Evaluation of Enfilcon A Soft Contact Lens When Compared to Galyfilcon A Soft Contact Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01706770
• Collaborator: (none)
• Enrollment: 50
• Locations: 3
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 16.7
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

The primary objective of thes study is to confirm that the ocular response to the Test lenses are similar to those of the Control lenses when used in a 1 week planned replacement, daily wear modality over a 1-month period.

Condition or Disease	Intervention/Treatment	Phase
Ametropia	Device: enfilcon A; Device: galyfilcon A	N/A

Detailed Description

The test lens and control lens were randomized in a 2:1 ratio to evaluate the test lens and control contact lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Enfilcon A Soft Contact Lens Compared to Galyfilcon A Soft Contact Lens
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: enfilcon A The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Device: enfilcon A; Other Names: Avaira® Toric
Active Comparator: galyfilcon A The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Device: galyfilcon A; Other Names: Acvuve® Advance®

Outcome Measures

Primary Outcome Measures

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

   The primary safety endpoint are the objective slit lamp findings associated with the enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A 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/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 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 baseline to 1 month visit]

   The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A 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 from Baseline through end of month 1 visit.

Eligibility Criteria

Criteria

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

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 in both eyes 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 2.00 diopters 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 study period.

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

• Has a known sensitivity to ingredients used in the care products 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.

• Any; inflammations such as iritis; or any infection or allergic reaction 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 1, 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	Advanced Eyecare	Pismo Beach	California	United States	93449
2	Eric M. White, OD, Inc.	San Diego	California	United States	48823
3	Vision Care Associates	East Lansing	Michigan	United States	48823

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Scott E Schachter, OD, Unafiliated
• Principal Investigator: Cheryl Vincent-Reimer, OD, Unafiliated
• Principal Investigator: Eric White, OD, Unafiliated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01706770
• Other Study ID Numbers: FC111216
• First Posted: Oct 15, 2012
• Last Update Posted: Oct 5, 2020
• Last Verified: Sep 1, 2020

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

Study Results

Participant Flow

Recruitment Details	52 subjects evaluated. Of these 52 subjects, 2 found ineligible and not randomized resulting in 50 subjects randomized, 33 test, 17 control. Of 50 subjects randomized, 2 discontinued and not included in results data, 31 test, 17 control, 1 lost to follow-up, 1 Sponsor/IRB decision due to pregnancy at one month visit.

Arm/Group Title	Enfilcon A	Galyfilcon A
Arm/Group Description	The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Period Title: Overall Study
STARTED	33	17
COMPLETED	31	17
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Enfilcon A	Galyfilcon A	Total
Arm/Group Description	The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	Total of all reporting groups
Overall Participants	33	17	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	33 100%	17 100%	50 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.8 (11.11)	33.8 (11.50)	34.4 (11.13)
Sex: Female, Male (Count of Participants)
Female	23 69.7%	12 70.6%	35 70%
Male	10 30.3%	5 29.4%	15 30%
Region of Enrollment (participants) [Number]
United States	33 100%	17 100%	50 100%

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 enfilcon A contact lenses compared with those same findings reported as associated with the galyfilcon A 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/Dispensing (baseline and dispensing visit combined), Post-Dispensing (after lenses were dispensed and allowed to settle) and All Follow-Ups (week 1 visit, week 2 visit, month 1 visit combined). The average grade for unique eyes with findings greater than 0 (none) is compared.
Time Frame	Change from baseline/dispensing visits, post-dispensing 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	Enfilcon A	Galyfilcon A
Arm/Group Description	The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Measure Participants	31	17
Measure unique eyes	62	34
Epithelial Edema, Baseline/Dispensing	1.00	NA
Epithelial Edema, Post-Dispensing	NA	NA
Epithelial Edema, All Follow-up	NA	NA
Stromal Edema, Basline/Dispensing	NA	NA
Stromal Edema, Post-Dispensing	NA	NA
Stromal Edema, All Follow-up	NA	NA
Neovascularization, Baseline/Dispensing	1.00	1.00
Neovascularization, Post-Dispensing	NA	1.00
Neovascularization, All Follow-up	1.00	1.00
Corneal Staining, Baseline/Dispensing	1.06	1.08
Corneal Staining, Post-Dispensing	1.00	1.00
Corneal Staining, All Follow-up	1.02	1.04
Limbal Hyperemia, Baseline/Dispensing	1.07	1.00
Limbal Hyperemia, Post-Dispensing	1.00	1.00
Limbal Hyperemia, All Follow-up	1.00	1.00
Bulbar Hyperemia, Baseline/Dispensing	1.00	1.00
Bulbar Hyperemia, Post-Dispensing	1.00	1.00
Bulbar Hyperemia, All Follow-up	1.00	1.00
Palpebral Conjunctiva, Baseline/Dispensing	1.11	1.12
Palpebral Conjunctiva, Post-Dispensing	1.00	1.14
Palpebral Conjunctiva, All Follow-up	1.05	1.16

2. Primary Outcome

Title	Comparison of Objective Findings - Number of Adverse Events in Unique Eyes
Description	The primary safety endpoint are the objective findings of the number of adverse events in unique eyes associated with the enfilcon A contact lenses compared with those same findings as associated with the galyfilcon A 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 from Baseline through end of month 1 visit.
Time Frame	Any occurrence from baseline to 1 month visit

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Enfilcon A	Galyfilcon A
Arm/Group Description	The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.	The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
Measure Participants	31	17
Measure eyes	62	34
Number [number of adverse events]	0	2

Adverse Events

Time Frame	From dispense up to one month on both the study lenses, a total of two months.
Arm/Group Title	Enfilcon A		Galyfilcon A
Arm/Group Description	The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.		The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
All Cause Mortality
	Enfilcon A		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/17 (0%)
Serious Adverse Events
	Enfilcon A		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Enfilcon A		Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		1/17 (5.9%)
Eye disorders
Temporary Discontinuation of Lens Wear	0/33 (0%)	0	1/17 (5.9%)	1

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 (see protocol) requires the prior written permission from the study Sponsor. Study investigators and all office personnelare prohibited from acknowledging participation in the study to individuals and organizations except those listed.