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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02518490
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 9

Study Details

Study Description

Brief Summary

This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.

The study results were not used for design validation of test lens.

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

Detailed Description

Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month.

The study results were not used for design validation of test lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sapphire lens Each subject will be randomized to wear the test lens on one eye and control lens on one eye.	Device: Sapphire Lens; Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
Active Comparator: enfilcon A Each subject will be randomized to wear the test lens on one eye and control lens on one eye.	Device: enfilcon A; Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Outcome Measures

Primary Outcome Measures

1. Subjective Ratings for Comfort After Lens Insertion [Baseline (5 minutes post lens dispensing)]

   Subjective ratings for 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 for Comfort After Lens Insertion [4 weeks]

   Subjective ratings for 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. Percentage of Participants With a Lens Preference Based on Subjective Comfort [Baseline (5 minutes post lens dispensing)]

   Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference

4. Percentage of Participants With a Lens Preference Based on Subjective Comfort [4 weeks]

   Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference

5. Lens Wettability [Baseline (5 minutes post lens dispensing)]

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

6. Lens Wettability [4 weeks]

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

7. Lens Surface Deposition [Baseline (5 minutes post lens dispensing)]

   Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)

8. Lens Surface Deposition [4 weeks]

   Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects will only be eligible for the study if:

1. Is at least 18 years of age for the USA and has full legal capacity to volunteer;

2. Has read and signed an information consent letter;

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

4. Is an adapted soft contact lens wearer;

5. Requires spectacle lens powers between -0.50 to -6.50 diopters sphere;

6. Has no more than 0.75 diopters of refractive astigmatism;

7. Willing to wear contact lens in both eyes;

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

9. To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable.

Exclusion Criteria:

• Subjects will not be eligible to take part in the study if:

1. Is participating in any concurrent clinical or research study;

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

3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;

4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;

5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);

7. Is aphakic;

8. Has undergone refractive error 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Research Center, University of California, Berkeley	Berkeley	California	United States	94704

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Meng Lin, Clinical Research Center, University of California, Berkeley

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02518490
• Other Study ID Numbers: CV-15-46
• First Posted: Aug 7, 2015
• Last Update Posted: Sep 22, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Arm/Group Title	Sapphire Lenses	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 Lenses	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 lenses
Period Title: Overall Study
STARTED	18	18
COMPLETED	17	17
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period.
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]	29 (12)
Sex: Female, Male (Count of Participants)
Female	14 82.4%
Male	3 17.6%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	17 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Ratings for Comfort After Lens Insertion
Description	Subjective ratings for 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 (5 minutes post lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lenses	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 Lenses	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 lenses
Measure Participants	17	17
Measure Eyes	17	17
Mean (Standard Deviation) [units on a scale]	91 (11)	93 (12)

2. Primary Outcome

Title	Subjective Ratings for Comfort After Lens Insertion
Description	Subjective ratings for 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 Lenses	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 Lenses	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 lenses
Measure Participants	17	17
Measure Eyes	17	17
Mean (Standard Deviation) [units on a scale]	88 (11)	87 (15)

3. Primary Outcome

Title	Percentage of Participants With a Lens Preference Based on Subjective Comfort
Description	Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Time Frame	Baseline (5 minutes post lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period. Sapphire Test lens: Contact lens Enfilcon A: contact lens
Measure Participants	17
Sapphire	20 117.6%
No preference	30 176.5%
enfilcon A	50 294.1%

4. Primary Outcome

Title	Percentage of Participants With a Lens Preference Based on Subjective Comfort
Description	Percentage of Participants with a Lens Preference Based on Subjective Comfort. Preferred Sapphire, Preferred Enfilcon A, No preference
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall Study
Arm/Group Description	Subjects were randomized to wear test lens in one eye and control lens in other eye for a one month period. Sapphire Test lens: Contact lens Enfilcon A: contact lens
Measure Participants	17
Sapphire	10 58.8%
No preference	65 382.4%
enfilcon A	25 147.1%

5. 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 (5 minutes post lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lenses	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 Lenses	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 lenses
Measure Participants	17	17
Measure Eyes	17	17
Mean (Standard Deviation) [units on a scale]	3.4 (0.4)	3.4 (0.3)

6. 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 Lenses	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 Lenses	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 lenses
Measure Participants	17	17
Measure Eyes	17	17
Mean (Standard Deviation) [units on a scale]	3.5 (0.4)	3.6 (0.3)

7. Primary Outcome

Title	Lens Surface Deposition
Description	Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time Frame	Baseline (5 minutes post lens dispensing)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lenses	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 Lenses	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 lenses
Measure Participants	17	17
Measure Eyes	17	17
Mean (Standard Deviation) [units on a scale]	0.06 (0.17)	0.03 (0.12)

8. Primary Outcome

Title	Lens Surface Deposition
Description	Lens Surface Deposit was assessed on a scale of 0-4 (0-4, 0.25 steps)(0- Clean , no deposits, 1- 5 or less small deposits (<0.1mm), 2- >5 deposits of <0.1mm size or film covering 25-50% of surface, 3 - Deposits of between 0.1 and 0.5amm or film covering 50-75% of surface, 4- Deposits of 0.5mm or larger or film covering more than 75% of surface)
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sapphire Lenses	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 Lenses	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 lenses
Measure Participants	17	17
Measure Eyes	17	17
Mean (Standard Deviation) [units on a scale]	0.21 (0.50)	0.10 (0.27)

Adverse Events

Time Frame	From dispense up to 4 weeks on the study lenses.
Arm/Group Title	Sapphire Lenses		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 Lenses		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 lenses
All Cause Mortality
	Sapphire Lenses		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Serious Adverse Events
	Sapphire Lenses		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Sapphire Lenses		Enfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (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.