A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses

Presbyopia Clinical Trial

Official title:

A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06438601
• Other study ID #: EX-MKTG-159
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 25, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Presbyopia

Intervention

Device:
• Lens A (omafilcon A)
15 minutes of daily wear
• Lens B (comfilcon A)
15 minutes of daily wear

Locations

Country	Name	City	State
United Kingdom	The University of Manchester	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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