Evaluation of Safety and Tolerability of Ocular Lubricants
Status
Completed
Conditions
Dry Eye
Treatments
Other: NGF6-E test formulation
Other: NGF5-A test formulation
Other: NGF6-B test formulation
Other: NGF4-B test formulation
Other: Systane eye drop
Details and patient eligibility
About
The purpose of this study is to evaluate the safety profile of test formulations for an artificial tear product versus a comparator product.
Full 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.
Enrollment
41 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
41 participants in 5 patient groups
Sequence 1
Other group
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
Treatment:
Other: NGF6-B test formulation
Other: NGF6-E test formulation
Other: NGF4-B test formulation
Other: NGF5-A test formulation
Other: Systane eye drop
Sequence 2
Other group
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
Treatment:
Other: NGF6-B test formulation
Other: NGF6-E test formulation
Other: NGF4-B test formulation
Other: NGF5-A test formulation
Other: Systane eye drop
Sequence 3
Other group
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
Treatment:
Other: NGF6-B test formulation
Other: NGF6-E test formulation
Other: NGF4-B test formulation
Other: NGF5-A test formulation
Other: Systane eye drop
Sequence 4
Other group
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
Treatment:
Other: NGF6-B test formulation
Other: NGF6-E test formulation
Other: NGF4-B test formulation
Other: NGF5-A test formulation
Other: Systane eye drop
Sequence 5
Other group
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
Treatment:
Other: NGF6-B test formulation
Other: NGF6-E test formulation
Other: NGF4-B test formulation
Other: NGF5-A test formulation
Other: Systane eye drop
Trial contacts and locations
2
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Data sourced from clinicaltrials.gov
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