Evaluation of Orientation and Visual Acuity of Four Toric Soft Contact Lenses When Head is Tilted at 90 Degrees

Study Overview
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Brief Summary
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The purpose of this study is to determine the relative performance of a new toric soft contact lens against three toric contact lens currently available in market, specifically with orientation and visual acuity when head is tilted at 90 degrees.

Detailed Description
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Non-dispensing single-masked (subject-masked), randomised, 1-visit controlled study,  2 hour duration.

Official Title
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Clinical and Theoretical Evaluation of Factors Affecting Soft Toric Lens Performance: Part 3

Conditions
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Astigmatism

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: be at least 18 and less than or equal to 50 years of age be able and willing to adhere to the instructions set forth in the protocol. have a distance spherical component between -1.00 D and -6.00D with cylinder in the range of 0.75 D to 1.75D Sign the STATEMENT OF INFORMED CONSENT. Have normal, healthy eyes Exclusion Criteria: The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear. Pre-existing ocular disease precluding contact lens fitting. Insufficient lacrimal secretions Aphakia, keratoconus or a highly irregular cornea Previous eye surgery involving the anterior segment Current pregnancy or lactation (to the best of the subject's knowledge). Use of concurrent ocular medication Active participation in another clinical study at any time during this study.-

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: lotrafilcon B/senofilcon A/balafilcon A/omafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. Period 1: lotrafilcon B /period 2: senofilcon A / period 3: balafilcon A / period 4: omafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 2 lotrafilcon B/omafilcon A/senofilcon A/balafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: omafilcon A / period 3: senofilcon A / period 4: balafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 3 lotrafilcon B/balafilcon A/senofilcon A/omafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: lotrafilcon B / period 2: balafilcon A / period 3: senofilcon A / period 4: omafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 4 senofilcon A/lotrafilcon B/omafilcon A/balafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: balafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 5 senofilcon A/omafilcon A/balafilcon A/lotrafilcon B<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: omafilcon A / period 3: balafilcon A / period 4: lotrafilcon B | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 6 senofilcon A/balafilcon A/lotrafilcon B/omafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: senofilcon A / period 2: balafilcon A / period 3: lotrafilcon B / period 4: omafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 7 omafilcon B/lotrafilcon B/senofilcon A/balafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: omafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: balafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 8 balafilcon A/lotrafilcon B/senofilcon A/omafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: senofilcon A / period 4: omafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 9 balafilcon A/lotrafilcon B/omafilcon A/senofilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: lotrafilcon B / period 3: omafilcon A / period 4: senofilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 10 balafilcon A/senofilcon A/lotrafilcon B/omafilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: lotrafilcon B / period 4: omafilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 11 balafilcon A/senofilcon A/omafilcon A//lotrafilcon B<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: senofilcon A / period 3: omafilcon A / period 4: lotrafilcon B | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|
| Active Comparator: Group 12 balafilcon A/omafilcon A/lotrafilcon B/senofilcon A<br>One intervention was worn during each study period, which consisted of lens insertion, followed by a 15 minute settling period prior to measurement. All four periods were conducted in one day. period 1: balafilcon A / period 2: omafilcon A / period 3: lotrafilcon B / period 4: senofilcon A | Device: senofilcon A<br>* toric contact lens<br>Device: balafilcon A toric<br>* toric contact lens<br>Device: lotrafilcon B toric<br>* toric contact lens<br>Device: omafilcon A<br>* toric contact lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Orientation During Head Tilt. | Degree of lens rotation on the eye with the head tilted. | after fit of each of the four lens insertions | 
| Visual Acuity During Head Tilt | 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. | after each of the four lens insertions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of Lens Rotation in Superior Gaze. | Degree of lens rotation while participant is gazing up. | After each of the four lens insertions | 
| Degree of Lens Rotation in Superior-temporal Gaze. | Degree of lens rotation while participant is gazing up and out(towards the temple). | After each of 4 lens insertions., | 
| Degree of Lens Rotation in Superior-nasal Gaze. | Degree of lens rotation while participant is gazing up and in(towards the nose). | After each of the four lens insertions | 
| Degree of Lens Rotation in Temporal Gaze. | Degree of lens rotation while participant is gazing out(towards the temple). | After each of the four lens insertions | 
| Degree of Lens Rotation in Nasal Gaze. | Degree of lens rotation while participant is gazing in(towards the nose). | After each of the four lens insertions | 
| Degree of Lens Rotation Inferior-temporal Gaze. | Degree of lens rotation while participant is gazing down and out. | After each of the four lens insertions | 
| Degree of Lens Rotation in Inferior-nasal Gaze. | Degree of lens rotation while participant is gazing down and in. | After each of the four lens insertions | 
| Degree of Lens Rotation in Inferior Gaze. | Degree of lens rotation while participant is gazing down. | After each of the four lens insertions | 

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