A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02920983
• Collaborator: (none)
• Enrollment: 51
• Location: 1
• Arms: 3
• Duration (Months): 5
• Patients Per Site Per Month: 10.1

Study Details

Study Description

Brief Summary

This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: somofilcon A; Device: nelfilcon A II 2; Device: omafilcon A ll 2	N/A

Detailed Description

This will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. Fifty subjects will use each lens type for a week in 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: 51 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Feb 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: somofilcon A Subjects are randomized to wear somofilcon A for one week during the cross over study.	Device: somofilcon A; contact lens
Active Comparator: nelfilcon A II 2 Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study.	Device: nelfilcon A II 2; contact lens
Active Comparator: omafilcon A ll 2 Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study.	Device: omafilcon A ll 2; contact lens

Outcome Measures

Primary Outcome Measures

1. Ocular Physiology [1 week]

   Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).

Secondary Outcome Measures

1. Lens Fit - Horizontal Centration [1 week]

   Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.

2. Lens Fit - Vertical Centration [1 week]

   Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

3. Lens Fit - Corneal Coverage [1 week]

   Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.

4. Lens Fit - Movement [1 week]

   Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.

5. Lens Surface - Deposition [1 week]

   Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

6. Lens Surface - Wettability [1 week]

   Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe

7. Visual Acuity [1 week]

   Visual acuity will be assessed by LogMAR.

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. 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.

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

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

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.

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

• Principal Investigator: Carole Maldonado-Codinal, PhD, FAAO, Eurolens Research, University of Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT02920983
• Other Study ID Numbers: EX-MTKG-74 (C16-596)
• First Posted: Sep 30, 2016
• Last Update Posted: Oct 17, 2019
• Last Verified: Oct 1, 2019

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

Study Results

Participant Flow

Recruitment Details	55 subjects were recruited for the study, 51 subjects were enrolled and 50 subjects completed the initial follow up visit.
Pre-assignment Detail	Subjects are randomized to wear each lens brand for one week in a random sequence.

Arm/Group Title	Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2	Somofilcon A, Omafilcon A II 2, Nelfilcon A II 2	Nelfilcon A II 2, Somofilcon A, Omafilcon A II 2	Nelfilcon A II 2, Omafilcon A II 2, Somofilcon A	Omafilcon A II 2, Nelficon A II 2, Somofilcon A	Omafilcon A II 2, Somofilcon A, Nelfilcon A II 2
Arm/Group Description	Subjects are randomized to wear somofilcon A pair of lenses for one week during the crossover study then nelfilcon A II2, then omafilcon A II 2 lenses for one week each.	Subjects are randomized to wear somofilcon A pair of lenses for one week during the cross-over study then omafilcon A II 2, then nelfilcon A II 2 lenses for one week each.	Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then Omafilcon A II 2 lenses for one week each.	Subjects are randomized to wear nelfilcon A II 2 pair of lenses for one week during the cross-over study then Omafilcon A II 2, then Somofilcon A, lenses for one week each.	Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then nelfilcon A II 2, then Somofilcon A lenses for one week each.	Subjects are randomized to wear omafilcon A II 2 pair of lenses for one week during the cross-over study then Somofilcon A, then nelfilcon A II 2 lenses for one week each.
Period Title: Dispense 1
STARTED	8	10	7	6	13	7
COMPLETED	8	10	7	6	12	7
NOT COMPLETED	0	0	0	0	1	0
Period Title: Dispense 1
STARTED	8	10	7	6	13	7
COMPLETED	7	10	7	6	12	7
NOT COMPLETED	1	0	0	0	1	0
Period Title: Dispense 1
STARTED	8	10	7	6	13	7
COMPLETED	7	9	7	6	12	7
NOT COMPLETED	1	1	0	0	1	0

Baseline Characteristics

Arm/Group Title	Overall Study
Arm/Group Description	Total participants
Overall Participants	55
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.6 (12.9)
Sex: Female, Male (Count of Participants)
Female	35 63.6%
Male	20 36.4%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
Conjunctival Hyperemia	0.76 (0.26)	0.79 (0.31)	0.78 (0.28)
Limbal Hyperaemia	0.63 (0.24)	0.66 (0.30)	0.65 (0.28)
Corneal Vascularization	0.05 (0.11)	0.05 (0.10)	0.06 (0.09)
Microcysts	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
Oedema	0.00 (0.00)	0.00 (0.00)	0.00 (0.00)
Corneal Staining	0.33 (0.42)	0.42 (0.43)	0.26 (0.36)
Conjunctival Staining	1.37 (0.65)	0.41 (0.43)	0.23 (0.20)
Paipliiary Conjunctivitis	0.95 (0.28)	0.88 (0.35)	0.93 (0.34)

