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

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: Soft Toric Custom Made Contact lens; Device: Soft Spherical Contact Lenses; Device: Spectacle Correction

• Registration Number: NCT04613882
• Lead Sponsor: Coopervision, Inc.

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2020-10-28
• Study First Submitted QC: 2020-10-28
• Study First Posted: 2020-11-03
• Study Start: 2021-09-28
• Status Verified: 2022-05
• Primary Completion: 2022-06-21
• Study Completion: 2022-06-21
• Results First Submitted: 2023-06-20
• Results First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Results First Posted: 2023-10-11
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Soft Spherical Contact Lenses	Spectacle Correction	Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
Soft Toric Custom Made contact lenses	Soft Toric Custom Made Contact lens	Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
Soft Toric Custom Made contact lenses	Spectacle Correction	Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
Spectacle Correction	Soft Spherical Contact Lenses	Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Soft Spherical Contact Lenses	Soft Spherical Contact Lenses	Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
Spectacle Correction	Spectacle Correction	Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
Soft Toric Custom Made contact lenses	Soft Spherical Contact Lenses	Subjects will be randomized to wear Soft Toric custom made contact lenses for 30 minutes in one eye with other eye patched.
Soft Spherical Contact Lenses	Soft Toric Custom Made Contact lens	Subjects will be randomized to wear soft spherical contact lens for 30 minutes in one eye with other eye patched
Spectacle Correction	Soft Toric Custom Made Contact lens	Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.

Primary Outcome Measures

Name	Time	Method
Visual Acuity	After 30 minutes of dispense (High Contrast VA)	Visual acuity was assessed using logMAR for each intervention.

Secondary Outcome Measures

Name	Time	Method
Slit Lamp Biomicroscopy Findings - Corneal Staining	At Exit (After 30 minutes in each of three interventions)	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.
Slit Lamp Biomicroscopy Findings - Corneal Oedema	At Exit (After 30 minutes in each of three interventions)	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.
Slit Lamp Biomicroscopy Findings - Conjunctival Staining	At Exit (After 30 minutes in each of three interventions)	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.
Slit Lamp Biomicroscopy Findings - Conjunctival Redness	At Exit (After 30 minutes in each of three interventions)	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.
Slit Lamp Biomicroscopy Findings - Limbal Redness	At Exit (After 30 minutes in each of three interventions)	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.
Slit Lamp Biomicroscopy Findings - Papillary Conjunctivitis	At Exit (After 30 minutes in each of three interventions)	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.

Trial Locations

Locations (1)

Eurolens Research; 🇬🇧 Manchester, United Kingdom