Phase 2
Completed N=100
A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye
Source: ClinicalTrials.gov NCT04092907 ↗Enrolled (actual)
100
Serious AEs
—
Results posted
Aug 2021
Primary outcomePrimary: Inferior Corneal Staining (ICS) Score — 1.8; 1.9 units on a scale
Summary
The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inferior Corneal Staining (ICS) Score |
1.8; 1.9 | — |
| SECONDARY Ocular Discomfort Score |
2.94; 3.10 | — |
Eligibility Criteria
Inclusion Criteria
- Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops;
- Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
- Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator;
- Must be willing to complete all study assessments required by the protocol.
Exclusion Criteria
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
- Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months, or had femtosecond small incision lenticule extraction (SMILE) within the last 12 months, or had phacoemulsification within the last 3 months, or had dry eye or aggravation of dry eye caused by other ocular operations has not been stable;
- Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;
Data sourced from ClinicalTrials.gov (NCT04092907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.