Evaluation of Safety and Tolerability of Ocular Lubricants
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Sequence 1 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
One drop of investigational product instilled on the eye
Other: NGF4-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-E test formulation
One drop of investigational product instilled on the eye
Other: Systane eye drop
One drop of commercial product instilled on the eye
|
| Other: Sequence 2 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
One drop of investigational product instilled on the eye
Other: NGF4-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-E test formulation
One drop of investigational product instilled on the eye
Other: Systane eye drop
One drop of commercial product instilled on the eye
|
| Other: Sequence 3 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
One drop of investigational product instilled on the eye
Other: NGF4-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-E test formulation
One drop of investigational product instilled on the eye
Other: Systane eye drop
One drop of commercial product instilled on the eye
|
| Other: Sequence 4 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
One drop of investigational product instilled on the eye
Other: NGF4-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-E test formulation
One drop of investigational product instilled on the eye
Other: Systane eye drop
One drop of commercial product instilled on the eye
|
| Other: Sequence 5 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
One drop of investigational product instilled on the eye
Other: NGF4-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-B test formulation
One drop of investigational product instilled on the eye
Other: NGF6-E test formulation
One drop of investigational product instilled on the eye
Other: Systane eye drop
One drop of commercial product instilled on the eye
|
Outcome Measures
Primary Outcome Measures
- Number of Treatment-Emergent Adverse Events (AEs) [Up to Day 30 (Study Exit)]
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.
- Number of Subjects with Biomicroscopy Findings Outside of Normal Limits [Screening, up to Day 30 (Study Exit)]
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.
- Mean Total Ocular Surface Staining Score [Screening, up to Day 30 (Study Exit)]
Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.
- Mean Best Corrected Visual Acuity (BCVA) [Screening, up to Day 30 (Study Exit)]
Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR).
- Number of Device Deficiencies [Up to Day 30 (Study Exit)]
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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alcon Investigator 8169 | Carlton | Victoria | Australia | 3053 |
| 2 | Alcon Investigator 8214 | Waurn Ponds | Victoria | Australia | 3216 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, Dry Eye, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DEE253-E001