Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02921412
• Collaborator: (none)
• Enrollment: 37
• Locations: 4
• Arms: 2
• Actual Duration (Months): 5.6
• Patients Per Site: 9.3
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

This is a prospective, multi-center, subject-masked, bilateral, daily wear, two-month dispensing study

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: fanfilcon A	N/A

Detailed Description

The aim of this study is to determine if adapted contact lens wearers enfilcon A toric lenses can be confidently refit into fanfilcon A toric lenses and can be successful after one month of daily wear.

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Performance of Fanfilcon A Toric Lenses After at Least One Month Wearing Enfilcon A Toric Lenses
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Feb 1, 2017
• Actual Study Completion Date: Mar 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: enfilcon A (habitual) All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.
Active Comparator: fanfilcon A All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses.	Device: fanfilcon A; contact lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [baseline, 2 weeks, 1 month]

   High contrast distance visual acuity is measured by LogMAR.

2. Centration [baseline, 2 weeks, 1 month]

   Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).

3. Corneal Coverage [baseline, 2 weeks, 1 month]

   Corneal coverage will be assessed (yes/no)

4. Post-blink Movement [baseline, 2 weeks, 1 month]

   Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)

5. Fit Acceptability [baseline, 2 weeks, 1 month]

   Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 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 40 years of age (inclusive)

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

• Is a habitual soft toric lens wearer

• Can be successfully fit with study lenses (≥ grade 2 fit acceptance)

• Has a contact lens spherical prescription between -1.00 to -6.00D with a cylinder between -0.75 and -1.75D (Diopters) (inclusive)

• Has a spectacle cylinder of at least 0.75D in each eye.

• Can achieve best corrected spectacle refraction 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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Contact Lens Service	Miami	Florida	United States	33136
2	Debbie Kim	Closter	New Jersey	United States	07624
3	West Village Eyecare	New York	New York	United States	10014
4	Spokane Eye Clinic	Spokane	Washington	United States	99204

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Informed Consent Form - Sep 14, 2016
• Study Protocol and Statistical Analysis Plan - Sep 13, 2016

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02921412
• Other Study ID Numbers: EX-MKTG-67
• First Posted: Oct 3, 2016
• Last Update Posted: Apr 10, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Pre-assignment Detail	37 participants were initially enrolled (assigned a study ID), with 1 failing the screening. A total of 36 participants wore the control lens (enfilcon A toric) first and then refitted and dispensed the test lenses (fanfilcon A toric) at baseline visit. There were no discontinuations.

Arm/Group Title	All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)
Arm/Group Description	All participants wore enfilcon A toric lens (habitual) and then wore fanfilcon A toric lenses for 1 month.
Period Title: Overall Study
STARTED	36
COMPLETED	36
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Enfilcon A Toric / Fanfilcon A Toric
Arm/Group Description	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
Overall Participants	36
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.4 (6.7)
Sex: Female, Male (Count of Participants)
Female	25 69.4%
Male	11 30.6%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	36 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	High contrast distance visual acuity is measured by LogMAR.
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Arm/Group Title	Enfilcon A Toric (Baseline)	Fanfilcon A Toric (Dispense)	Fanfilcon A Toric (2 Weeks)	Fanfilcon A Toric (1 Month)
Arm/Group Description	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
Measure Participants	36	36	35	35
Mean (Standard Deviation) [logMAR]	-0.05 (0.05)	-0.05 (0.05)	-0.05 (0.05)	-0.04 (0.04)

2. Primary Outcome

Title	Centration
Description	Lens centration is assessed (optimum, decentration acceptable, decentration unacceptable).
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Arm/Group Title	Enfilcon A Toric (Baseline)	Fanfilcon A Toric (Dispense)	Fanfilcon A Toric (2 Weeks)	Fanfilcon A Toric (1 Month)
Arm/Group Description	All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (for 1 month) and then refitted with fanfilcon A toric lenses at baseline visit.
Measure Participants	36	36	35	35
Optimum	34 94.4%	35 NaN	30 NaN	33 NaN
Acceptable	1 2.8%	1 NaN	5 NaN	2 NaN
Unacceptable	1 2.8%	0 NaN	0 NaN	0 NaN

3. Primary Outcome

Title	Corneal Coverage
Description	Corneal coverage will be assessed (yes/no)
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Arm/Group Title	Enfilcon A Toric (Baseline)	Fanfilcon A Toric (Dispense)	Fanfilcon A Toric (2 Weeks)	Fanfilcon A Toric (1 Month)
Arm/Group Description	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
Measure Participants	36	36	35	35
Yes	36 100%	36 NaN	35 NaN	35 NaN
No	0 0%	0 NaN	0 NaN	0 NaN

4. Primary Outcome

Title	Post-blink Movement
Description	Post-blink lens movement assessed using the following evaluations (0-4): 0=Insufficient, unacceptable, 1=Minimal, acceptable, 2=Optimal, 3=Moderate, acceptable, 4=Excessive, unacceptable)
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Arm/Group Title	Enfilcon A Toric (Baseline)	Fanfilcon A Toric (Dispense)	Fanfilcon A Toric (2 Weeks)	Fanfilcon A Toric (1 Month)
Arm/Group Description	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
Measure Participants	36	36	35	35
Mean (Standard Deviation) [units on a scale]	1.83 (0.51)	1.92 (0.50)	1.69 (0.47)	1.86 (0.49)

5. Primary Outcome

Title	Fit Acceptability
Description	Investigator fit acceptability for each lens pair. Scale 0-4: (0=should not be worn, 1=borderline but unacceptable, 2=minimally acceptable, early review, 3=not perfect but OK to dispense, 4=perfect)
Time Frame	baseline, 2 weeks, 1 month

Outcome Measure Data

Analysis Population Description

Analysis was performed prior to one participant completing the 2 week and 1 month visits.

Arm/Group Title	Enfilcon A Toric (Baseline)	Fanfilcon A Toric (Dispense)	Fanfilcon A Toric (2 Weeks)	Fanfilcon A Toric (1 Month)
Arm/Group Description	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.	All participants wear enfilcon A toric lens (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
Measure Participants	36	36	35	35
Mean (Standard Deviation) [units on a scale]	3.3 (0.6)	3.3 (0.5)	3.1 (0.8)	3.1 (0.6)

Adverse Events

Time Frame	Adverse event data collected at all scheduled visits over a 1 month period of time
Arm/Group Title	All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)
Arm/Group Description	All participants wore enfilcon A toric lenses (habitual) and then refitted with fanfilcon A toric lenses at baseline visit.
All Cause Mortality
	All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)
	Affected / at Risk (%)	# Events
Total	0/36 (0%)
Serious Adverse Events
	All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)
	Affected / at Risk (%)	# Events
Total	0/36 (0%)
Other (Not Including Serious) Adverse Events
	All Participants (Enfilcon A Toric / Fanfilcon A Toric Lenses)
	Affected / at Risk (%)	# Events
Total	0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Disclosure restriction on the PI is that the sponsor should be notified of any results communications and has ability to review.