Clinical Evaluation of Stenfilcon A Soft Contact Lens When Compared to Ocufilcon B Soft Contact Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01354223
• Collaborator: (none)
• Enrollment: 90
• Locations: 4
• Arms: 2
• Duration (Months): 6
• Patients Per Site: 22.5
• Patients Per Site Per Month: 3.8

Study Details

Study Description

Brief Summary

This study seeks to evaluate a new daily disposable contact lens compared to an existing daily disposable contact lens.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: stenfilcon A contact lens; Device: ocufilcon B contact lens	N/A

Detailed Description

This study is designed to evaluate the stenfilcon A contact lens to demonstrate substantial equivalence to the Ocufilcon B for market release.

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of the CooperVision Stenfilcon A Soft Contact Lens for Daily Wear When Compared to the CooperVision Ocufilcon B Soft Contact Lens
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: stenfilcon A contact lens Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Device: stenfilcon A contact lens; Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
Active Comparator: ocufilcon B contact lens Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode	Device: ocufilcon B contact lens; Daily disposable contact lens worn in a daily wear, daily disposable mode; Other Names: CooperVision ClearSight™ 1 Day

Outcome Measures

Primary Outcome Measures

1. Objective Assessment: Ocular Response - Biomicroscopy [Change from baseline visit and all follow-ups visits]

   The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.

2. Comparison of Objective Findings - Number of Adverse Events in Unique Eyes [Any occurrence from dispensing to month 3 visit]

   The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).

3. Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better [week 1 visit, week 2 visit, month 1 visit, month 2 visit combined]

   The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.

Secondary Outcome Measures

1. Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort [Baseline, Week 1, Week 2, Month 1, Month 2, Month 3]

   The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens. Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).

2. Evaluation of Average Lens Wearing Time - Average Daily Hours Worn [Baseline, Week 1, Week 2, Month 1, Month 2, Month 3]

   The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Prior to being considered eligible to participate in this study, each subject MUST:

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

• Have:

• Read the Informed Consent

• been given an explanation of the Informed Consent

• indicated understanding of the Informed Consent

• signed the Informed Consent document.

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

• 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.

• Possess wearable and visually functional eyeglasses.

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

• Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes.

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

• 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:

Subjects may not be enrolled in this study if any of the following apply: The subject is/has:

• 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.

• Poor personal hygiene.

• Any active participation in another clinical trial within 30 days prior to this study.

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

• A member, relative or household member of the investigator or of the investigational office staff.

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

• Previous refractive surgery; or current or previous orthokeratology treatment.

• Is aphakic or psuedophakic.

• 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.

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

• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.

• A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.

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

• 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

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

• Giant papillary conjunctivitis (GPC) of > Grade 2

• Anterior uveitis or iritis

• Seborrheic eczema, seborrheic conjunctivitis or blepharitis

To be eligible to be randomized for study product a subject must have ALL of the Inclusion Criteria and have NONE of the exclusion criteria present.

To be eligible for lens dispensing (either Test or Control), the subject's study lens contact lens visual acuity must be equal to or better than 20/30 in each eye.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eric M. White, OD, Inc.	San Diego	California	United States	92123
2	Vision Care Associates	East Lansing	Michigan	United States	48823
3	Western Reserve Vision Care	Beachwood	Ohio	United States	44122
4	Primary Eyecare Group, P.C.	Brentwood	Tennessee	United States	37027

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Stephen Byrnes, OD,
• Principal Investigator: Lee Rigel, OD,
• Principal Investigator: Mary Jo Stiegemeier, OD,
• Principal Investigator: Peter Van Hoven, OD,
• Principal Investigator: Eric White, OD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01354223
• Other Study ID Numbers: FC100239
• First Posted: May 16, 2011
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Coopervision, Inc.: silicone hydrogel contact lens; SHCL; stenfilcon A; ocufilcon B; daily disposable; substantial equivalence; CooperVision ClearSight™ 1 Day SCL
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	Ninety-three subjects evaluated, 3 subjects found to be ineligible and not randomized or dispensed. 90 adapted single-vision contact lens wearers with myopia were randomized and dispensed on a 2 to 1 ratio within each site and across entire study. Subjects used that same assigned product throughout study duration

Arm/Group Title	Stenfilcon A Contact Lens	Ocufilcon B Contact Lens
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Period Title: Overall Study
STARTED	60	30
COMPLETED	57	29
NOT COMPLETED	3	1

Baseline Characteristics

Arm/Group Title	Stenfilcon A Contact Lens	Ocufilcon B Contact Lens	Total
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode	Total of all reporting groups
Overall Participants	60	30	90
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	60 100%	30 100%	90 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.6 (8.884)	29.8 (8.550)	31.7 (8.822)
Sex: Female, Male (Count of Participants)
Female	38 63.3%	21 70%	59 65.6%
Male	22 36.7%	9 30%	31 34.4%
Region of Enrollment (participants) [Number]
United States	60 100%	30 100%	90 100%

Outcome Measures

1. Primary Outcome

Title	Objective Assessment: Ocular Response - Biomicroscopy
Description	The primary safety endpoint are the objective slit lamp findings associated with the stenfilcon A contact lenses compared with those same findings reported as associated with the ocufilcon B contact lenses. The incidence of biomicroscopy findings (0=not present, 4=severe) over the duration of the study with the highest reported grade was chosen for each unique eye. Biomicroscopy measurements were obtained at Baseline (baseline visit) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit, month 2 visit combined).The average grade for unique eyes with findings greater than 0 (none) is compared.
Time Frame	Change from baseline visit and all follow-ups visits

Outcome Measure Data

Analysis Population Description

Unique eyes are defined as each individual eye in the study and are only counted once for each of the visit groupings

