Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01386008
• Collaborator: (none)
• Enrollment: 28
• Locations: 2
• Arm: 1
• Duration (Months): 1
• Patients Per Site: 14
• Patients Per Site Per Month: 13.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: senfilcon A contact lens; Device: investigational enfilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: enfilcon A + senofilcon A Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other	Device: senfilcon A contact lens; senofilcon A spherical contact lens worn in a daily wear modality; Device: investigational enfilcon A; investigational enfilcon A, worn daily wear modality

Outcome Measures

Primary Outcome Measures

1. Subjective Comfort Preference - Participants Preference Response [V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)]

   Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.

2. Ocular Health [Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)]

   Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.

Secondary Outcome Measures

1. Investigator Surface Preference [V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)]

   Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)

2. Investigator Fit Preference [V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)]

   Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Be at least 18 years of age as of the date of evaluation for the study.

2. Not using any ocular medications

3. Have a self-reported full eye examination within 2 years.

4. Have:

• read the Informed Consent

• be given an explanation of the Informed Consent

• indicate understanding of the Informed Consent

• signed the Informed Consent document.

1. Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.

2. Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.

3. Possess wearable and visually functional eyeglasses.

4. Be in good general health, based on his/her knowledge.

5. Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.

6. Be willing to wear contact lenses in both eyes.

7. Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) in each eye.

8. Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.

Exclusion Criteria:

1. Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.

2. Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing trial within 30 days prior to this study.

3. Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next month.

4. Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.

5. Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.

6. Is aphakic or pseudophakic.

7. Unable to achieve a satisfactory fit with the lens designs used in the study

8. Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.

9. The need for topical ocular medications or any medication which might contradict contact lens wear or which would require the lenses to be removed during the day.

10. The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.

11. A history of herpetic keratitis.

12. A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.

13. A history of papillary conjunctivitis that has interfered with contact lens wear.

14. Slit lamp findings that would contraindicate contact lens wear, including but not limited to:

• Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > grade 2

• Pterygium

• Corneal scars within the visual axis

• Corneal edema or corneal staining ≥ grade 2

• Neovascularization or ghost vessels > 1.0 mm in from the limbus

• Giant papillary conjunctivitis (GPC) of > grade 2.

• Seborrheic eczema, seborrheic conjunctivitis or blepharitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center, University of California, Berkeley	Berkeley	California	United States	94704
2	University of Manchester	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01386008
• Other Study ID Numbers: CV-10-50
• First Posted: Jun 30, 2011
• Last Update Posted: Sep 4, 2019
• Last Verified: Aug 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Recruitment Details	28 recruited, 4 disqualified due to significant anterior ocular health findings, 4 passed screening and scheduled for lense fit/dispense when study discontinued.

Arm/Group Title	Overall Study Group
Arm/Group Description	Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear.
Period Title: Overall Study
STARTED	20
COMPLETED	0
NOT COMPLETED	20

Baseline Characteristics

Arm/Group Title	Overall Study Group
Arm/Group Description	Participants wear one enfilcon A (test) contact lens in one eye and one senofilcon A (comparator) contact lens in the other. Both lenses are worn daily wear.
Overall Participants	20
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 100%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	23 (3)
Sex: Female, Male (Count of Participants)
Female	16 80%
Male	4 20%

Outcome Measures

1. Secondary Outcome

Title	Investigator Surface Preference
Description	Investigator Surface Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)
Time Frame	V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Outcome Measure Data

Analysis Population Description

Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.

Arm/Group Title	Enfilcon A + Senofilcon A
Arm/Group Description	Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Measure Participants	20
Preferred Test Lens V1	6 30%
No Preference V1	5 25%
Preferred Control Lens V1	9 45%
Preferred Test Lens V2	0 0%
No Preference V2	1 5%
Preferred Control Lens V2	0 0%

2. Primary Outcome

Title	Subjective Comfort Preference - Participants Preference Response
Description	Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.
Time Frame	V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Outcome Measure Data

Analysis Population Description

Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.

Arm/Group Title	Enfilcon A + Senofilcon A
Arm/Group Description	Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Measure Participants	20
Preferred Test lens Visit 1	7 35%
No Preference Visit 1	8 40%
Preferred Control Lens Visit 1	5 25%
Preferred Test lens Visit 2	0 0%
No Preference Visit 2	1 5%
Preferred Control lens Visit 2	0 0%

3. Primary Outcome

Title	Ocular Health
Description	Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.
Time Frame	Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Outcome Measure Data

Analysis Population Description

Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. Change from baseline V1 over 30 days V4 cannot be analyzed.

Arm/Group Title	Enfilcon A + Senofilcon A
Arm/Group Description	Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Measure Participants	0

4. Secondary Outcome

Title	Investigator Fit Preference
Description	Investigator Fit Preference rated on a linear scale (Lens assessment biomicroscopy: 1=strong R, 2=slight R, 3=No Pref, 4=slight L, 5=strong L)
Time Frame	V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)

Outcome Measure Data

Analysis Population Description

Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up. V3 and V4 cannot be analyzed.

Arm/Group Title	Enfilcon A + Senofilcon A
Arm/Group Description	Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
Measure Participants	20
Preferred Test Lens V1	7 35%
No Preference V1	10 50%
Preferred Control Lens V1	3 15%
Preferred Test Lens V2	1 5%
No Preference V2	0 0%
Preferred Control Lens V2	0 0%

Adverse Events

Arm/Group Title	Overall Study Group
Arm/Group Description	investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
All Cause Mortality
	Overall Study Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Overall Study Group
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Overall Study Group
	Affected / at Risk (%)	# Events
Total	3/20 (15%)
Eye disorders
blurred vision	3/20 (15%)	3

Limitations/Caveats

Incomplete data sets / Data not analyzed / Not all subjects completed the study measures at each outcome measurement time frame before the study was terminated. 20 participants completed V1 and only 1 participant completed the V2 follow-up.

More Information

Certain Agreements

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

The principal investigators are not permitted to publish or make public any of the results without prior written approval from the Sponsor.