The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02920970
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

This study aims to compare the clinical performance and subjective acceptance of the narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable basis.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: narafilcon A; Device: stenfilcon A	N/A

Detailed Description

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Seventy subjects will use each lens type for a week in a random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Dec 22, 2016
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: narafilcon A Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.	Device: narafilcon A; contact lens
Active Comparator: stenfilcon A Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.	Device: stenfilcon A; contact lens

Outcome Measures

Primary Outcome Measures

1. Ocular Physiology [1 week]

   Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

2. Visual Acuity [1 week]

   Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.

3. Comfort Level of Stenfilcon A and Narafilcon A Lenses [1 week]

   Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

4. Dryness of Stenfilcon A and Narafilcon A Lenses [1 week]

   Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).

5. Vision of Stenfilcon A and Narafilcon A Lenses [1 week]

   Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).

6. Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses [1 week]

   Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

7. Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses [1 week]

   Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)

8. Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses [1 week]

   Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

9. Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses [1 week]

   Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

10. Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses [1 week]

    Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

11. Lens Movement [1 week]

    Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects will only be eligible for the study if:

1. They are of legal age (18) and capacity to volunteer.

2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They agree not to participate in other clinical research for the duration of this study.

5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)

6. They have a spectacle cylindrical correction of -0.75D or less in each eye.

7. They can be satisfactorily fitted with the study lens types.

8. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.

9. They currently use soft contact lenses or have done so in the previous six months.

10. They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).

11. They own a wearable pair of spectacles.

Exclusion Criteria:

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

1. They have an ocular disorder which would normally contra-indicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medication such as eye drops or ointment.

4. They have had cataract surgery.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They are pregnant or breast-feeding.

8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.

10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

11. They currently wear either the stenfilcon A lens or narafilcon A lens.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research - The University of Manchester	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Study Director: Philip Morgan, PhD, FAAO, FBCLA, Eurolens Research, University of Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02920970
• Other Study ID Numbers: EX-MKTG-71 (C16-601)
• First Posted: Sep 30, 2016
• Last Update Posted: Jan 16, 2019
• Last Verified: Jul 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	There were 72 participants were enrolled in the study, of which 70 were dispensed a contact lens to wear and 2 failed screening.

Arm/Group Title	Stenfilcon A First Then Narafilcon A	Narafilcon A First Then Stenfilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens first for one week then narafilcon A.	Participants are randomized to wear narafilcon A lens first for one week then stenfilcon A.
Period Title: First Intervention
STARTED	38	32
COMPLETED	38	30
NOT COMPLETED	0	2
Period Title: First Intervention
STARTED	38	30
COMPLETED	37	30
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Overall Number of Baseline Participants
Arm/Group Description	Total number of participants enrolled in the study.
Overall Participants	72
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.8 (11.4)
Sex: Female, Male (Count of Participants)
Female	45 62.5%
Male	27 37.5%

Outcome Measures

1. Primary Outcome

Title	Ocular Physiology
Description	Ocular physiology assessment of narafilcon A and stenfilcon A lenses by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair for one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair for one week during the cross over study.
Measure Participants	68	65
Conjuctival hyperaemia	0.84 (0.25)	0.76 (0.27)
Limbal hyperaemia	0.75 (0.28)	0.62 (0.31)
Corneal vascularisation	0.05 (0.14)	0.03 (0.09)
Microcysts	0.00 (0.00)	0.00 (0.00)
Oedema	0.00 (0.00)	0.00 (0.00)
Corneal staining	0.31 (0.41)	0.33 (0.40)
Conjuctival staining	0.57 (0.49)	0.76 (0.64)
Papillary conjuctivitis	1.01 (0.35)	1.00 (0.31)

2. Primary Outcome

Title	Visual Acuity
Description	Visual acuity for narafilcon A and stenfilcon A are assessed by LogMAR. High contrast is measured with black letters on a white background. Low contrast is measured with gray letters on a white background.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at follow up due to protocol deviations.

