Clinical Comparison of Two Soft Contact Lenses

Myopia Clinical Trial

Official title:

A Clinical Comparison of Two Soft Contact Lenses (Iteration Under Umbrella Protocol C19-678)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06251154
• Other study ID #: EX-MKTG-154
• Status: Completed
• Phase: N/A
• Start date: December 11, 2023
• Est. completion date: January 8, 2024

Study information

• Verified date: January 2024
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was designed to gather short-term clinical performance data for 2 soft contact lenses.

Description:

The purpose of this participant-masked, non-randomized, crossover controlled, non-dispensing, study was to compare the short-term performance of 2 daily disposable contact lenses after 15 minutes of daily wear each. The lenses were identical in all aspects except for diameter. Participants attended for 1 visit only which lasted for approximately 2 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 8, 2024
• Est. primary completion date: January 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects will only be eligible for the study if:

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

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

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

4. They were wearing soft contact lenses, or had done so within the past two years.

5. They were able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

• Subjects will not be eligible if:

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

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

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

4. They were aphakic.

5. They had had corneal refractive surgery.

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

7. They were pregnant or lactating.

8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

9. They had taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Lens 1
Daily disposable silicone hydrogel contact lens (diameter=14.0mm) for 15 minutes
• Lens 2
Daily disposable silicone hydrogel contact lens (diameter=14.1mm) for 15 minutes

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	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 Overall Score	Subjective overall score was assessed using 0-100 visual analogue scale, where 0=Extremely poor, unmanageable, cannot use lenses and 100=Excellent, highly impressed with these lenses overall	15 minutes
Secondary	Subjective Comfort	Subjective comfort score was assessed using 0-100 visual analogue scale, where 0=Extremely uncomfortable, causes pain, cannot be tolerated and 100=Excellent, cannot be felt	15 minutes
Secondary	Subjective Vision	Subjective vision score was assessed using a 0-100 visual analogue scale, where 0=Extremely poor, intolerable, lens cannot be worn and 100=Excellent, unaware of any visual loss	15 minutes