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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05633082
Other study ID # EX-MKTG-143
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2022
Est. completion date September 30, 2022

Study information

Verified date November 2022
Source Coopervision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study objective was to gather short-term clinical performance data for two soft toric contact lenses.


Description:

This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - They are of legal age (18) and capacity to volunteer. - They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. - They are willing and able to follow the protocol. - They currently wear soft contact lenses, or have done so within the past two years. - They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC. - They are expected to be able to be fitted with the study lenses within the power range available. Exclusion Criteria: - They have an ocular disorder which would normally contra-indicate contact lens wear. - They have a systemic disorder which would normally contra-indicate contact lens wear. - They are using any topical medication such as eye drops or ointment. - They are aphakic. - They have had corneal refractive surgery. - They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. - They are pregnant or lactating. - They have an eye or health condition including an immunosuppressive or infectious disease 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 contact lens or care system clinical research within two weeks prior to starting this study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Lens 1 (omafilcon B)
Toric daily wear contact lens for 15 minutes
Lens 2 (fanfilcon A)
Toric daily wear contact lens for 15 minutes

Locations

Country Name City State
United Kingdom Eurolens Research 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 Overall Score The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent. 15 minutes
Secondary Subjective Comfort Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent. 15 minutes
Secondary Subjective Vision Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent. 15 minutes
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