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
High Contrast	-0.12 (0.07)	-0.10 (0.08)
Low Contrast	0.17 (0.09)	0.17 (0.10)

3. Primary Outcome

Title	Comfort Level of Stenfilcon A and Narafilcon A Lenses
Description	Subjective responses for overall comfort will be evaluated for each pair using questionnaire (Scale 0-100, 0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Mean (Standard Deviation) [units on a scale]	91.4 (9.8)	83.1 (14.8)

4. Primary Outcome

Title	Dryness of Stenfilcon A and Narafilcon A Lenses
Description	Subjective responses for dryness will be evaluated for each pair using questionnaire (Scale 0-100, 0=extremely poor, high levels of dryness, 100=excellent, no dryness).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Mean (Standard Deviation) [units on a scale]	82.1 (17.2)	81.2 (16.7)

5. Primary Outcome

Title	Vision of Stenfilcon A and Narafilcon A Lenses
Description	Subjective responses for vision will be evaluated for each pair using questionnaire (Scale 0-100, 0=unacceptable, lens cannot be worn, 100=excellent).
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Mean (Standard Deviation) [units on a scale]	91.4 (9.4)	88.4 (14.6)

6. Primary Outcome

Title	Lens Surface - Deposition on Stenfilcon A and Narafilcon A Lenses
Description	Lens surface for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Grade 0	64 88.9%	62 NaN
Grade 1	4 5.6%	5 NaN
Grade 2	0 0%	1 NaN
Grade 3	0 0%	0 NaN
Grade 4	0 0%	0 NaN

7. Primary Outcome

Title	Lens Surface - Wettability of Stenfilcon A and Narafilcon A Lenses
Description	Lens wettability for narafilcon A and stenfilcon A is assessed. (Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe)
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Grade 0	55 76.4%	59 NaN
Grade 1	8 11.1%	5 NaN
Grade 2	4 5.6%	4 NaN
Grade 3	1 1.4%	0 NaN
Grade 4	0 0%	0 NaN

8. Primary Outcome

Title	Lens Fit - Horizontal Centration of Stenfilcon A and Narafilcon A Lenses
Description	Horizontal centration assessed for narafilcon A and stenfilcon A lenses categorized as extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Extremely Nasal	0 0%	0 NaN
Slightly Nasal	0 0%	0 NaN
Optimum	44 61.1%	46 NaN
Slightly Temporal	24 33.3%	22 NaN
Extremely Temporal	0 0%	0 NaN

9. Primary Outcome

Title	Lens Fit - Vertical Centration of Stenfilcon A and Narafilcon A Lenses
Description	Vertical centration assessed for narafilcon A and stenfilcon A lenses and graded as extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Extremely inferior	0 0%	0 NaN
Slightly inferior	11 15.3%	12 NaN
Optimum	42 58.3%	48 NaN
Slightly superior	15 20.8%	8 NaN
Extremely superior	0 0%	0 NaN

10. Primary Outcome

Title	Lens Fit - Corneal Coverage of Stenfilcon A and Narafilcon A Lenses
Description	Corneal coverage will be assessed for narafilcon A and stenfilcon A and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Extremely inadequate	0 0%	0 NaN
Slightly inadequate	4 5.6%	2 NaN
Optimum	56 77.8%	60 NaN
Slighlty excessive	8 11.1%	6 NaN
Extremely excessive	0 0%	0 NaN

11. Primary Outcome

Title	Lens Movement
Description	Lens movement assessed for narafilcon A and senofilcon A lenses and categorized as extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

There were 2 participants excluded from the analysis for narafilcon A at 1 week due to protocol deviations

Arm/Group Title	Stenfilcon A	Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A lens pair and assessed after one week during the cross over study.	Participants are randomized to wear narafilcon A lens pair and assessed after one week during the cross over study.
Measure Participants	68	65
Extremely inadequate	0 0%	0 NaN
Slightly inadequate	3 4.2%	5 NaN
Optimum	55 76.4%	54 NaN
Slightly excessive	10 13.9%	9 NaN
Extremely excessive	0 0%	0 NaN

Adverse Events

Time Frame	1 week
Adverse Event Reporting Description	Adverse events were collected during the study visit exams.
Arm/Group Title	Stenfilcon A		Narafilcon A
Arm/Group Description	Participants are randomized to wear stenfilcon A as the first or second lens pair for one week during the cross over study.		Participants are randomized to wear narafilcon A as the first or second lens pair for one week during the cross over study.
All Cause Mortality
	Stenfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Serious Adverse Events
	Stenfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/70 (0%)		0/70 (0%)
Other (Not Including Serious) Adverse Events
	Stenfilcon A		Narafilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/70 (2.9%)		6/70 (8.6%)
Respiratory, thoracic and mediastinal disorders
Non-ocular Non-Significant	2/70 (2.9%)	2	6/70 (8.6%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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.