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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: Test Contact lens; Device: Control Contact lens

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • Eurolens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Contact lens; Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.	Device: Test Contact lens; Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.; Other Names: Soft comfilcon A toric contact lenses; Device: Control Contact lens; Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.; Other Names: Soft comfilcon A sphere contact lenses
Active Comparator: Control Contact lens; Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.	Device: Test Contact lens; Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.; Other Names: Soft comfilcon A toric contact lenses; Device: Control Contact lens; Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.; Other Names: Soft comfilcon A sphere contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Lens Fit	Lens fit was assessed as either 'acceptable' or 'not acceptable' for standard fit by study investigator.	30 minutes

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Philip Morgan, PhD., University of Manchester

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): June 7, 2021

Study Registration Dates

• First Submitted: August 14, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): November 22, 2021
• Last Update Submitted That Met QC Criteria: November 19, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: C19-679 (EX-MKTG-115)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes