A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye
Completed · Phase 3 · Has a placebo group
Conditions studied: Dry Eye
In brief
The objective of this study was to compare the safety and efficacy of tanfanercept ophthalmic solution 0.25% with placebo for the treatment of the signs and symptoms of dry eye.
Key facts
- Study ID
- NCT05109702
- Run by
- HanAll BioPharma Co., Ltd.
- People needed
- 260
- Starts
- 2021-11-18
- Expected to finish
- 2022-05-06
- Last updated by the study team
- 2023-10-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Have a participant-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
- Have a best-corrected visual acuity (BCVA) of 0.7 minimum angle of resolution (logMAR) or better (Snellen equivalent score of 20/100 or better) in each eye at Visit 1
- Report a score of ≥ 2 according to the Ora Calibra® ocular discomfort \& 4-symptom questionnaire in at least one of the dry eye symptoms at Visits 1 and 2
- Have a Schirmer's Test score of ≤ 10 millimeter (mm) and ≥ 1 mm in at least one eye at Visits 1 and 2
- Have a corneal fluorescein staining score ≥ 2 according to the Ora Calibra® corneal and conjunctival staining scale for grading of fluorescein staining in at least 1 of the corneal regions (inferior, superior, or central) in at least 1 eye at Visits 1 and 2
- Have a conjunctival redness score ≥ 1 according to the Ora Calibra® conjunctival redness for dry eye scale in at least 1 eye at Visits 1 and 2
You may not qualify if…
- Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, 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 any cyclosporine-containing drops (such as Restasis®, Cequa®), or lifitegrast ophthalmic solution (Xiidra®) within 60 days of Visit 1
- Have any previous experience using TNF inhibitor ophthalmic solutions, such Tanfanercept Ophthalmic Solution
- Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial (excluding medications allowed for the conduct of the study)
- Be a woman who is pregnant, nursing or planning a pregnancy
Where it is running
- Cornea & Cataract Consultants of Arizona — Phoenix, Arizona, United States
- Global Research Management — Glendale, California, United States
- Eye Research Foundation, Inc. — Newport Beach, California, United States
- The Eye Care Institute - Butchertown Clinical Trials — Louisville, Kentucky, United States
- Andover Eye Associates: Raynham — Raynham, Massachusetts, United States
- Center For Sight — Henderson, Nevada, United States
- Oculus Research, Inc. — Garner, North Carolina, United States
- Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
- Andover Eye Associates: Warwick — Warwick, Rhode Island, United States
- Advancing Vision Research, LLC. — Smyrna, Tennessee, United States
Full record on ClinicalTrials.gov
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