NCT06438601

Completed

A Clinical Comparison of Two Multifocal Toric Soft Contact L...

CooperVision, Inc.Source

CooperVision, Inc.

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

EX-MKTG-159

Study Type

interventional

Actual enrollment (reported)

36

Locations

1 country

Sites

1

Timeline

Study Start

April 24, 2024

Actual (reported)

Primary Completion

August 15, 2024

Actual (reported)

Study Completion

August 15, 2024

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 36 participants
Study completion date: August 15, 2024
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 24, 2024
Actual (reported)
First Submitted
May 24, 2024
Actual (reported)
First Posted
June 3, 2024
Actual (reported)
Primary Completion
August 15, 2024
Actual (reported)
Study Completion
August 15, 2024
Actual (reported)
Results Posted
August 11, 2025
Actual (reported)

Last Updated: August 11, 2025
Status Verified: May 2024
Results QC Date: July 24, 2025
Last Update Submitted: July 24, 2025

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)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age35 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

CooperVision, Inc.
Industrylead

Study Sites (1)

The University of Manchester

Manchester, United Kingdom

MeSH Terms

Conditions

AstigmatismPresbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

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

Study Officials

Carole Maldonado-Codina, PhD,MCOptom
Eurolens Research
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

36 participants (actual enrollment reported by the registry).

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

Actual (reported)

NCT05794126

A Clinical Comparison of Two Soft Multifocal Contact Lenses

Not ApplicableCompleted

NCT05633082

A Clinical Performance of Two Soft Toric Contact Lenses

Not ApplicableCompleted

NCT06490302

Clinical Evaluation of Two Toric Soft Contact Lenses

Not ApplicableCompleted

NCT06758089

A Clinical Comparison of Two Soft Toric Contact Lenses

Not ApplicableCompleted

NCT05734846

Multifocal Contact Lenses Fitting Methods Comparison

Not ApplicableCompleted

NCT05020990

The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

Not ApplicableCompleted

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.

Contact the study team to confirm eligibility.

Primary Completion

August 15, 2024

Actual (reported)

Study Completion

August 15, 2024

Actual (reported)

Last Updated

August 11, 2025

Results First Posted

August 11, 2025

Record last verified: 2024-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06438601
Data provider: ClinicalTrials.gov
Source updated: 2025-08-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:23:30 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2024-03-11

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Lens A (omafilcon A)

Lens B (comfilcon A)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations