Skip to main content
OpenTrials
Completed

NCT Number: NCT06438601

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Manchester

Manchester, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lens A (omafilcon A)

Device

15 minutes of daily wear.

Lens B (comfilcon A)

Device

15 minutes of daily wear.

Primary outcomes

  1. Subjective Distance Vision

    Time frame: At the end of 15 minutes of daily wear

    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).

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.