Evaluation of Comfilcon A and Senofilcon A Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01695369
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Evaluation of Comfilcon A and Senofilcon A Lenses

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Senofilcon A; Comfilcon A; Device: Comfilcon A; Senofilcon A	N/A

Detailed Description

Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Senofilcon A Senofilcon A; Comfilcon A	Device: Senofilcon A; Comfilcon A; Senofilcon A; Comfilcon A; Device: Comfilcon A; Senofilcon A; Comfilcon A; Senofilcon A
Experimental: Comfilcon A Comfilcon A; Senofilcon A	Device: Senofilcon A; Comfilcon A; Senofilcon A; Comfilcon A; Device: Comfilcon A; Senofilcon A; Comfilcon A; Senofilcon A

Outcome Measures

Primary Outcome Measures

1. Subjective Responses for Comfort Rated on a 0-100 Visual Scale. [Baseline Insertion, 10 Minutes, 5 hours and 10 hours]

   Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

• Has had an oculo-visual examination in the last two years

• Is at least 18 years of age and has full legal capacity to volunteer

• Has read and understood the information consent letter

• Is willing and able to follow instructions and maintain the appointment schedule

• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction

• Currently wears soft contact lenses at least 3 days a week, 8 hours a day

• Has clear corneas and no active ocular disease

• Has not worn lenses for at least 12 hours before the examination

• 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 (e.g. entropion, ectropion, chalazia, recurrent styes)

• No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).

• No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)

• No aphakia

• Has prescription to match the available power range.

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

• Greater than 0.75 of refractive astigmatism in either eye

• Has never worn contact lenses before

• Wears contact lenses on an extended wear basis

• Has any systemic disease affecting ocular health

• Is a known sufferer of ocular allergies

• Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants

• Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities

• Is aphakic

• Has undergone corneal refractive surgery.

• Is wearing monovision

• Is participating in any other type of clinical or research study

• Female who is currently pregnant or is breast-feeding

• Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Houston College of Optometry, TERTC	Houston	Texas	United States	77204

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Jan Bergmanson, OD, PhD, University of Houston College of Optometry, TERTC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT01695369
• Other Study ID Numbers: CV-12-54
• First Posted: Sep 28, 2012
• Last Update Posted: Jul 28, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye. The subject is expected to attend the baseline visit not wearing their habitual contact lens products for at least 12 hours.

Arm/Group Title	Overall Study Participants
Arm/Group Description	Senofilcon A and Comfilcon A
Period Title: Overall Study
STARTED	61
COMPLETED	61
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study Participants
Arm/Group Description	Senofilcon A and Comfilcon A
Overall Participants	61
Age, Customized (eyes) [Number]
<=18 years	0
Between 18 and 65 years	61
>=65 years	0
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26 (6)
Sex: Female, Male (Count of Participants)
Female	38 62.3%
Male	23 37.7%
Region of Enrollment (participants) [Number]
United States	61 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
Description	Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
Time Frame	Baseline Insertion, 10 Minutes, 5 hours and 10 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Comfilcon A	Senofilcon A
Arm/Group Description	comfilcon A (CooperVision Biofinity®Sphere)	Senofilcon A (Vistakon Acuvue® Oasys)
Measure Participants	61	61
Baseline Insertion	86 (15)	87 (13)
10 Minutes	89 (14)	91 (12)
5 Hours	83 (19)	84 (18)
10 Hours	79 (23)	81 (21)

Adverse Events

Arm/Group Title	Overall Study Participants		Comfilcon A
Arm/Group Description	Senofilcon A and Comfilcon A		Comfilcon A / CooperVision Biofinity Sphere
All Cause Mortality
	Overall Study Participants		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Overall Study Participants		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/61 (0%)
Other (Not Including Serious) Adverse Events
	Overall Study Participants		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/61 (0%)		0/61 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.