2. Secondary Outcome

Title	Lens Fit - Horizontal Centration
Description	Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
Extremely Nasal	0 0%	0 NaN	0 NaN
Slightly Nasal	1 1.8%	3 NaN	1 NaN
Optimum	28 50.9%	28 NaN	26 NaN
Slightly Temporal	20 36.4%	17 NaN	22 NaN
Extremely Temporal	0 0%	0 NaN	0 NaN

3. Secondary Outcome

Title	Lens Fit - Vertical Centration
Description	Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
Extremely Nasal	0 0%	0 NaN	0 NaN
Slightly Nasal	11 20%	20 NaN	22 NaN
Optimum	21 38.2%	22 NaN	22 NaN
Slightly Temporal	17 30.9%	6 NaN	5 NaN
Extremely Temporal	0 0%	0 NaN	0 NaN

4. Secondary Outcome

Title	Lens Fit - Corneal Coverage
Description	Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
Extremely Nasal	0 0%	0 NaN	0 NaN
Slightly Nasal	3 5.5%	7 NaN	4 NaN
Optimum	46 83.6%	39 NaN	41 NaN
Slightly Temporal	0 0%	2 NaN	4 NaN
Extremely Temporal	0 0%	0 NaN	0 NaN

5. Secondary Outcome

Title	Lens Fit - Movement
Description	Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
Extremely inadequate	0 0%	0 NaN	0 NaN
Slightly inadequate	3 5.5%	19 NaN	12 NaN
Optimum	38 69.1%	27 NaN	27 NaN
Slightly excessive	8 14.5%	2 NaN	9 NaN
Extremely excessive	0 0%	0 NaN	1 NaN

6. Secondary Outcome

Title	Lens Surface - Deposition
Description	Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
Grade 0	46 83.6%	47 NaN	48 NaN
Grade 1	3 5.5%	1 NaN	1 NaN
Grade 2	0 0%	0 NaN	0 NaN
Grade 3	0 0%	0 NaN	0 NaN
Grade 4	0 0%	0 NaN	0 NaN

7. Secondary Outcome

Title	Lens Surface - Wettability
Description	Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
Grade 0	37 67.3%	44 NaN	43 NaN
Grade 1	9 16.4%	3 NaN	3 NaN
Grade 2	3 5.5%	1 NaN	3 NaN
Grade 3	0 0%	0 NaN	0 NaN
Grade 4	0 0%	0 NaN	0 NaN

8. Secondary Outcome

Title	Visual Acuity
Description	Visual acuity will be assessed by LogMAR.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

Protocol deviations and discontinuations account for difference in analysis population

Arm/Group Title	Somofilcon A	Nelfilcon A II 2	Omafilcon A ll 2
Arm/Group Description	Subjects are randomized to wear somofilcon A for one week during the cross over study. somofilcon A: contact lens	Subjects are randomized to wear nelfilcon A II 2 for one week during the cross over study. nelfilcon A II 2: contact lens	Subjects are randomized to wear omafilcon A ll 2 for one week during the cross over study. omafilcon A ll 2: contact lens
Measure Participants	49	48	49
High Contrast	-0.11 (0.08)	-0.13 (0.08)	-0.11 (0.07)
Low Contrast	0.18 (0.10)	0.17 (0.11)	0.18 (0.10)

Adverse Events

Time Frame	Subjects were randomized to wear each pair of lenses (Somofilcon A, Nelfilcon A II 2, Omafilcon A II 2 at a random sequence) for One- Week in a random sequence, assessed overall for up to 4 weeks.
Arm/Group Title	Somofilcon A		Nelfilcon A II 2		Omafilcon A II 2
Arm/Group Description	Subjects are randomized to wear Somofilcon A for one week at random sequence		Subjects are randomized to wear Nelfilcon A II 2 for one week at random sequence		Subjects are randomized to wear Omafilcon A II 2 for one week at random sequence
All Cause Mortality
	Somofilcon A		Nelfilcon A II 2		Omafilcon A II 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/48 (0%)		0/49 (0%)
Serious Adverse Events
	Somofilcon A		Nelfilcon A II 2		Omafilcon A II 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/49 (0%)		0/48 (0%)		0/49 (0%)
Other (Not Including Serious) Adverse Events
	Somofilcon A		Nelfilcon A II 2		Omafilcon A II 2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/49 (8.2%)		3/48 (6.3%)		4/49 (8.2%)
Infections and infestations
Common cold	4/49 (8.2%)	4	3/48 (6.3%)	3	4/49 (8.2%)	4

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.