Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03235115
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 3
• Actual Duration (Months): 3
• Patients Per Site Per Month: 13.4

Study Details

Study Description

Brief Summary

This study aims to compare the short-term clinical performance of the three contact lenses (Methafilcon A IV, Ocufilcon B 1-day and Omafilcon A 1-day daily disposable).

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Methafilcon A IV; Device: Ocufilcon B; Device: Omafilcon A	N/A

Detailed Description

This will be a randomized, double-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Forty subjects will wear each lens brand for approximately one hour, on three separate study days in random order. Lenses will only be worn during study visits.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Fitting Evaluation of Hydrogel and Silicone Hydrogel Spherical Contact Lenses
• Actual Study Start Date: Jun 23, 2017
• Actual Primary Completion Date: Sep 22, 2017
• Actual Study Completion Date: Sep 22, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Methafilcon A IV Subjects are randomized to wear Methafilcon A IV for 1 hour during the cross over study.	Device: Ocufilcon B; Contact Lens; Device: Omafilcon A; Contact Lens
Active Comparator: Ocufilcon B Subjects are randomized to wear Ocufilcon B for 1 hour during the cross over study.	Device: Methafilcon A IV; Contact Lens; Device: Omafilcon A; Contact Lens
Active Comparator: Omafilcon A Subjects are randomized to wear Omafilcon A for 1 hour during the cross over study.	Device: Methafilcon A IV; Contact Lens; Device: Ocufilcon B; Contact Lens

Outcome Measures

Primary Outcome Measures

1. Visual Acuity Using logMAR [Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn]

   Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction

2. Lens Fit - Horizontal Centration [Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn]

   Assessment of horizontal centration of lens on eye

3. Lens Fit - Vertical Centration [Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn]

   Assessment of vertical centration of lens on eye

4. Lens Fit - Corneal Coverage of Lens [Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn]

   Assessment of corneal coverage of lens on eye

5. Lens Fit - Movement of Lens [Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn]

   Assessment of movement of lens on eye

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• They are of aged 18-40 and have capacity to volunteer.

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

• They are willing and able to follow the protocol.

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

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

• They have a spectacle cylindrical correction of -0.75D or less in each eye (based on the ocular refraction).

• 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.

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

Exclusion Criteria:

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

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

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

• They have had cataract surgery.

• They have had corneal refractive surgery.

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

• They are pregnant or lactating.

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

• 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.

• 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

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 15, 2017

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT03235115
• Other Study ID Numbers: EX-MKTG-85
• First Posted: Aug 1, 2017
• Last Update Posted: Sep 12, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Seizures; Myopia

Study Results

Participant Flow

Arm/Group Title	Methafilcon A IV, Ocufilcon B, Omafilcon A	Methafilcon A IV, Omafilcon A, Ocufilcon B	Ocufilcon B, Omafilcon A, Methafilcon A IV	Ocufilcon B, Methafilcon A IV, Omafilcon A	Omafilcon A, Ocufilcon B, Methafilcon A IV	Omafilcon A, Methafilcon A IV, Ocufilcon B
Arm/Group Description	Subjects randomized to wear Methafilcon A IV first, then Ocufilcon B, then Omafilcon A contact lens	Subjects randomized to wear Methafilcon A IV first, then Omafilcon A, then Ocufilcon B contact lens	Subjects randomized to wear Ocufilcon B first, then Omafilcon A, then Methafilcon A IV contact lens	Subjects randomized to wear Ocufilcon B first, then Methafilcon A IV, then Omafilcon A contact lens	Subjects randomized to wear Omafilcon A first, then Ocufilcon B, then Methafilcon A IV contact lens	Subjects randomized to wear Omafilcon A first, then Methafilcon A IV, then Ocufilcon B contact lens
Period Title: First Intervention (1 Hour, Visit 2)
STARTED	9	6	7	6	6	6
COMPLETED	9	6	7	6	6	5
NOT COMPLETED	0	0	0	0	0	1
Period Title: First Intervention (1 Hour, Visit 2)
STARTED	9	6	7	6	6	5
COMPLETED	9	6	7	6	6	5
NOT COMPLETED	0	0	0	0	0	0
Period Title: First Intervention (1 Hour, Visit 2)
STARTED	9	6	7	6	6	5
COMPLETED	9	6	7	6	6	5
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants were randomized to wear each of the 3 different contact lens pairs
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.0 (6.4)
Sex: Female, Male (Count of Participants)
Female	26 65%
Male	14 35%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Visual Acuity Using logMAR
Description	Assessment of visual performance using the Bailey-Lovie logMAR visual acuity test chart and procedures for carrying out an over-refraction
Time Frame	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omafilcon A	Methafilcon A IV	Ocufilcon B
Arm/Group Description	Subjects who wore Omafilcon A for 1 hour during the cross over study.	Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.	Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
Measure Participants	40	39	39
At Dispense	-0.14 (0.09)	-0.13 (0.07)	-0.13 (0.07)
Follow Up	-0.14 (0.07)	-0.14 (0.07)	-0.14 (0.07)

