A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses

NCT06438601 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-159
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the short-term clinical performance of the two study contact lenses.

Conditions

Astigmatism; Presbyopia

Outcome Measures

Primary Outcomes (1)

• Subjective Distance Vision

  Subjective Distance Vision will be measured on a scale from 0-100 (Where 0= Extremely poor. Intolerable. Lenses cannot be worn. 100= Excellent. Unaware of any visual loss).

  At the end of 15 minutes of daily wear

Study Arms (2)

Lens A (omafilcon A)

EXPERIMENTAL

All participants will wear lens A for 15 minutes (Period 1).

Device: Lens A (omafilcon A)

Lens B (comfilcon A)

EXPERIMENTAL

All participants will wear lens B for 15 minutes (Period 2).

Device: Lens B (comfilcon A)

Interventions

Lens A (omafilcon A) DEVICE

15 minutes of daily wear.

Lens A (omafilcon A)

Lens B (comfilcon A) DEVICE

15 minutes of daily wear.

Lens B (comfilcon A)

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They are aged 35 years or over and have capacity to volunteer.
• They understand their rights as a subject and are willing to sign a Statement of Informed Consent.
• They are willing and able to follow the protocol.
• They agree not to participate in other clinical research for the duration of this study.
• They are currently wearing soft contact lenses or have done so within the past 12 months.
• They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction).
• They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye.
• They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS.
• They can be satisfactorily fitted with the study lenses.
• They own a wearable pair of spectacles.

You may not qualify if:

• They have an ocular disorder which would normally contraindicate contact lens wear.
• They have a systemic disorder which would normally contra-indicate contact lens wear.
• They are using any topical medications such as eye drops or ointment.
• They have had cataract surgery.
• They have had corneal refractive surgery.
• They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
• They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
• They have eye or health conditions including immunosuppressive or infectious diseases 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

The University of Manchester

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Astigmatism; Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

javega@coopervision.com

925-621-3761

Study Officials

• Carole Maldonado-Codina, PhD,MCOptom

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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: May 24, 2024
• First Posted: June 3, 2024
• Study Start: April 24, 2024
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: August 11, 2025
• Results First Posted: August 11, 2025

Record last verified: 2024-05

Locations

GB (1)