Evaluation of Safety and Tolerability of Ocular Lubricants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.

Detailed Description
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Subjects will be randomized to one of five different treatment sequences. Subjects will attend 6 scheduled visits with an expected individual duration of participation of 11 to 42 days. This study will be conducted in Australia.

Official Title
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Evaluation of Safety and Tolerability of Ocular Lubricants

Conditions
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Dry Eye

Intervention / Treatment
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* Other: NGF5-A test formulation
* Other: NGF4-B test formulation
* Other: NGF6-B test formulation
* Other: NGF6-E test formulation
* Other: Systane eye drop


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Able to understand and sign an informed consent form. Willing and able to attend all study visits as required by the protocol. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Any known active ocular disease. Any systemic condition that, in the opinion of the investigator, may affect a study outcome variable. Any ocular injury to either eye in the past 12 weeks prior to screening. 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: Sequence 1<br>NGF5-A/NGF4-B/NGF6-B/NGF6-E/Systane, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation | Other: NGF5-A test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF4-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-E test formulation<br>* One drop of investigational product instilled on the eye<br>Other: Systane eye drop<br>* One drop of commercial product instilled on the eye<br>|
| Other: Sequence 2<br>NGF4-B/NGF6-B/NGF6-E/Systane/NGF5-A, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation | Other: NGF5-A test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF4-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-E test formulation<br>* One drop of investigational product instilled on the eye<br>Other: Systane eye drop<br>* One drop of commercial product instilled on the eye<br>|
| Other: Sequence 3<br>NGF6-B/NGF6-E/Systane/NGF5-A/NGF4-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation | Other: NGF5-A test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF4-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-E test formulation<br>* One drop of investigational product instilled on the eye<br>Other: Systane eye drop<br>* One drop of commercial product instilled on the eye<br>|
| Other: Sequence 4<br>NGF6-E/Systane/NGF5-A/NGF4-B/NGF6-B, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation | Other: NGF5-A test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF4-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-E test formulation<br>* One drop of investigational product instilled on the eye<br>Other: Systane eye drop<br>* One drop of commercial product instilled on the eye<br>|
| Other: Sequence 5<br>Systane/NGF5-A/NGF4-B/NGF6-B/NGF6-E, 1 drop instilled to each eye, with a wash-out period of 1 to 7 days between each instillation | Other: NGF5-A test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF4-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-B test formulation<br>* One drop of investigational product instilled on the eye<br>Other: NGF6-E test formulation<br>* One drop of investigational product instilled on the eye<br>Other: Systane eye drop<br>* One drop of commercial product instilled on the eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment-Emergent Adverse Events (AEs) | An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the investigational medical device (test product). The number of adverse events as observed or reported will be recorded. | Up to Day 30 (Study Exit) | 
| Number of Subjects with Biomicroscopy Findings Outside of Normal Limits | The cornea, conjunctiva, and eyelid will be assessed using a slit lamp. The number of subjects with biomicroscopy findings outside of normal limits will be recorded. | Screening, up to Day 30 (Study Exit) | 
| Mean Total Ocular Surface Staining Score | Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale. | Screening, up to Day 30 (Study Exit) | 
| Mean Best Corrected Visual Acuity (BCVA) | Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR). | Screening, up to Day 30 (Study Exit) | 
| Number of Device Deficiencies | A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. The number of device deficiencies as observed or reported will be recorded. | Up to Day 30 (Study Exit) |