A Study to Assess Efficacy of HL036 in Subjects With Dry Eyes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-05

Study Completion Date

2018-04-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this study was to compare the safety and efficacy of 0.10% and 0.25% HL036 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes

NCT03846453

Dry Eye

COMPLETED PHASE3

A Study Evaluating HBM9036 Efficacy and Safety on Moderate to Severe Dry Eye

NCT04633213

Dry Eye

UNKNOWN PHASE3

A Study to Assess the Efficacy and Safety of Tanfanercept (HL036) Ophthalmic Solution in Participants With Dry Eye

NCT05109702

Dry Eye

COMPLETED PHASE3

Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye

NCT01240382

Dry Eye

COMPLETED PHASE3

Phase 1 Study for Safety and Tolerability of HL036

NCT02717208

Dry Eye

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.10% HL036 Ophthalmic Solution

Participants self-administered HL036 0.10 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57.

Group Type EXPERIMENTAL

HL036 ophthalmic solution

Intervention Type BIOLOGICAL

HL036 ophthalmic solution

0.25% HL036 Ophthalmic Solution

Participants self-administered HL036 0.25% ophthalmic solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.

Group Type EXPERIMENTAL

HL036 ophthalmic solution

Intervention Type BIOLOGICAL

HL036 ophthalmic solution

Placebo

Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57.

Group Type PLACEBO_COMPARATOR

Placebo vehicle solution

Intervention Type OTHER

Placebo vehicle solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HL036 ophthalmic solution

Intervention Type BIOLOGICAL

Placebo vehicle solution

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tanfanercept

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Have a patient-reported history of dry eye for at least 6 months prior to enrollment
* Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
* Have in the study eye a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

Exclusion Criteria

* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1
* Have used Restasis® or Xiidra® within 60 days of Visit 1
* 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)
* Have an uncontrolled systemic disease
* Be a woman who is pregnant, nursing or planning a pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No