Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Other: Systane Ultra Lubricant Eye Drops
* Other: Hialid 0.1 Artificial Tears Eye Drops
* Other: Unisol 4 Saline Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with mild to moderate dry eye as defined in the protocol. Able and willing to follow instructions. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any medical condition that may affect the results of the study. History or evidence of ocular or intraocular surgery within the past six months. History of intolerance or hypersensitivity to any component of the study medications. Use of concomitant topical ocular medications during the study period. Ocular conditions that may preclude safe administration of the test article. Unwilling to discontinue contact lens wear during the study period. Participation in an investigational drug or device study within 30 days of enrollment. Other protocol-defined 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Systane, Hialid, Unisol<br>1 drop Systane in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit. | Other: Systane Ultra Lubricant Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Hialid 0.1 Artificial Tears Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Unisol 4 Saline Solution<br>* One drop in study eye, one time, during office visit.<br>|
| Other: Systane, Unisol, Hialid<br>1 drop Systane in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit. | Other: Systane Ultra Lubricant Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Hialid 0.1 Artificial Tears Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Unisol 4 Saline Solution<br>* One drop in study eye, one time, during office visit.<br>|
| Other: Hialid, Systane, Unisol<br>1 drop Hialid in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Unisol in study eye at Visit 4, with a minimum of 24 hours between each visit. | Other: Systane Ultra Lubricant Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Hialid 0.1 Artificial Tears Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Unisol 4 Saline Solution<br>* One drop in study eye, one time, during office visit.<br>|
| Other: Hialid, Unisol, Systane<br>1 drop Hialid in study eye at Visit 2, 1 drop Unisol in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit. | Other: Systane Ultra Lubricant Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Hialid 0.1 Artificial Tears Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Unisol 4 Saline Solution<br>* One drop in study eye, one time, during office visit.<br>|
| Other: Unisol, Systane, Hialid<br>1 drop Unisol in study eye at Visit 2, 1 drop Systane in study eye at Visit 3, 1 drop Hialid in study eye at Visit 4, with a minimum of 24 hours between each visit. | Other: Systane Ultra Lubricant Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Hialid 0.1 Artificial Tears Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Unisol 4 Saline Solution<br>* One drop in study eye, one time, during office visit.<br>|
| Other: Unisol, Hialid, Systane<br>1 drop Unisol in study eye at Visit 2, 1 drop Hialid in study eye at Visit 3, 1 drop Systane in study eye at Visit 4, with a minimum of 24 hours between each visit. | Other: Systane Ultra Lubricant Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Hialid 0.1 Artificial Tears Eye Drops<br>* One drop in study eye, one time, during office visit.<br>Other: Unisol 4 Saline Solution<br>* One drop in study eye, one time, during office visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular surface residence time | Ocular surface residence time is defined as the time for fluorescence intensity to return to baseline value after a drop of ophthalmic dye is instilled in the study eye. Dye retention will be measured with a fluorophotometer. | Time to event | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye, Ocular Retention Time