A Study Evaluating the Efficacy and Safety on Moderate to Severe Dry Eye

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-22

Study Completion Date

2019-07-10

Brief Summary

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The purpose of this study is to compare the efficacy and safety of HBM9036 Ophthalmic Solution versus placebo in the treatment of dry eye

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Detailed Description

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HBM9036 is a molecularly engineered tumor necrosis factor receptor 1 (TNFR1) fragment.

A total of 100 subjects are expected to be randomized. Subjects will be randomized 1:1 at Visit 2 to HBM9036 Ophthalmic Solution or placebo group, bilaterally BID for eight weeks. The primary efficacy endpoint is sign changes from baseline in change from pre- to post-CAE inferior corneal staining score (ICSS) of the study eye evaluated at week 8 .

Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HBM9036 0.25% Ophthalmic Solution

HBM9036, Ophthalmic Solution, twice a day, in the morning and evening

Group Type EXPERIMENTAL

HBM9036 0.25% Ophthalmic Solution

Intervention Type DRUG

Ophthalmic Solution

Placebo Ophthalmic Solution

placebo, Ophthalmic Solution, twice a day, in the morning and evening

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Ophthalmic Solution

Interventions

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HBM9036 0.25% Ophthalmic Solution

Ophthalmic Solution

Intervention Type DRUG

placebo

Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Have a history of use eye drops for dry eye symptoms within 6 months of Visit 1 or desire to use eye drops;
2. Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
3. Be willing and can adjust current treatment for dry eye according to the protocol, judged by the Investigator;
4. Must be willing to complete all study assessments required by the protocol.

Exclusion Criteria

1. Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
2. 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;
3. Have used ophthalmic cyclosporine A, tacrolimus or Xiidra® within 60 days prior to Visit 1;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes