A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03306641
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.1
• Patients Per Site Per Month: 40.3

Study Details

Study Description

Brief Summary

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Test Contact Lens; Device: Nelfilcon A	N/A

Detailed Description

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.This will be a double-masked, bilateral, 1-week crossover, dispensing study, comparing the test daily wear lens against nelfilcon A control lens, such that each lens type will be worn for 1 week each. Each subject will be randomized to wear either the test lenses or the control lenses as a matched pair.
• Masking: Double (Participant, Investigator)
• Masking Description: The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.
• Primary Purpose: Treatment
• Official Title: A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses
• Actual Study Start Date: Jul 28, 2017
• Actual Primary Completion Date: Aug 31, 2017
• Actual Study Completion Date: Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Test Contact Lens Per randomized schedule, subject will wear a pair of the test lens or control lens for one week and then cross-over with the control pair for 1 week.	Device: Test Contact Lens; Daily disposable contact lens; Device: Nelfilcon A; Focus Dailies All Day Comfort contact lens (nelfilcon A)
Active Comparator: nelfilcon A lens (control) Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week.	Device: Test Contact Lens; Daily disposable contact lens; Device: Nelfilcon A; Focus Dailies All Day Comfort contact lens (nelfilcon A)

Outcome Measures

Primary Outcome Measures

1. Lens Fit Acceptance [Baseline]

   Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

2. Lens Fit Acceptance [1-Week]

   Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

• Is no greater than 55 years of age.

• Has read and understood the information consent letter.

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

• Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.

• Has spectacle cylinder ≤1.00D in both eyes.

• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.

• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.

• Wears CLs in both eyes (monvision acceptable, but not monofit)

• Has clear corneas and no active ocular disease.

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

• Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion Criteria:

• Has never worn contact lenses before.

• Has any systemic disease affecting ocular health.

• Is using any systemic or topical medications that will affect ocular health.

• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.

• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.

• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.

• Is aphakic.

• Has strabismus/amblyopia.

• Has undergone corneal refractive surgery.

• Is pregnant, lactating or planning a pregnancy.

• Is participating in any concurrent clinical or research study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University	Bloomington	Indiana	United States	47405

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 14, 2017

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03306641
• Other Study ID Numbers: CV-17-29
• First Posted: Oct 11, 2017
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• 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: Myopia

Study Results

Participant Flow

Arm/Group Title	Test Contact Lens Then Nelfilcon A Lens (Control)	Nelfilcon A Lens (Control) Then Test Contact Lens
Arm/Group Description	Per randomized schedule, subject will wear a pair of the test lens for one week and then cross-over with the control pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)	Per randomized schedule, subject will wear a pair of the control lens for one week and then cross-over with the test pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Period Title: First Intervention
STARTED	23	22
COMPLETED	23	22
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	23	22
COMPLETED	23	22
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Per randomized schedule, subject will wear either a pair of the test lens or control lens for one week and then cross-over to the other pair for 1 week. Test Contact Lens: Daily disposable contact lens Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Overall Participants	45
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	45 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26 (8)
Sex: Female, Male (Count of Participants)
Female	32 71.1%
Male	13 28.9%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	45 100%

Outcome Measures

1. Primary Outcome

Title	Lens Fit Acceptance
Description	Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study. Test Contact Lens: Daily disposable contact lens	Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study. Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	45	45
Mean (Standard Deviation) [units on a scale]	2.6 (0.6)	3.1 (0.3)

2. Primary Outcome

Title	Lens Fit Acceptance
Description	Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
Time Frame	1-Week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Contact Lens	Nelfilcon A Lens (Control)
Arm/Group Description	Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study. Test Contact Lens: Daily disposable contact lens	Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study. Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
Measure Participants	45	45
Mean (Standard Deviation) [units on a scale]	2.6 (0.6)	3.0 (0.4)

Adverse Events

Time Frame	From dispense up to 1-week on each pair of lenses, a total of two weeks.
Arm/Group Title	Test Contact Lens		Nelfilcon A Lens (Control)
Arm/Group Description	Per randomized schedule, subject will wear a pair of the test lens for one week in this cross-over study. Test Contact Lens: Daily disposable contact lens		Per randomized schedule, subject will wear a pair of the control lens for one week in this cross-over study. Nelfilcon A: Focus Dailies All Day Comfort contact lens (nelfilcon A)
All Cause Mortality
	Test Contact Lens		Nelfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Serious Adverse Events
	Test Contact Lens		Nelfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	Test Contact Lens		Nelfilcon A Lens (Control)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/45 (0%)		0/45 (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.