A Contralateral Dispensing Clinical Trial of Study Test Silicone Hydrogel Lens Against Enfilcon A Silicone Hydrogel Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02537717
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

This will be a 1-month dispensing, double-masked, randomized, contralateral study comparing the test lens against the control lens. The assignment of lenses to eyes (i.e. which lens type is to be worn in which eye throughout the study) will be selected according to a randomization table.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Sapphire Lens; Device: enfilcon A	N/A

Detailed Description

Both test and control lenses will be used in a daily wear modality for 1 month. It is anticipated that this study will involve the following visits: Baseline (screening and dispense visit combined), 2-week visit and 4-week visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Contralateral Dispensing Clinical Trial of Study Test Silicone Hydrogel Lens Against Enfilcon A Silicone Hydrogel Lens
• Actual Study Start Date: Oct 1, 2015
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Apr 29, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sapphire lens Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.	Device: Sapphire Lens; Each subject randomized to wear either the test or control in either the left of right eye.
Active Comparator: enfilcon A Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month.	Device: enfilcon A; Each subject randomized to wear either the test or control in either the left of right eye.

Outcome Measures

Primary Outcome Measures

1. Subjective Ratings of Comfort [Baseline (After 10 minutes of lens dispense)]

   Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever

2. Subjective Ratings of Comfort [2 weeks]

   Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever

3. Subjective Ratings of Comfort [4 weeks]

   Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever

4. Subjective Comfort Preference [Baseline (after 10 minutes of lens dispense)]

   Subjective comfort preference Sapphire lens, Enfilcon A, no preference

5. Subjective Comfort Preference [2 weeks]

   Subjective comfort preference Sapphire lens, Enfilcon A, no preference

6. Subjective Comfort Preference [4 weeks]

   Subjective comfort preference Sapphire lens, Enfilcon A, no preference

7. Lens Wettability [Baseline (After 10 minutes of lens dispense)]

   Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

8. Lens Wettability [2 weeks]

   Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

9. Lens Wettability [4 weeks]

   Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 17 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Is at least 17 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 correction or the assigned study lenses

• Is an adapted soft contact lens wearer (For the purpose of this study: Current lens wear at least 3 days per week, 8 hours each day.)

Exclusion Criteria:

• Is participating in any concurrent clinical or research study

• Has any known active* ocular disease and/or infection;

• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable

• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable^

• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study

• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit). Rationale is that systemic changes over time due to pregnancy/lactating may adversely affect contact lens wear e.g. ocular dryness may increase.

• Is aphakic

• Has undergone corneal refractive surgery.

For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).

^ For the purposes of this study, participants will be excluded, if currently 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Contact Lens Research, University of Waterloo	Waterloo	Ontario	Canada	N2L 3G1

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Lyndon Jones, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02537717
• Other Study ID Numbers: CV-15-55
• First Posted: Sep 2, 2015
• Last Update Posted: Nov 19, 2020
• Last Verified: Oct 1, 2020

• 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	Overall Study
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens. Enfilcon A: contact lens
Period Title: Overall Study
STARTED	17
COMPLETED	17
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens. Enfilcon A: contact lens
Overall Participants	17
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	17 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28 (10)
Sex: Female, Male (Count of Participants)
Female	13 76.5%
Male	4 23.5%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Canada	17 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Ratings of Comfort
Description	Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lens	Enfilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Measure Participants	17	17
Measure eyes	17	17
Mean (Standard Deviation) [units on a scale]	92 (9)	91 (9)

2. Primary Outcome

Title	Subjective Ratings of Comfort
Description	Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lens	Enfilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Measure Participants	17	17
Measure eyes	17	17
Mean (Standard Deviation) [units on a scale]	80 (18)	82 (8)

3. Primary Outcome

Title	Subjective Ratings of Comfort
Description	Subjective ratings of Comfort on a scale (0-100) assessed : 0= Cannot be worn, causes pain, 20=Frequently irritating, 40= Occasionally irritating, 60= Occasionally noticable but not irritating, 80= rarely noticeable, 100= cannot be felt ever
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lens	Enfilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Measure Participants	17	17
Measure eyes	17	17
Mean (Standard Deviation) [units on a scale]	81 (16)	80 (14)

4. Primary Outcome

Title	Subjective Comfort Preference
Description	Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time Frame	Baseline (after 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Study
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens. Enfilcon A: contact lens
Measure Participants	17
Measure Eyes	34
Sapphire lens	47
enfilcon A	12
No preference	41

5. Primary Outcome

Title	Subjective Comfort Preference
Description	Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Study
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens. Enfilcon A: contact lens
Measure Participants	17
Measure Eyes	34
Sapphire lens	53
enfilcon A	18
No preference	29

6. Primary Outcome

Title	Subjective Comfort Preference
Description	Subjective comfort preference Sapphire lens, Enfilcon A, no preference
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Study
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens. Enfilcon A: contact lens
Measure Participants	17
Measure Eyes	34
Sapphire lens	47
enfilcon A	18
No preference	35

7. Primary Outcome

Title	Lens Wettability
Description	Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time Frame	Baseline (After 10 minutes of lens dispense)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lens	Enfilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Measure Participants	17	17
Measure eyes	17	17
Mean (Standard Deviation) [units on a scale]	2.9 (0.7)	2.6 (1.0)

8. Primary Outcome

Title	Lens Wettability
Description	Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lens	Enfilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Measure Participants	17	17
Measure eyes	17	17
Mean (Standard Deviation) [units on a scale]	2.8 (1.0)	2.8 (0.8)

9. Primary Outcome

Title	Lens Wettability
Description	Lens wettability was assessed on a Grading scale (0-4, 0.25 steps) (0=excellent; 4=severely reduced)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lens	Enfilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: Contact lens	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
Measure Participants	17	17
Measure eyes	17	17
Mean (Standard Deviation) [units on a scale]	2.9 (0.9)	2.6 (1.0)

Adverse Events

Time Frame	From dispense up to one month on study lenses
Arm/Group Title	Sapphire Lens		Enfilcon A
Arm/Group Description	Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. Sapphire Lens: contact lens		Each subject will be randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses will be used in a daily wear modality for one month. enfilcon A: contact lens
All Cause Mortality
	Sapphire Lens		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Serious Adverse Events
	Sapphire Lens		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Sapphire Lens		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (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.