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

• Sponsor: Coopervision, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04613882
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 6.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Astigmatism	Device: Soft Toric Custom Made Contact lens; Device: Soft Spherical Contact Lenses; Device: Spectacle Correction	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Quantification of the Visual Benefits of Soft Toric Contact Lenses Compared to Soft Spherical Contact Lenses Over a Range of Refractive Astigmatism
• Actual Study Start Date: Sep 28, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [Baseline]

   Visual acuity will be assessed using logMAR

2. Visual Acuity [After 30 minutes of dispense]

   Visual acuity will be assessed using logMAR

Secondary Outcome Measures

1. Slit Lamp Biomicroscopy Findings - Conjunctival Redness [Baseline]

   Slit lamp Biomicroscopy findings will be 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).

2. Slit Lamp Biomicroscopy Findings - Conjunctival Redness [After 30 minutes of dispense]

   Slit lamp Biomicroscopy findings will be 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).

3. Slit Lamp Biomicroscopy Findings - Limbal Redness [Baseline]

   Slit lamp Biomicroscopy findings will be 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).

4. Slit Lamp Biomicroscopy Findings - Limbal Redness [After 30 minutes of dispense]

   Slit lamp Biomicroscopy findings will be 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).

5. Slit Lamp Biomicroscopy Findings - Corneal staining [Baseline]

   Slit lamp Biomicroscopy findings will be 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).

6. Slit Lamp Biomicroscopy Findings - Corneal staining [After 30 minutes of dispense]

   Slit lamp Biomicroscopy findings will be 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).

7. Slit Lamp Biomicroscopy Findings - Conjunctival staining [Baseline]

   Slit lamp Biomicroscopy findings will be 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).

8. Slit Lamp Biomicroscopy Findings - Conjunctival staining [After 30 minutes of dispense]

   Slit lamp Biomicroscopy findings will be 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).

9. Slit Lamp Biomicroscopy Findings - Papillary conjunctivitis [Baseline]

   Slit lamp Biomicroscopy findings will be 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).

10. Slit Lamp Biomicroscopy Findings - Papillary conjunctivitis [After 30 minutes of dispense]

    Slit lamp Biomicroscopy findings will be 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).

11. Slit Lamp Biomicroscopy Findings - Location of Corneal staining [Baseline]

    Slit lamp Biomicroscopy findings will be 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).

12. Slit Lamp Biomicroscopy Findings - Location of Corneal staining [After 30 minutes of dispense]

    Slit lamp Biomicroscopy findings will be 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).

13. Slit Lamp Biomicroscopy Findings - Corneal Oedema [Baseline]

    Slit lamp Biomicroscopy findings will be 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).

14. Slit Lamp Biomicroscopy Findings - Corneal Oedema [After 30 minutes of dispense]

    Slit lamp Biomicroscopy findings will be 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eurolens Research	Manchester		United Kingdom	M13 9PL

Sponsors and Collaborators

• Coopervision, Inc.

Investigators

• Principal Investigator: Michael Read, Eurolens Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Coopervision, Inc.
• ClinicalTrials.gov Identifier: NCT04613882
• Other Study ID Numbers: C19-683 (EX-MKTG-116)
• First Posted: Nov 3, 2020
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• 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
• Additional relevant MeSH terms: Astigmatism

Study Results

No Results Posted as of May 6, 2022