A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02555098
• Collaborator: (none)
• Enrollment: 23
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Sapphire contact lenses; Device: senofilcon A contact lenses	N/A

Detailed Description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Study Design

• Study Type: Interventional
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sapphire contact lenses Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.	Device: Sapphire contact lenses; Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
Active Comparator: senofilcon A Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.	Device: senofilcon A contact lenses; Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Outcome Measures

Primary Outcome Measures

1. Subjective Ratings for Comfort [Baseline (10 minutes post lens settling)]

   Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

2. Subjective Ratings for Comfort [2 weeks]

   Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)

3. Subjective Ratings for Comfort Preference [Baseline (10 minutes post lens settling)]

   Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

4. Subjective Ratings for Comfort Preference [2 weeks]

   Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference

5. Subjective Assessment of Visual Quality [Baseline (10 minutes post lens settling)]

   Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

6. Subjective Assessment of Visual Quality [2 weeks]

   Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)

7. Subjective Assessment of Overall Satisfaction [Baseline (10 minutes post lens settling)]

   Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

8. Subjective Assessment of Overall Satisfaction [2 weeks]

   Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)

9. Subjective Overall Preference [Baseline (10 minutes post lens settling)]

   Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

10. Subjective Overall Preference [2 weeks]

    Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• A person is eligible for inclusion in the study if they:

1. Are at least 18 years of age and have full legal capacity to volunteer;

2. Have read and signed an information consent letter;

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

4. Are an adapted soft contact lens wearer;

5. Require spectacle lens powers in both eyes;

6. Sphere: between -1.75 to -6.00 diopters and

7. Astigmatism: between -1.00 to -2.25 and

8. Axis: 180 ± 20 degrees

9. Are willing to wear contact lenses in both eyes;

10. Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;

11. 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 including toric orientation as acceptable.

Exclusion Criteria:

• A person will be excluded from the study if they:

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

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

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

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

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

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

7. Are aphakic;

8. Have undergone refractive error surgery;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Family Eye Care Center	Campbell	California	United States	95008

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Michel Guillon, Ocular Technology Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02555098
• Other Study ID Numbers: CV-15-15
• First Posted: Sep 21, 2015
• Last Update Posted: Oct 19, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Astigmatism

Study Results

Participant Flow

Arm/Group Title	Sapphire Test Lenses Then Senofilcon A Lenes	Senofilcon A Then Sapphire Test Lenses
Arm/Group Description	Each subject was randomized to wear the Investigational lenses (test) for two weeks then cross-over to senofilcon A contact lenses (control) for two weeks. Sapphire contact lenses: Contact Lenses Senofilcon A : Contact lenses	Each subject was randomized to wear the senofilcon A contact lenses (control) for two weeks then cross-over to Sapphire lenses (test) for two weeks. Senofilcon A : Contact lenses Sapphire lenses: Contact Lenses
Period Title: First Intervention
STARTED	12	11
COMPLETED	12	11
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	12	11
COMPLETED	12	11
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Each subject randomized to wear either the Sapphire lenses (test) or senofilcon A contact lenses (control) as a matched pair for two weeks and cross over to the second matched pair for two weeks.
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40 (11)
Sex: Female, Male (Count of Participants)
Female	20 87%
Male	3 13%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	23 100%

Outcome Measures

1. Primary Outcome

Title	Subjective Ratings for Comfort
Description	Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Time Frame	Baseline (10 minutes post lens settling)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Sapphire Lenses	Senofilcon A
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire lenses: Contact lenses	Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Measure Participants	22	22
Mean (Standard Deviation) [units on a scale]	89 (14)	80 (20)

2. Primary Outcome

Title	Subjective Ratings for Comfort
Description	Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Sapphire Lenses	Senofilcon A
Arm/Group Description	Each subject randomized to wear the Sapphirel lenses (test) for two weeks. Sapphire lenses: Contact lenses	Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Measure Participants	22	22
Mean (Standard Deviation) [units on a scale]	85 (18)	72 (27)

3. Primary Outcome

Title	Subjective Ratings for Comfort Preference
Description	Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Time Frame	Baseline (10 minutes post lens settling)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Overall Study
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) and senofilcon A contact lenses for two weeks in this cross-over study. Sapphire contact lenses: Contact lenses senofilcon A contact lenses : Contact lenses
Measure Participants	22
Sapphire lens	46 200%
senofilcon A	18 78.3%
No Preference	36 156.5%

4. Primary Outcome

Title	Subjective Ratings for Comfort Preference
Description	Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Overall Study
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) and senofilcon A contact lenses for two weeks in this cross-over study. Sapphire contact lenses: Contact lenses senofilcon A contact lenses : Contact lenses
Measure Participants	22
Sapphire lens	68 295.7%
senofilcon A	27 117.4%
No Preference	5 21.7%

5. Primary Outcome

Title	Subjective Assessment of Visual Quality
Description	Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Time Frame	Baseline (10 minutes post lens settling)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Sapphire Contact Lenses	Senofilcon A
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire contact lenses: Contact lenses	Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Measure Participants	22	22
Mean (Standard Deviation) [units on a scale]	85 (15)	85 (21)

6. Primary Outcome

Title	Subjective Assessment of Visual Quality
Description	Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Sapphire Contact Lenses	Senofilcon A
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire contact lenses: Contact lenses	Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Measure Participants	22	22
Mean (Standard Deviation) [units on a scale]	81 (19)	73 (27)

7. Primary Outcome

Title	Subjective Assessment of Overall Satisfaction
Description	Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Time Frame	Baseline (10 minutes post lens settling)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance

Arm/Group Title	Sapphire Lenses	Senofilcon A
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire contact lenses: Contact lenses	Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Measure Participants	22	22
Mean (Standard Deviation) [units on a scale]	89 (12)	81 (21)

8. Primary Outcome

Title	Subjective Assessment of Overall Satisfaction
Description	Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance

Arm/Group Title	Sapphire Contact Lenses	Senofilcon A
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire contact lenses: Contact lenses	Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
Measure Participants	22	22
Mean (Standard Deviation) [units on a scale]	87 (14)	73 (30)

9. Primary Outcome

Title	Subjective Overall Preference
Description	Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Time Frame	Baseline (10 minutes post lens settling)

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Overall Study
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) and senofilcon A contact lenses for two weeks in this cross-over study. Sapphire contact lenses: Contact lenses senofilcon A contact lenses : Contact lenses
Measure Participants	22
Sapphire Lens	55 239.1%
No Preference	18 78.3%
senofilcon A	27 117.4%

10. Primary Outcome

Title	Subjective Overall Preference
Description	Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

One subject was excluded from the analysis due to compliance.

Arm/Group Title	Overall Study
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) and senofilcon A contact lenses for two weeks in this cross-over study. Sapphire contact lenses: Contact lenses senofilcon A contact lenses : Contact lenses
Measure Participants	22
Sapphire Lens	73 317.4%
No Preference	4 17.4%
senofilcon A	23 100%

Adverse Events

Time Frame	From dispense up to 2 weeks on each study lenses, a total of 4 weeks.
Arm/Group Title	Sapphire Contact Lenses		Senofilcon A
Arm/Group Description	Each subject randomized to wear the Sapphire lenses (test) for two weeks. Sapphire contact lenses: Contact lenses		Each subject randomized to wear senofilcon A contact lenses (control) for two weeks. senofilcon A contact lenses: Contact lenses
All Cause Mortality
	Sapphire Contact Lenses		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Serious Adverse Events
	Sapphire Contact Lenses		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Sapphire Contact Lenses		Senofilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/23 (0%)		0/23 (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.