Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.

Official Title
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Evaluation of Comfort in Subjects With Moderate Dry Eye Disease

Conditions
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Dry Eye

Intervention / Treatment
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* Other: FID123238
* Other: Systane Hydration


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an information consent letter Willing and able to follow instructions and maintain the appointment schedule Has dry eye symptoms Key Exclusion Criteria: Has suffered any ocular injury to either eye in the past 12 weeks Is pregnant or lactating at the time of enrollment Other protocol-specified inclusion/exclusion criteria may apply.

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. | Other: FID123238<br>* Lubricant applied to the ocular surface<br>Other: Systane Hydration<br>* Drops applied to the ocular surface<br>|
| Experimental: Sequence 2<br>FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. | Other: FID123238<br>* Lubricant applied to the ocular surface<br>Other: Systane Hydration<br>* Drops applied to the ocular surface<br>|
| Experimental: Sequence 3<br>FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. | Other: FID123238<br>* Lubricant applied to the ocular surface<br>Other: Systane Hydration<br>* Drops applied to the ocular surface<br>|
| Experimental: Sequence 4<br>FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. | Other: FID123238<br>* Lubricant applied to the ocular surface<br>Other: Systane Hydration<br>* Drops applied to the ocular surface<br>|
| Experimental: Sequence 5<br>FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product. | Other: FID123238<br>* Lubricant applied to the ocular surface<br>Other: Systane Hydration<br>* Drops applied to the ocular surface<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in comfort rating | A visual analogue scale will be used | Baseline, up to 12 Hours (Day 1, each product) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry eye