A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

Myopia Clinical Trial

Official title:

A Clinical Comparison of Three Soft Daily Disposable Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920983
• Other study ID #: EX-MTKG-74 (C16-596)
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: October 2019
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• somofilcon A
contact lens
• nelfilcon A II 2
contact lens
• omafilcon A ll 2
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	Ocular Physiology	Ocular physiology assessment of by biomicroscopy (Scale 0-4, 0.25 steps, 0=normal, 4=severe).	1 week
Secondary	Lens Fit - Horizontal Centration	Horizontal centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal.	1 week
Secondary	Lens Fit - Vertical Centration	Vertical centration will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.	1 week
Secondary	Lens Fit - Corneal Coverage	Corneal coverage will be assessed for the following regions: extremely nasal, slightly nasal, optimum, slightly temporal, extremely nasal.	1 week
Secondary	Lens Fit - Movement	Lens movement assessed using the following evaluations: extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive.	1 week
Secondary	Lens Surface - Deposition	Lens surface will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe	1 week
Secondary	Lens Surface - Wettability	Lens wettability will be assessed using Grades 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe	1 week
Secondary	Visual Acuity	Visual acuity will be assessed by LogMAR.	1 week