A Phase 2/3 interventional study of TOP1630 0.1% Ophthalmic Solution TID OU and Placebo to TOP1630 0.1% Ophthalmic Solution TID OU in Dry Eye Syndrome, sponsored by Topivert Pharma Ltd. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by Topivert Pharma Ltd · Phase 2/3, Interventional, and Treatment
In subjects with Dry Eye Syndrome (DES):
The primary objective of this study is to confirm the efficacy of TOP1630 0.1% Ophthalmic Solution TID OU compared to placebo treatment at Day 29 on pre-specified sign and symptom endpoints in subjects with moderate to severe DES.
This study is designed to assess the efficacy and safety of TOP1630 ophthalmic solution in subjects with Dry Eye Syndrome (DES).
Eligible subjects will be randomized double masked to either TOP1630 or placebo for a duration of 28 days' treatment.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 202 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Topivert Pharma Ltd is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Symptoms of dry eye syndrome including:
Signs of dry eye syndrome including:
Exclusion Criteria:
Drug: TOP1630 0.1% Ophthalmic Solution TID OU
Drug: Placebo to TOP1630 0.1% Ophthalmic Solution TID OU
Bilateral ocular drug administration
Bilateral ocular drug administration
Ocular grittiness 6-point (0-5) scale
Ocular grittiness severity assessment
Time frame: Day 29
Ocular surface (all-regions) lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Total region score: inferior, superior, central, temporal, and nasal.
Time frame: Day 29
Ocular discomfort 5-point (0-4) scale
Ocular discomfort severity assessment
Time frame: Day 29
Ocular dryness 6-point (0-5) scale
Ocular dryness severity assessment
Time frame: Day 29
Conjunctival lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Conjunctival sum score: temporal and nasal.
Time frame: Day 29
Corneal lissamine green staining score 5-point (0-4) scale each region
Dry Eye Syndrome ocular staining assessment. Corneal sum score: inferior, superior and central.
Time frame: Day 29
Worst ocular symptom 6-point (0-5) scale
Most severe baseline symptom from reported daily symptoms
Time frame: Day 29
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Topivert Pharma Ltd