A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses

Not Applicable

Active, not recruiting

• Conditions: Presbyopia; Astigmatism
• Interventions: Device: Lens A (omafilcon A); Device: Lens B (comfilcon A)

• Registration Number: NCT06438601
• Lead Sponsor: Coopervision, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2024-04-25
• Status Verified: 2024-05
• Study First Submitted: 2024-05-24
• Study First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Study First Posted: 2024-06-03
• Last Update Posted: 2024-06-03
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lens A (omafilcon A)	Lens A (omafilcon A)	All participants will wear lens A for 15 minutes (Period 1).
Lens B (comfilcon A)	Lens B (comfilcon A)	All participants will wear lens B for 15 minutes (Period 2).

Primary Outcome Measures

Name	Time	Method
Subjective Distance Vision	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).

Trial Locations

Locations (1)

The University of Manchester; 🇬🇧 Manchester, United Kingdom