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

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

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

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Soft Toric Custom Made Contact lens
* Device: Soft Spherical Contact Lenses
* Device: Spectacle Correction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Subjects will only be eligible for the study if: They are of legal age between 18 and 40 years. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They are current wearers of any soft contact lens (i.e. have worn lenses in the last six months). They have refractive ocular astigmatism between 0.00DC and -1.50DC in one or both eyes. They have a spherical component to their ocular refractive error between 0.00 and - 6.00 DS. 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. They can be fitted satisfactorily with both lens types. They own an acceptable pair of spectacles. 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: They have an ocular disorder which would normally contra-indicate contact lens wear. They have a systemic disorder which would normally contra-indicate contact lens wear. They are using any topical medication such as eye drops or ointment. They have had corneal refractive surgery. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. They are pregnant or breastfeeding. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. They have an amblyopic eye, in which case only dominant eye will be assessed for that subject. They have an infectious disease (e.g. hepatitis), any immunosuppressive disease (e.g. HIV) or diabetes. They have a history of severe allergic reaction or anaphylaxis. They have taken part in any other contact lens clinical trial or research, within two weeks prior to starting this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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) |