A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Myopia Clinical Trial

Official title:

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005885
• Other study ID #: EX-MKTG-100
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: December 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Description:

This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 30, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Subjects will only be eligible for the study if:

• They are between 18 and 40 years of age (inclusive).

• 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 are an existing soft reusable spherical contact lens wearer in both eyes.

• They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.

• They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction

• They own a wearable pair of spectacles and wear them on the day of the initial visit.

• They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.

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

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 are aphakic.

• 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 breastfeeding.

• 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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• comfilcon A
Contact Lens
• somofilcon A
daily disposable contact lens
• stenfilcon A
daily disposable contact lens

Locations

Country	Name	City	State
United Kingdom	Eurolens Research - The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use	Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	4 weeks
Primary	Subjective Scores of Comfort on Insertion	Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	1 week
Secondary	Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use	Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	4 weeks
Secondary	Subjective Scores on Overall Comfort	Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	1 week
Secondary	Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use	Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	4 weeks
Secondary	Subjective Scores on Comfort Before Removal	Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).	1 week
Secondary	Number of Participants With Horizontal Lens Centration Grade	Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)	Baseline (after 5 minutes of lens dispense)
Secondary	Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear	Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)	4 weeks
Secondary	Number of Participants With Horizontal Lens Centration Grade	Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)	1 week
Secondary	Number of Participants With Vertical Lens Centration Grade	Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)	Baseline (After 5 minutes of lens dispense)
Secondary	Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear	Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)	4 weeks
Secondary	Number of Participants With Vertical Lens Centration Grade	Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)	1 week
Secondary	Number of Participants With Lens Corneal Coverage Grade	Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)	Baseline (after 5 minutes of lens dispense)
Secondary	Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear	Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)	4 weeks
Secondary	Number of Participants With Lens Corneal Coverage Grade	Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)	1 week
Secondary	Number of Participants With Post-Blink Movement Grade	Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)	Baseline (after 5 minutes of lens dispense)
Secondary	Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear	Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)	4 weeks
Secondary	Number of Participants With Post-Blink Movement Grade	Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)	1 week
Secondary	Investigator Lens Fit Acceptance	Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)	Baseline (after 5 minutes of lens dispense)
Secondary	Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use	Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)	4 weeks
Secondary	Investigator Lens Fit Acceptance	Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)	1 week