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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06438601
Other study ID # EX-MKTG-159
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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