A Phase 2 interventional study of A197 Ophthalmic Solution and A197 Vehicle Control in Dry Eye Disease, sponsored by Aramis Biosciences, Inc.. Completed at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by Aramis Biosciences, Inc. · Phase 2, Interventional, and Treatment
The objectives of this trial are to assess the safety, tolerability and efficacy of A197 ophthalmic solution in comparison to a vehicle control in the treatment of subjects with Dry Eye Disease.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 207 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Aramis Biosciences, Inc. as lead sponsor.
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Exclusion Criteria:
Drug: A197 Ophthalmic Solution
Drug: A197 Ophthalmic Solution
Drug: A197 Vehicle Control
Drug: Active Comparator
A197 Ophthalmic Solution
A197 Vehicle Control
Active Comparator
Change from baseline in total corneal fluorescein staining (CFS)
Corneal Fluorescein Staining (tCFS) is graded based on a modified National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 regions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-4 using 0.5 unit increments; 0 corresponds to no staining, 4 corresponds to maximum staining. The total score is the sum of the 5 regions ranging from 0-20.
Time frame: 12 Weeks
Change from baseline in eye dryness via the Visual Analogue Scale (VAS)
Eye dryness is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no symptoms and 100 to severe symptoms.
Time frame: 12 Weeks
Change from baseline in lissamine green conjunctival staining (LGCS)
Lissamine green conjunctival staining (LGCS) is graded based on the NEI Scale. The NEI scale divides the conjunctiva in 6 regions with the score for each region ranging from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 6 regions ranging from 0-18.
Time frame: 12 Weeks
Change from baseline in bulbar conjunctival hyperemia (CCLRU)
Bulbar conjunctival hyperemia is graded based on the Cornea and Contact Lens Research Unit (CCLRU) grading scale where 0 corresponds to none, 4 corresponds to severe.
Time frame: 12 Weeks
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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