A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses

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

Study Overview

• Status: Completed
• Conditions: Presbyopia; Astigmatism
• Intervention / Treatment: Device: Lens B (comfilcon A); Device: Lens A (omafilcon A)

Detailed Description

The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom
    • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. They have an ocular disorder which would normally contraindicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medications such as eye drops or ointment.
4. They have had cataract surgery.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
8. 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.
9. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens B (comfilcon A); All participants will wear lens B for 15 minutes (Period 2).	Device: Lens B (comfilcon A); 15 minutes of daily wear.
Experimental: Lens A (omafilcon A); All participants will wear lens A for 15 minutes (Period 1).	Device: Lens A (omafilcon A); 15 minutes of daily wear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Carole Maldonado-Codina, PhD,MCOptom, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Actual): August 15, 2024
• Study Completion (Actual): August 15, 2024

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Presbyopia
• Other Study ID Numbers: EX-MKTG-159

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes