Evaluation of Comfort in Subjects With Moderate Dry Eye Disease
Status
Completed
Conditions
Dry Eye
Treatments
Other: Systane Hydration
Other: FID123238
Details and patient eligibility
About
The purpose of this study is to evaluate the comfort of an ocular lubricant in dry eye subjects. This study will be conducted in Canada and Australia.
Enrollment
40 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Able to understand and sign an information consent letter
- Willing and able to follow instructions and maintain the appointment schedule
- Has dry eye symptoms
Key Exclusion Criteria:
- Has suffered any ocular injury to either eye in the past 12 weeks
- Is pregnant or lactating at the time of enrollment
Other protocol-specified inclusion/exclusion criteria may apply.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
None (Open label)
40 participants in 5 patient groups
Sequence 1
Experimental group
Description:
FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Treatment:
Other: Systane Hydration
Other: FID123238
Sequence 2
Experimental group
Description:
FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Treatment:
Other: Systane Hydration
Other: FID123238
Sequence 3
Experimental group
Description:
FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Treatment:
Other: Systane Hydration
Other: FID123238
Sequence 4
Experimental group
Description:
FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Treatment:
Other: Systane Hydration
Other: FID123238
Sequence 5
Experimental group
Description:
FID123238 in 4 specification levels (minimum, moderate, moderate plus, maximum) and Systane hydration applied to the ocular surface in 1 of 5 randomized sequences. 1 application per product.
Treatment:
Other: Systane Hydration
Other: FID123238
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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