A Clinical Comparison of Two Soft Multifocal Contact Lenses

Presbyopia Clinical Trial

Official title:

A Clinical Comparison of Two Soft Multifocal Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05794126
• Other study ID #: C22-726 (EX-MKTG-147)
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: March 23, 2023

Study information

• Verified date: February 2024
• 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 multifocal contact lenses.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: March 23, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 42 Years and older

Eligibility

Inclusion Criteria:

1. They were at least 42 years of age and had 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 had had a full eye examination within the past two years (by self-report).

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

5. They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.

6. They had refractive astigmatism of no greater than -0.75DC.

7. They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.

Exclusion Criteria:

Subjects were not eligible to take part in the study 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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• Lens 1
Soft multifocal hydrogel contact lens for 15 minutes
• Lens 2
Soft multifocal silicone hydrogel contact lens for 15 minutes.

Locations

Country	Name	City	State
United Kingdom	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 Overall Score	Subjective Overall Score was assessed using the 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 the 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 (distance and near) was assessed using the 0-100 visual analogue scale where 0=Unacceptable, cannot be worn and 100=Excellent, unaware of any visual loss	15 Minutes