A Clinical Comparison of Two Soft Multifocal Contact Lenses

NCT05794126 | Completed Results FDA Device

• 1 other identifier: C22-726 (EX-MKTG-147)
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subjective Comfort

  15 Minutes

• Subjective Vision

  15 Minutes

Study Arms (2)

Lens 1

EXPERIMENTAL

Participants wore Lens 1 for 15 minutes (Period 1)

Device: Lens 1

Lens 2

EXPERIMENTAL

Participants wore Lens 2 for 15 minutes (Period 2)

Device: Lens 2

Interventions

Lens 1 DEVICE

Soft multifocal hydrogel contact lens for 15 minutes

Lens 1

Lens 2 DEVICE

Soft multifocal silicone hydrogel contact lens for 15 minutes.

Lens 2

Eligibility Criteria

• Age: 42 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They were at least 42 years of age and had capacity to volunteer.
• They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
• They had had a full eye examination within the past two years (by self-report).
• They were willing and able to follow the protocol.
• 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.
• They had refractive astigmatism of no greater than -0.75DC.
• 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.

You may not qualify if:

• Subjects were not eligible to take part in the study if:
• They had an ocular disorder which would normally contra-indicate contact lens wear.
• They had a systemic disorder which would normally contra-indicate contact lens wear.
• They were using any topical medication such as eye drops or ointment.
• They were aphakic.
• They had had corneal refractive surgery.
• They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
• They were pregnant or lactating.
• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

The University of Manchester

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: José A. Vega OD, PhD, MSc, FAAO
• Organization: CooperVision Inc.

jvega2@coopervision.com

+19256213761

Study Officials

• Philip Morgan, PhD, MCOptom

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: February 1, 2023
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-02

Locations

GB (1)