A subject who has taken part in a non-dispensing clinical study or has been fitted with contact lenses in practice but never went on to actually wear the lenses, will also be classified as a 'neophyte'.

• Spherical contact lens (CL) prescription between -0.75D and -6.00D and spectacle cylinder equal to or less than 0.75 DC.

• Monocular best-corrected distance visual acuity (VA) ≥ 20/30 Snellen in each eye.

• Subject agrees to "intent" of wearing the CLs at minimum 6 hours/day for at least 4 days per week.

• They agree not to participate in other clinical research during the duration of this study.

Exclusion Criteria:

• Active ocular allergy, infection, injury, inflammation, or abnormality (e.g., keratoconus) that might interfere with soft contact lens wear.

• Prior corneal refractive surgery or corneal irregularity (e.g., keratoconus).

• Systemic disease, which might interfere with contact lens wear.

• Medication usage that may be associated with eye dryness.

• Use of any topical medication such as eye drops or ointment.

• Pregnant or lactating (by self-report).

• Aphakia.

• Grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.

• Have participated in any other clinical trial or research in the two weeks prior to starting this study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.
• Ohio State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT01093625
• Other Study ID Numbers: CR-0916
• First Posted: Mar 26, 2010
• Last Update Posted: Jun 19, 2018
• Last Verified: May 1, 2015

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	There were 157 subjects consented to participate in this study. Fifty-nine (59) subjects were determined to be ineligible. This allotted forty-nine (49) subjects randomly to each study arm for a total of 98 subjects enrolled.
Pre-assignment Detail	Of the 59 identified as ineligible prior to group assignment, the majority were due to having a preexisting astigmatism.

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Period Title: Baseline and Dispensed
STARTED	49	49
COMPLETED	47	49
NOT COMPLETED	2	0
Period Title: Baseline and Dispensed
STARTED	47	49
COMPLETED	46	49
NOT COMPLETED	1	0
Period Title: Baseline and Dispensed
STARTED	46	49
COMPLETED	44	49
NOT COMPLETED	2	0
Period Title: Baseline and Dispensed
STARTED	44	49
COMPLETED	42	49
NOT COMPLETED	2	0
Period Title: Baseline and Dispensed
STARTED	42	49
COMPLETED	34	40
NOT COMPLETED	8	9
Period Title: Baseline and Dispensed
STARTED	34	40
COMPLETED	29	37
NOT COMPLETED	5	3

Baseline Characteristics

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles	Total
Arm/Group Description	Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group.	Subjects are randomized to this Control Group.	Total of all reporting groups
Overall Participants	49	49	98
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	49 100%	49 100%	98 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	22.57 (6.67)	23.31 (6.08)	22.94 (6.36)
Sex: Female, Male (Count of Participants)
Female	28 57.1%	21 42.9%	49 50%
Male	21 42.9%	28 57.1%	49 50%
Region of Enrollment (participants) [Number]
United States	49 100%	49 100%	98 100%

Outcome Measures

1. Primary Outcome

Title	Papillary Conjunctivitis
Description	Swelling of the papillary (Papillary conjunctivitis) area of the eye was assessed using a slit-lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Measure Participants	29	37
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.98	0.47

2. Primary Outcome

Title	Conjunctival Hyperemia
Description	Comparison of the amount of redness in the conjunctival area of the eye, between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Measure Participants	29	37
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.26	0.28

3. Primary Outcome

Title	Limbal Hyperemia
Description	Swelling of the vessels in the limbal area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Measure Participants	29	37
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.56	0.30

4. Primary Outcome

Title	Corneal Staining
Description	Abrasions in the cornea area of the eye using a slit lamp. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Measure Participants	29	37
Least Squares Mean (95% Confidence Interval) [Efron Scale (0.1 Unit increments)]	0.26	0.12

5. Primary Outcome

Title	Conjunctival Staining
Description	Mild abrasions of the conjunctival area of the eye. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Measure Participants	29	37
Least Squares Mean (95% Confidence Interval) [units on a scale]	1.41	0.39

6. Primary Outcome

Title	Corneal Neovascularization
Description	New vascularization of the Cornea. Comparison between the two study arms will be assessed using data generated from a slit-lamp examination, using an Efron scale with 0.1 unit increments. The Efron scale has a range of 0 (normal) to 4 (Severe) and is subjectively assessed for 0.1 increments by the clinician, with the higher the magnitude of the number the worse the score.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens	Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.	Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
Measure Participants	29	37
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.30	0.09

7. Primary Outcome

Title	Differences in Subjective Comfort From the Contact Lens User Experience (CLUE) Questionnaire
Description	The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response, with a range of 0-120. The differences between: (final visit and first visit) and then (final visit and 6 months) are reported.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
Measure Participants	29
Comparison of First Visit - Last Visit	-4.97
Comparison of 6-Month Visit - Last Visit	0.62

8. Secondary Outcome

Title	Comfortable Wearing Time
Description	Average numbers of overall average daily contact lens wear hours and average daily comfortable wear hours as reported at each follow-up visit.
Time Frame	1 Year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
Measure Participants	29
Least Squares Mean (95% Confidence Interval) [Hours]	10.25

Adverse Events

Arm/Group Title	Investigational Silicone Hydrogel Contact Lens		Spectacles
Arm/Group Description	Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.		Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
All Cause Mortality
	Investigational Silicone Hydrogel Contact Lens		Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Investigational Silicone Hydrogel Contact Lens		Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Investigational Silicone Hydrogel Contact Lens		Spectacles
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/49 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Publication required agreement and written authorization from the Sponsor