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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04536571
Other study ID # C19-679 (EX-MKTG-115)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 3, 2020
Est. completion date June 7, 2021

Study information

Verified date November 2021
Source Coopervision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The principal hypothesis is to be tested in this work is that vision stability (the primary outcome measure) with a spherical contact lens correction vs. a toric contact lens correction will be the same.


Description:

This will be a randomised, subject-masked, crossover, bilateral non-dispensing study, controlled by cross-comparison. Thirty subjects will use each lens type at a single visit in random sequence.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date June 7, 2021
Est. primary completion date June 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: 1. They are aged 18-35 years and have capacity to volunteer. 2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. 3. They are willing and able to follow the protocol. 4. They are an existing wearer of soft spherical contact lenses in both eyes. 5. They have a spherical component of their spectacle refractive error between -0.50DS and -6.50DS in both eyes. 6. They have a cylindrical component of their spectacle refractive error between -0.75DC and -1.25DC in both eyes. 7. They can be fitted satisfactorily with both lens types. 8. They own an acceptable pair of spectacles. 9. They agree not to participate in other clinical research for the duration of the study. Exclusion Criteria: 1. They have an ocular disorder which would normally contra-indicate contact lens wear. 2. They have a systemic disorder which would normally contra-indicate contact lens wear. 3. They are using any topical medication such as eye drops (including comfort drops) or ointment on a regular basis. 4. They are aphakic. 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 are pregnant or breastfeeding. 8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. 10. 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:
Test Contact lens
Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
Control Contact lens
Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.

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 Vision Stability While Doing Tasks on Mobile Phone Vision stability was assessed by study subjects while doing tasks on mobile phone using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) 30 minutes
Primary Vision Stability While Doing Tasks on Desktop Vision stability was assessed by study subjects while doing tasks on desktop using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) 30 minutes
Primary Vision Stability While Walking Vision stability was assessed by study subjects while walking using a 0-100 visual analogue scales (0 - Unacceptable. Lens cannot be worn, 100 - Excellent. Unaware of any visual loss) 30 minutes
Secondary Lens Fit for Test Contact Lens Lens fit was assessed for lens rotation after 10 minutes for toric fit. Lens mislocation from optimal position was measured in 0°, 1-5°, 6-10°, 11-15°, 16-20°, More than 20°. 10 minutes
Secondary Lens Fit Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator. 30 minutes
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