Performance of Two Toric Silicone Hydrogel Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03578926
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.7
• Patients Per Site Per Month: 12.2

Study Details

Study Description

Brief Summary

Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: fanfilcon A toric lens; Device: senofilcon A toric lens	N/A

Detailed Description

The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.
• Masking: Double (Participant, Investigator)
• Masking Description: Double masked (participant and investigator)
• Primary Purpose: Treatment
• Official Title: Performance of Toric Silicone Hydrogel Contact Lenses Following Two Weeks of Daily Wear
• Actual Study Start Date: Jun 18, 2018
• Actual Primary Completion Date: Oct 8, 2018
• Actual Study Completion Date: Oct 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fanfilcon A toric lens Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks.	Device: fanfilcon A toric lens; contact lens; Other Names: Avaira Vitality toric lens
Active Comparator: senofilcon A toric lens Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks.	Device: senofilcon A toric lens; contact lens; Other Names: Acuvue Oasys for Astigmatism

Outcome Measures

Primary Outcome Measures

1. Lens Centration [Baseline]

   Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

2. Lens Centration [2 weeks]

   Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)

3. Corneal Coverage [Baseline]

   Lens covering the cornea (Yes, No)

4. Corneal Coverage [2 weeks]

   Lens covering the cornea (Yes, No)

5. Post Blink Movement [Baseline]

   Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

6. Post Blink Movement [2 weeks]

   Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)

Secondary Outcome Measures

1. Wearing Time [2 weeks]

   Average daily wearing time (hours/day)

2. Comfortable Wearing Time [2 weeks]

   Comfortable daily wearing time (hours/day)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Is between 18 and 40 years of age (inclusive)

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

• Is an adapted soft contact lens wearer

• Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive)

• Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes.

• 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.

• Patient contact lens refraction should fit 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:

• Has a CL prescription outside the range of the available parameters of the study lenses.

• Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye.

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

• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.

• Presence of clinically significant (grade 2-4) anterior segment abnormalities

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

• Slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings

• 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 (past or present)

• Seborrheic eczema, 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Optometry Clinic, National Autonomous University	Mexico City		Mexico

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Ruben Velázquez Guerrero, MSc., FIACLE, School of Optometry, National Autonomous University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 23, 2018

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03578926
• Other Study ID Numbers: EX-MKTG-93
• First Posted: Jul 6, 2018
• Last Update Posted: Dec 10, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Recruitment Details	45 habitual lens wearers were enrolled. 1 participant was ineligible for the study due to an unacceptable lens fit. 44 participants were dispensed and completed all study visits.

Arm/Group Title	Fanfilcon A Toric	Senofilcon A Toric
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. Contact Lens: fanfilcon A toric	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. Contact Lens: senofilcon A toric
Period Title: First Intervention
STARTED	21	23
COMPLETED	21	23
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	23	21
COMPLETED	23	21
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	All subjects are randomized to 2-week cross-over study to compare fanfilcon A and senofilcon A.
Overall Participants	44
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	44 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	25 (7.2)
Sex: Female, Male (Count of Participants)
Female	30 68.2%
Male	14 31.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Mexico	44 100%

Outcome Measures

1. Primary Outcome

Title	Lens Centration
Description	Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A	Senofilcon A
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Measure Participants	44	44
Count of Participants [Participants]	44 100%	44 NaN

2. Primary Outcome

Title	Lens Centration
Description	Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A	Senofilcon A
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Measure Participants	44	44
Optimal Centration	44 100%	44 NaN
Decentration Acceptable	0 0%	0 NaN
Decentration unacceptable	0 0%	0 NaN

3. Primary Outcome

Title	Corneal Coverage
Description	Lens covering the cornea (Yes, No)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A	Senofilcon A
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Measure Participants	44	44
Yes	44 100%	44 NaN
No	0 0%	0 NaN

4. Primary Outcome

Title	Corneal Coverage
Description	Lens covering the cornea (Yes, No)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A	Senofilcon A
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Measure Participants	44	44
Yes	44 100%	44 NaN
No	0 0%	0 NaN

5. Primary Outcome

Title	Post Blink Movement
Description	Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A	Senofilcon A
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	1.91 (0.3)	1.98 (0.3)

6. Primary Outcome

Title	Post Blink Movement
Description	Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A	Senofilcon A
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. contact lens: fanfilcon A	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. contact lens: senofilcon A
Measure Participants	44	44
Mean (Standard Deviation) [units on a scale]	2.00 (0.0)	2.02 (0.3)

7. Secondary Outcome

Title	Wearing Time
Description	Average daily wearing time (hours/day)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A - 2 Weeks	Senofilcon A - 2 Weeks
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. fanfilcon A: contact lens	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. senofilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [hours/day]	12.2 (2.9)	11.6 (3.1)

8. Secondary Outcome

Title	Comfortable Wearing Time
Description	Comfortable daily wearing time (hours/day)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Fanfilcon A - 2 Weeks	Senofilcon A - 2 Weeks
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. fanfilcon A: contact lens	Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. senofilcon A: contact lens
Measure Participants	44	44
Mean (Standard Deviation) [hours/day]	10.0 (3.2)	9.0 (3.0)

Adverse Events

Time Frame	2 weeks during each crossover period
Arm/Group Title	Fanfilcon A		Senofilcon A
Arm/Group Description	Randomized participants will wear fanfilcon A toric contact lenses bilaterally for two weeks then switch to senofilcon A toric contact lenses for another two weeks. fanfilcon A toric lens: contact lens		Randomized participants will wear senofilcon A toric contact lenses bilaterally for two weeks then switch to fanfilcon A toric contact lenses for another two weeks. senofilcon A toric lens: contact lens
All Cause Mortality
	Fanfilcon A		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Serious Adverse Events
	Fanfilcon A		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)
Other (Not Including Serious) Adverse Events
	Fanfilcon A		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/44 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.