A 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: NCT05741450
• Other study ID #: C22-724 (EX-MKTG-138)
• Status: Completed
• Phase: N/A
• Start date: November 24, 2022
• Est. completion date: December 5, 2022

Study information

• Verified date: February 2023
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective was to gather short-term clinical performance data for two soft contact lenses.

Description:

The aim of this subject-masked, non-randomized, controlled non-dispensing study was to evaluate the short-term clinical performance of a monthly sphere contact lens when compared to a daily disposable contact lens after 15 minutes of daily wear each.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• They are of legal age (18) and 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 currently wear soft contact lenses, or have done so within the past two years.
• They are expected to be able to be fitted with the study lenses within the power range available.

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 lactating.
• They have an eye or health condition including an immunosuppressive or infectious disease which would, 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.
• They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Related Conditions & MeSH terms

• Hyperopia
• Myopia

Intervention

Device:
• Lens 1 (monthly replacement)
Monthly replacement spherical silicone hydrogel contact lens for 15 minutes
• Lens 2 (daily disposable)
Daily disposable spherical silicone hydrogel contact lens 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, 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=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=Unacceptable, lens cannot be worn and 100=Excellent, unaware of any visual loss	15 minutes