One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02759471
• Collaborator: (none)
• Enrollment: 54
• Locations: 4
• Arms: 2
• Duration (Months): 4
• Patients Per Site: 13.5
• Patients Per Site Per Month: 3.4

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: comfilcon A sphere lens (control); Device: comfilcon A asphere lens (test)	N/A

Detailed Description

This is a prospective, multi-center, subject-masked, bilateral wear, one month dispensing study comparing the clinical performance of the subjects' habitual comfilcon A sphere lens (control) following a refit with comfilcon A asphere lens (test). After the dispensing visit, subjects will return for follow-up evaluations after 2 weeks, and 1 month.

Both comfilcon A sphere lens (control) and comfilcon A asphere lens (test) are Coopervison lenses.

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: One Month Dispensing Study Comparing the Clinical Performance of the Comfilcon A Sphere Lenses Compared to Comfilcon A Asphere Lenses.
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: comfilcon A asphere (test) Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).	Device: comfilcon A asphere lens (test); contact lens
Active Comparator: comfilcon A sphere (control) Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).	Device: comfilcon A sphere lens (control); contact lens

Outcome Measures

Primary Outcome Measures

1. Lens Fit - Centration [baseline, 2 weeks, 1 month]

   Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).

2. Lens Fit - Corneal Coverage [baseline, 2 weeks, 1 month]

   Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).

3. Lens Fit - Post-blink Movement [baseline, 2 weeks, 1 month]

   Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).

4. Lens Preference/Acceptability [baseline, 2 weeks, 1 month]

   Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 34 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

• Is between 18 and 34 years of age (inclusive)

• Has had a self-reported eye exam in the last two years

• Is an adapted comfilcon A sphere contact lens wearer

• Uses digital devices, (e.g. computer, tablet, smart phone, iPad), for more than 4 hours a day, 5 days a week.

• Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)

• Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.

• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.

• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.

• Has clear corneas and no active ocular disease

• Has read, understood and signed the information consent letter.

• Has a contact lens refraction that fits within the available parameters of the study lenses.

• Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).

• Is willing to comply with the visit schedule

Exclusion Criteria

A person will be excluded from the study if he/she:

• Has a history of not achieving comfortable CL (Contact Lens) wear (5 days per week; > 8 hours/day)

• Presents with clinically significant anterior segment abnormalities

• Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Presents with slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• Significant pterygium, pinguecula, or corneal scars within the visual axis

• Neovascularization > 0.75 mm in from of the limbus

• Giant papillary conjunctivitis (GCP) worse than grade 1

• Anterior uveitis or iritis (or history in past year)

• Seborrheic eczema of eyelid region, Seborrheic conjunctivitis

• History of corneal ulcers or fungal infections

• Poor personal hygiene

• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)

• Has aphakia, keratoconus or a highly irregular cornea.

• Has presbyopia or has dependence on spectacles for near work over the contact lenses.

• Has undergone corneal refractive surgery.

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

• Is habitually using rewetting/ lubricating eye drops (more than once per day)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Golden Optometric Group	Whittier	California	United States	90606
2	Complete Eye Care of Medina	Medina	Minnesota	United States	55340
3	Sacco Eye Group	Vestal	New York	United States	13850
4	Drs. Quinn, Foster, & Associates	Athens	Ohio	United States	45701

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Andrew Sacco, OD, Sacco Eye Group
• Principal Investigator: Gina Wesley, OD, Complete Eye Care of Medina
• Principal Investigator: Thomas Quinn, OD, MS, FAAO, Drs. Quinn, Foster, & Associates
• Principal Investigator: David Ardaya, OD, Golden Optometric Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02759471
• Other Study ID Numbers: EX-MKTG-63
• First Posted: May 3, 2016
• Last Update Posted: Jul 29, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)
Arm/Group Description	Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens
Period Title: Overall Study
STARTED	54
COMPLETED	52
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)
Arm/Group Description	Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens
Overall Participants	54
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	26
Sex: Female, Male (Count of Participants)
Female	35 64.8%
Male	19 35.2%

Outcome Measures

1. Primary Outcome

Title	Lens Fit - Centration
Description	Lens fit evaluation of centration for comfilcon A sphere and comfilcon A asphere lens. (Scale: optimum, decentration acceptable and decentration unacceptable).
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Arm/Group Title	Comfilcon A Sphere (Control)	Comfilcon A Asphere (Test)
Arm/Group Description	habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere	habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Measure Participants	52	52
Baseline, Optimum	48 88.9%	46 NaN
Baseline, Acceptable	4 7.4%	6 NaN
Baseline, Unacceptable	0 0%	0 NaN
At 2 weeks, optimum	NA NaN	45 NaN
At 2 weeks, acceptable	NA NaN	6 NaN
At 2 weeks, unacceptable	NA NaN	0 NaN
At 1 month, optimum	NA NaN	46 NaN
At 1 month, acceptable	NA NaN	5 NaN
At 1 month, unacceptable	NA NaN	0 NaN

2. Primary Outcome

Title	Lens Fit - Corneal Coverage
Description	Lens fit evaluation of corneal coverage for comfilcon A sphere and comfilcon A asphere lens. ('yes' - full coverage, or 'no' - incomplete corneal coverage).
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Arm/Group Title	Comfilcon A Sphere (Control)	Comfilcon A Asphere (Test)
Arm/Group Description	habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere	habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Measure Participants	52	52
Baseline, yes	52 96.3%	52 NaN
2 weeks, yes	51 94.4%	51 NaN
1 month, yes	51 94.4%	51 NaN

3. Primary Outcome

Title	Lens Fit - Post-blink Movement
Description	Lens fit evaluation of post-blink movement for comfilcon A sphere and comfilcon A asphere lens. (Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

One participants data for both the 2 week and 1 month visit was not included due to participant protocol deviation.

Arm/Group Title	Comfilcon A Sphere (Control)	Comfilcon A Asphere (Test)
Arm/Group Description	habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere	habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Measure Participants	52	52
Baseline	1.9 (0.6)	1.9 (0.3)
After 2 weeks	NA (NA)	1.9 (0.4)
After 1 month	NA (NA)	1.9 (0.5)

4. Primary Outcome

Title	Lens Preference/Acceptability
Description	Investigators preference/acceptability for comfilcon A sphere and comfilcon A asphere lenses. (Choices: strongly prefer study lenses, slightly prefer study lenses, slightly prefer habitual lenses, strongly prefer habitual lenses).
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Investigator Rating of Fit Preference
Arm/Group Description	habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
Measure Participants	52
Strongly prefer comfilcon A asphere	5 9.3%
Slightly prefer comfilcon A asphere	39 72.2%
Strongly prefer comfilcon A sphere	8 14.8%
Slightly prefer comfilcon A sphere	0 0%

Adverse Events

Time Frame	4 weeks
Arm/Group Title	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)
Arm/Group Description	Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test). comfilcon A sphere lens (control): contact lens comfilcon A asphere lens (test): contact lens
All Cause Mortality
	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)
	Affected / at Risk (%)	# Events
Total	0/52 (0%)
Other (Not Including Serious) Adverse Events
	Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)
	Affected / at Risk (%)	# Events
Total	0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is an agreement between the Principal Investigator and the Sponsor that restricts the PI's rights to discuss or publish trial results after the trial is completed.