Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses

Myopia Clinical Trial

Official title:

Vision Stability and Preference for Soft Toric vs. Soft Spherical Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536571
• Other study ID #: C19-679 (EX-MKTG-115)
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Astigmatism
• Myopia

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