Effect of Eye Movement on Toric Lens Orientation and Visual Acuity

Study Overview
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Brief Summary
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The relative performance of a new toric soft contact lens against toric contact lenses currently available in market, specifically for visual acuity and lens orientation. The study will be conducted in a staged approach (2 stages).

Detailed Description
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Non-dispensing, single-masked (subject-masked), randomised, controlled study. Two visits.

Official Title
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Development and Implementation of a Clinical Test to Investigate the Change in Vision With Soft Toric Contact Lenses During Eye Movements

Conditions
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Astigmatism

Intervention / Treatment
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* Device: senofilcon A
* Device: balafilcon A
* Device: omafilcon A
* Device: lotrafilcon B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are aged between 18-39 years. They understand their rights as a research subject and are willing to sign a Statement of Informed Consent. They are willing and able to follow the protocol. They can attain at least 6/9 in each eye with their spectacle refraction. They have successfully worn contact lenses within six months of starting the study. They can be fitted with toric soft contact lenses to match the available power range. Exclusion Criteria: 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 are aphakic. 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 lactating. They have grade 2 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear. They have taken part in any other 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: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 2 LSBO<br>contact lenses worn in this order: lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 3 LOSB<br>contact lenses worn in this order: lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 4 LBSO<br>contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 5 LBOS<br>contact lenses worn in this order: lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 6 SLOB<br>contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, omafilcon A toric, balafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 7 SLBO<br>contact lenses worn in this order: senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 8 SOLB<br>contact lenses worn in this order: senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 9 SBLO<br>contact lenses worn in this order: senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 10 SBOL<br>contact lenses worn in this order: senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 11 OSLB<br>contact lenses worn in this order: omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 12 OSBL<br>contact lenses worn in this order: omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 13 OBLS<br>contact lenses worn in this order: omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 14 OBSL<br>contact lenses worn in this order: omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 15 BLSO<br>contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 16 BLOS<br>contact lenses worn in this order: balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 17 BSOL<br>contact lenses worn in this order: balafilcon A toric, senofilcon A toric, omafilcon A toric, lotrafilcon B toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 18 BOLS<br>contact lenses worn in this order: balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 19 BOSL<br>contact lenses worn in this order: balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|
| Active Comparator: Group 1 LSOB<br>contact lenses worn in this order: lotrafilcon B toric/senofilcon A toric/omafilconA toric/balafilcon A toric | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>Device: lotrafilcon B<br>* toric contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Acuity After Infero-temporal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after insertion | 
| Visual Acuity After Infero-nasal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after lens insertion | 
| Visual Acuity After Superior-temporal Version Movement | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after lens insertion | 
| Visual Acuity After Superior-nasal Version Movement. | logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values > 0.00 indicate vision poorer than the ideal and values <0.00 indicate vision greater than the ideal. | 10 minutes after lens insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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astigmatism, visual acuity, orientation, contact lenses