Arm/Group Title	Stenfilcon A Contact Lens	Ocufilcon B Contact Lens
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Measure Participants	57	29
Measure unique eyes	114	58
Neovascularization, Baseline	1.00	1.00
Neovascularization, All Follow-up	1.00	1.10
Corneal Staining, Baseline	1.00	1.00
Corneal Staining, All Follow-up	1.09	1.18
Limbal Hyperemia, Baseline	1.00	1.00
Limbal Hyperemia, All Follow-up	1.03	1.05
Bulbar Hyperemia, Baseline	1.00	1.00
Bulbar Hyperemia, All Follow-up	1.05	1.02
Palperbral Conjunctiva, Baseline	1.10	1.00
Palpebral Conjunctiva, All Follow-up	1.38	1.00

2. Primary Outcome

Title	Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
Description	The primary safety endpoint in this evaluation will be a comparison of the objective findings of the number of adverse events in unique eyes associated with the stenfilcon A contact lenses compared with those same findings as associated with ocufilcon B contact lenses. The number of adverse events over the duration of the study was reported for each unique eye (bilateral or unilateral). Observations for adverse events were reported for any occurrence after dispensing (dispensing visit) through end of month 3 visit (month 3 visit).
Time Frame	Any occurrence from dispensing to month 3 visit

Outcome Measure Data

Analysis Population Description

Unique eyes are defined as each individual eye in the study.

Arm/Group Title	Stenfilcon A Contact Lens	Ocufilcon B Contact Lens
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Measure Participants	57	29
Measure unique eyes	114	58
Number [number of adverse events]	7	1

3. Secondary Outcome

Title	Subjective Assessment of Contact Lens Comfort - No Symptoms of Discomfort
Description	The secondary efficacy endpoint is the subjective assessment of contact lens comfort associated with the stenfilcon A contact lens compared with the comfort associated with the ocufilcon B contact lens. Subjective comfort assessment is related by the percent number of unique eyes that were reported to have no symptoms of discomfort (0=no symtoms reported) graded on a severity scale of the reported symptoms (0=no symptoms reported, 4=severe) that was experienced over the past month prior to baseline at the baseline visit (Baseline) and any symptoms of discomfort that was experienced since the previous study visit at each scheduled follow-up visit (Week 1, Week 2, Month 1, Month 2, Month 3).
Time Frame	Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Outcome Measure Data

Analysis Population Description

Unique eyes reporting no symptoms of discomfort/Pain, excessive tearing, photophobia, halos, itching/burning, dryness, variable vision, blurred vision, other symptoms.

Arm/Group Title	Stenfilcon A Contact Lens	Ocufilcon B Contact Lens
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Measure Participants	57	29
Measure unique eyes	114	58
Baseline	73.6	70.4
Week 1	43.9	50.0
Week 2	60.9	55.2
Month 1	55.4	60.3
Month 2	59.6	55.2
Month 3	55.3	58.6

4. Primary Outcome

Title	Comparison of Objective Findings for Contact Lens Visual Acuities - Snellen 20/25 VA or Better
Description	The primary efficacy endpoint are the contact lens Snellen visual acuities (VA) of 20/25 VA or better associated with stenfilcon A compared with those same visual acuities associated with ocufilcon B. Snellen visual acuity (VA) examinations were performed at All Follow-up visits (week 1 visit, week 2 visit, month 1 visit, month 2 visit). The combined results of All Follow-up visits are compared.
Time Frame	week 1 visit, week 2 visit, month 1 visit, month 2 visit combined

Outcome Measure Data

Analysis Population Description

For the completed study subjects, contact lens VA was collected at 562 of the possible 564 examinations (99.6%) for the Test cohort eyes and at 288 of the possible 288 examinations (100%) for the Control cohort eyes.

Arm/Group Title	Stenfilcon A Contact Lens	Ocufilcon B Contact Lens
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Measure Participants	57	29
Measure possible examinations	562	288
Number [percentage of possible examinations]	99.3	100

5. Secondary Outcome

Title	Evaluation of Average Lens Wearing Time - Average Daily Hours Worn
Description	The secondary efficacy endpoint is the objective assessment of the lens average daily wearing times associated with the stenfilcon A compared with the lens average wearing times with the ocufilcon B contact lens. Objective average daily lens wearing time is measured in reported hours worn with the subject's habitual contact lenses recorded at baseline and after dispensing of study lenses recorded at Week 1, Week 2, Month 1, Month 2, Month 3.
Time Frame	Baseline, Week 1, Week 2, Month 1, Month 2, Month 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stenfilcon A Contact Lens	Ocufilcon B Contact Lens
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode	Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
Measure Participants	57	29
Baseline	15.04 (3.846)	13.74 (4.182)
Week 1	13.71 (2.281)	13.18 (2.539)
Week 2	13.69 (2.235)	13.31 (2.523)
Month 1	13.67 (2.520)	12.81 (2.640)
Month 2	13.81 (2.774)	13.41 (2.693)
Month 3	14.00 (2.440)	13.28 (2.576)

Adverse Events

Arm/Group Title	Stenfilcon A Contact Lens		Ocufilcon B Contact Lens
Arm/Group Description	Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode		Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
All Cause Mortality
	Stenfilcon A Contact Lens		Ocufilcon B Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Stenfilcon A Contact Lens		Ocufilcon B Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/60 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Stenfilcon A Contact Lens		Ocufilcon B Contact Lens
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/60 (5%)		0/30 (0%)
Eye disorders
Papillary Conjunctivitis	3/60 (5%)	6	0/30 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Release of this data (through presentation, publication or other written or oral communication) to other than listed personnel (listed in protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnel are prohibited from acknowledging participation in the study to individuals and organizations except those listed.