2. Primary Outcome

Title	Lens Fit - Horizontal Centration
Description	Assessment of horizontal centration of lens on eye
Time Frame	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omafilcon A	Methafilcon A IV	Ocufilcon B
Arm/Group Description	Subjects who wore Omafilcon A for 1 hour during the cross over study.	Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.	Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
Measure Participants	40	39	39
Extremely nasal	0 0%	0 NaN	0 NaN
Slightly nasal	1 2.5%	1 NaN	1 NaN
Optimum	23 57.5%	17 NaN	26 NaN
Slightly temporal	16 40%	21 NaN	12 NaN
Extremely temporal	0 0%	0 NaN	0 NaN
Extremely nasal	0 0%	0 NaN	0 NaN
Slightly nasal	1 2.5%	2 NaN	0 NaN
Optimum	22 55%	14 NaN	26 NaN
Slightly temporal	17 42.5%	22 NaN	13 NaN
Extremely temporal	0 0%	1 NaN	0 NaN

3. Primary Outcome

Title	Lens Fit - Vertical Centration
Description	Assessment of vertical centration of lens on eye
Time Frame	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omafilcon A	Methafilcon A IV	Ocufilcon B
Arm/Group Description	Subjects who wore Omafilcon A for 1 hour during the cross over study.	Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.	Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
Measure Participants	40	39	39
Extremely inferior	0 0%	0 NaN	0 NaN
Slightly inferior	12 30%	6 NaN	9 NaN
Optimum	20 50%	9 NaN	27 NaN
Slightly superior	8 20%	24 NaN	3 NaN
Extremely superior	0 0%	0 NaN	0 NaN
Extremely inferior	0 0%	0 NaN	0 NaN
Slightly inferior	15 37.5%	4 NaN	11 NaN
Optimum	18 45%	14 NaN	26 NaN
Slightly superior	7 17.5%	21 NaN	2 NaN
Extremely superior	0 0%	0 NaN	0 NaN

4. Primary Outcome

Title	Lens Fit - Corneal Coverage of Lens
Description	Assessment of corneal coverage of lens on eye
Time Frame	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omafilcon A	Methafilcon A IV	Ocufilcon B
Arm/Group Description	Subjects who wore Omafilcon A for 1 hour during the cross over study.	Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.	Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
Measure Participants	40	39	39
Extremely inadequate	0 0%	0 NaN	0 NaN
Slightly inadequate	6 15%	16 NaN	4 NaN
Optimum	29 72.5%	22 NaN	30 NaN
Slightly excessive	5 12.5%	1 NaN	5 NaN
Extremely excessive	0 0%	0 NaN	0 NaN
Extremely inadequate	0 0%	1 NaN	0 NaN
Slightly inadequate	5 12.5%	13 NaN	4 NaN
Optimum	30 75%	24 NaN	30 NaN
Slightly excessive	5 12.5%	1 NaN	5 NaN
Extremely excessive	0 0%	0 NaN	0 NaN

5. Primary Outcome

Title	Lens Fit - Movement of Lens
Description	Assessment of movement of lens on eye
Time Frame	Dispense and follow-up, approximately one hour (1hr) of lens wear for each lens type worn

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Omafilcon A	Methafilcon A IV	Ocufilcon B
Arm/Group Description	Subjects who wore Omafilcon A for 1 hour during the cross over study.	Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.	Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
Measure Participants	40	39	39
Extremely inadequate	0 0%	0 NaN	0 NaN
Slightly inadequate	1 2.5%	7 NaN	8 NaN
Optimum	24 60%	25 NaN	16 NaN
Slightly excessive	15 37.5%	7 NaN	15 NaN
Extremely excessive	0 0%	0 NaN	0 NaN
Extremely inadequate	0 0%	0 NaN	0 NaN
Slightly inadequate	2 5%	2 NaN	1 NaN
Optimum	23 57.5%	28 NaN	19 NaN
Slightly excessive	15 37.5%	9 NaN	19 NaN
Extremely excessive	0 0%	0 NaN	0 NaN

Adverse Events

Time Frame	Patients wore 3 different contact lenses for 1 hour on 3 different days
Arm/Group Title	Omafilcon A		Methafilcon A IV		Ocufilcon B
Arm/Group Description	Subjects who wore Omafilcon A for 1 hour during the cross over study.		Subjects who wore Methafilcon A IV for 1 hour as one of the 3 lenses in this crossover study.		Subjects who wore Ocufilcon B for 1 hour as one of the 3 lenses in this crossover study.
All Cause Mortality
	Omafilcon A		Methafilcon A IV		Ocufilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)		0/39 (0%)
Serious Adverse Events
	Omafilcon A		Methafilcon A IV		Ocufilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Omafilcon A		Methafilcon A IV		Ocufilcon B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)		0/39 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Disclosure restriction on the PI is that the sponsor should be notified of any use of data for results communication.