A Phase 3 interventional study of tanfanercept and Vehicle in Dry Eye, sponsored by HanAll BioPharma Co., Ltd.. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by HanAll BioPharma Co., Ltd. · Phase 3, Interventional, and Treatment
The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.
The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's planned enrollment of 750 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →HanAll BioPharma Co., Ltd. is the lead sponsor of 16 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
0.25% tanfanercept ou bid for 12 weeks
Drug: tanfanercept
1.0% tanfanercept ou bid for 12 weeks
Drug: tanfanercept
Vehicle ou bid for 12 weeks
Drug: Vehicle
TNF inhibitor
Same composition as tanfanercept but without the active ingredient
Schirmer Test
The proportion of participants with improvement from baseline in unanesthetized Schirmer
Time frame: 12 weeks
Schirmer Test
Change from baseline in unanesthetized Schirmer test score
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Symptom Assessment in Dry Eye
Change from baseline in Symptom Assessment in Dry Eye
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
VAS
Change from baseline in Eye dryness, burning/stinging, itching, foreign body sensation, eye discomfort, photophobia, and pain on the visual analog scale (VAS)
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Conjunctival redness
Change from baseline in conjunctival redness on BHVI bulbar redness scale
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Corneal staining
Change from baseline in corneal staining on NEI scale
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks
Comfort Score (Exploratory)
Study product instillation score at each post-baseline visit
Time frame: 2 weeks, 4 weeks, 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is suspended, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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HanAll BioPharma Co., Ltd.