Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses

Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism

The aim of this work is to undertake a range of vision-related measures with soft toric contact lenses soft spherical contact lenses and spectacle lens correction across a range of levels of astigmatism.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Soft Toric Custom Made Contact lens; Device: Soft Spherical Contact Lenses; Device: Spectacle Correction

Detailed Description

This will be a randomised, crossover, partially subject-masked (for contact lenses only), non-dispensing study, controlled by cross-comparison.

• Study Type: Interventional
• Enrollment (Actual): 59
• 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 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

-

Subjects will only be eligible for the study if:

1. They are of legal age between 18 and 40 years.
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 current wearers of any soft contact lens (i.e. have worn lenses in the last six months).
5. They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes.
6. They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS.
7. They could attain at least 0.10 logMAR distance high contrast visual acuity in one eye with the study lenses within the available power range.
8. They can be fitted satisfactorily with both lens types.
9. They own an acceptable pair of spectacles.
10. They agree not to participate in other clinical research for the duration of this study.

Exclusion Criteria:

-

Subjects will not be eligible to take part in the study if:

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 or ointment.
4. They have had corneal refractive surgery.
5. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
6. They are pregnant or breastfeeding.
7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
8. They have an amblyopic eye, in which case only dominant eye will be assessed for that subject.
9. They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes.
10. They have a history of severe allergic reaction or anaphylaxis.
11. They have taken part in any other contact lens 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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soft Toric Custom Made contact lenses; Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.	Device: Soft Toric Custom Made Contact lens; Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.; Device: Soft Spherical Contact Lenses; Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.; Device: Spectacle Correction; Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Active Comparator: Soft Spherical Contact Lenses; Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched	Device: Soft Toric Custom Made Contact lens; Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.; Device: Soft Spherical Contact Lenses; Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.; Device: Spectacle Correction; Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Active Comparator: Spectacle Correction; Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.	Device: Soft Toric Custom Made Contact lens; Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.; Device: Soft Spherical Contact Lenses; Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.; Device: Spectacle Correction; Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity was assessed using logMAR for each intervention.	Baseline with low contrast VA
Visual Acuity	Visual acuity was assessed using logMAR for each intervention.	After 30 minutes of dispense (Low Contrast VA)
Visual Acuity	Visual acuity was assessed using logMAR for each intervention.	Baseline with High contrast VA
Visual Acuity	Visual acuity was assessed using logMAR for each intervention.	After 30 minutes of dispense (High Contrast VA)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Slit Lamp Biomicroscopy Findings - Conjunctival Redness	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.	Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Redness	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.	At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Limbal Redness	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.	Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Limbal Redness	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.	At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Staining	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.	Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Staining	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.	At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.	Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Conjunctival Staining	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.	At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.	Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.	At Exit (After 30 minutes in each of three interventions)
Slit Lamp Biomicroscopy Findings - Corneal Oedema	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments done were recorded prior to the first intervention. Here the time frame used is "Entrance" which refers to the time prior to wear of study lens.	Entrance (Prior to wear of study lens)
Slit Lamp Biomicroscopy Findings - Corneal Oedema	Slit lamp Biomicroscopy findings were assessed on Efron Grading scales scored to the nearest 0.1 on a scale of 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). The assessments were done following the removal of the third intervention. Here the time frame used is "Exit" which refers to those measurements taken post-lens/spectacle wear.	At Exit (After 30 minutes in each of three interventions)

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Michael Read, Eurolens Research

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): June 21, 2022
• Study Completion (Actual): June 21, 2022

Study Registration Dates

• First Submitted: October 28, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): November 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: C19-683 (EX-MKTG-116)

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