A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/21/2017
Start Date:May 15, 2017
End Date:July 6, 2017

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A Single-Center, Phase 2a, Randomized, Double Masked, Clinical Study to Assess the Safety, Tolerability, and Pharmacodynamic Activity of ADX-102 Ophthalmic Solution in Subjects With Dry Eye Syndrome

The objective of this study is to evaluate the safety, tolerability, and pharmacodynamic
activity of ADX-102 Ophthalmic Solutions and ADX-102 Ophthalmic Lipid Solution in subjects
with dry eye syndrome.


Inclusion Criteria:

- Be at least 18 years of age of either gender and any race;

- Have a reported history of dry eye for at least 6 months prior to Visit 1;

- Have a history of use or desire to use eye drops for dry eye symptoms within 6 months
of Visit 1;

Exclusion Criteria:

- Have any clinically significant slit lamp findings at Visit 1 that may include active
blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active
ocular allergies that require therapeutic treatment, and/or in the opinion of the
investigator may interfere with study parameters;

- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
ocular inflammation at Visit 1;

- Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses
during the study;

- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the
last 12 months;

- Have used cyclosporine 0.05% or lifitigrast 5.0% ophthalmic solution within 45 days of
Visit 1;

- Have any planned ocular and/or lid surgeries over the study period or any ocular
surgery within the last 6 months;

- Be using or anticipate using temporary punctal plugs during the study that have not
been stable within 30 days of Visit 1;
We found this trial at
1
site
Andover, Massachusetts 01810
?
mi
from
Andover, MA
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