A Clinical Performance of Two Soft Toric Contact Lenses

Study Overview
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Brief Summary
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The study objective was to gather short-term clinical performance data for two soft toric contact lenses.

Detailed Description
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This participant-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses. Participants attended one study visit which lasted for approximately 1.5 hours.

Official Title
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A Clinical Performance of Two Soft Toric Contact Lenses

Conditions
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Astigmatism

Intervention / Treatment
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* Device: Lens 1 (omafilcon B)
* Device: Lens 2 (fanfilcon A)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: They are of legal age (18) and capacity to volunteer. 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 currently wear soft contact lenses, or have done so within the past two years. They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC. They are expected to be able to be fitted with the study lenses within the power range available. 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 an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Ages Eligible for Study
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Minimum Age: 18 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: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants received Lens 1 and then Lens 2 in fixed-sequence order.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lens 1<br>All participants wore Lens 1 for 15 minutes (Period 1) | Device: Lens 1 (omafilcon B)<br>* Toric daily wear contact lens for 15 minutes<br>|
| Experimental: Lens 2<br>All participants wore Lens 2 for 15 minutes (Period 2) | Device: Lens 2 (fanfilcon A)<br>* Toric daily wear contact lens for 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Overall Score | The subjective overall impression of the contact lens (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Extremely poor, 100=Excellent. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Comfort | Subjective comfort (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Causes pain,100=Excellent. | 15 minutes | 
| Subjective Vision | Subjective vision (scored as a single value per participant) was assessed using a 0-100 visual analogue scale where 0=Unacceptable,100=Excellent. | 15 minutes |