Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.

Detailed Description
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Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.

Official Title
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Evaluation of Safety and Tolerability of Investigational Ocular Lubricants

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Other: FID123300 ocular lubricant
* Other: FID123301 ocular lubricant
* Other: FID122505 ocular lubricant


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Sign an Informed Consent; Have dry eye symptoms; Other protocol-specified inclusion criteria may apply. Key Exclusion Criteria: Ocular abnormalities; Active ocular infection or inflammation not associated with dry eye; History of ocular or intraocular surgery; 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FID123300/FID123301/FID122505<br>FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period. | Other: FID123300 ocular lubricant<br>* Investigational ocular lubricant<br>Other: FID123301 ocular lubricant<br>* Investigational ocular lubricant<br>Other: FID122505 ocular lubricant<br>* Comparator ocular lubricant<br>|
| Other: FID123301/FID122505/FID123300<br>FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period. | Other: FID123300 ocular lubricant<br>* Investigational ocular lubricant<br>Other: FID123301 ocular lubricant<br>* Investigational ocular lubricant<br>Other: FID122505 ocular lubricant<br>* Comparator ocular lubricant<br>|
| Other: FID122505/FID123300/FID123301<br>FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period. | Other: FID123300 ocular lubricant<br>* Investigational ocular lubricant<br>Other: FID123301 ocular lubricant<br>* Investigational ocular lubricant<br>Other: FID122505 ocular lubricant<br>* Comparator ocular lubricant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity (BCVA) with manifest refraction, at distance | BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR) | Day 1, each wear period. A wear period is 1 day. |