A Clinical Comparison of Two Soft Multifocal Contact Lenses

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Lens 1; Device: Lens 2

• Registration Number: NCT05794126
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Primary Completion: 2023-03-23
• Study Completion: 2023-03-23
• Study First Posted: 2023-04-03
• Status Verified: 2024-02
• Results First Submitted: 2024-03-12
• Results First Submitted QC: 2024-03-12
• Last Update Submitted: 2024-03-12
• Results First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens 1	Lens 1	Participants wore Lens 1 for 15 minutes (Period 1)
Lens 2	Lens 2	Participants wore Lens 2 for 15 minutes (Period 2)

Primary Outcome Measures

Name	Time	Method
Subjective Overall Score	15 Minutes	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

Secondary Outcome Measures

Name	Time	Method
Subjective Vision	15 Minutes	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
Subjective Comfort	15 Minutes	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

Trial Locations

Locations (1)

The University of Manchester; 🇬🇧 Manchester, United Kingdom