Back to resultsEvaluation of Safety and Tolerability of Ocular Lubricants
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
NGF5-A test formulation
NGF4-B test formulation
NGF6-B test formulation
NGF6-E test formulation
Systane eye drop
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility 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.
Sites / Locations
- Alcon Investigator 8169
- Alcon Investigator 8214
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Other
Other
Other
Other
Other
Arm Label
Sequence 1
Sequence 2
Sequence 3
Sequence 4
Sequence 5
Arm Description
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
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
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
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
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
Outcomes
Primary Outcome Measures
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.
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.
Mean Total Ocular Surface Staining Score
Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.
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).
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05573360
Brief Title
Evaluation of Safety and Tolerability of Ocular Lubricants
Official Title
Evaluation of Safety and Tolerability of Ocular Lubricants
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2022 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Other
Arm Description
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
Arm Title
Sequence 2
Arm Type
Other
Arm Description
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
Arm Title
Sequence 3
Arm Type
Other
Arm Description
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
Arm Title
Sequence 4
Arm Type
Other
Arm Description
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
Arm Title
Sequence 5
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
NGF5-A test formulation
Intervention Description
One drop of investigational product instilled on the eye
Intervention Type
Other
Intervention Name(s)
NGF4-B test formulation
Intervention Description
One drop of investigational product instilled on the eye
Intervention Type
Other
Intervention Name(s)
NGF6-B test formulation
Intervention Description
One drop of investigational product instilled on the eye
Intervention Type
Other
Intervention Name(s)
NGF6-E test formulation
Intervention Description
One drop of investigational product instilled on the eye
Intervention Type
Other
Intervention Name(s)
Systane eye drop
Intervention Description
One drop of commercial product instilled on the eye
Primary Outcome Measure Information:
Title
Number of Treatment-Emergent Adverse Events (AEs)
Description
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.
Time Frame
Up to Day 30 (Study Exit)
Title
Number of Subjects with Biomicroscopy Findings Outside of Normal Limits
Description
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.
Time Frame
Screening, up to Day 30 (Study Exit)
Title
Mean Total Ocular Surface Staining Score
Description
Ocular surface staining will be assessed using a slit lamp and recorded on a 15-point scale.
Time Frame
Screening, up to Day 30 (Study Exit)
Title
Mean Best Corrected Visual Acuity (BCVA)
Description
Visual Acuity will be assessed with correction in place using letter charts. BCVA will be measured in logarithm Minimum Angle of Resolution (logMAR).
Time Frame
Screening, up to Day 30 (Study Exit)
Title
Number of Device Deficiencies
Description
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.
Time Frame
Up to Day 30 (Study Exit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Lead, Dry Eye
Organizational Affiliation
Alcon Research, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Investigator 8169
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
Alcon Investigator 8214
City
Waurn Ponds
State/Province
Victoria
ZIP/Postal Code
3216
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Safety and Tolerability of Ocular Lubricants
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