A Study to Assess Efficacy and Safety 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.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

637 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-10

Study Completion Date

2019-11-22

Brief Summary

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

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Detailed Description

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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

TRIPLE

Participants Caregivers Investigators

Study Groups

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0.25% HL036 Ophthalmic Solution

Participants self-administered HL036 0.25% 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

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

Intervention Type BIOLOGICAL

Placebo vehicle solution

Interventions

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HL036 Ophthalmic Solution

Intervention Type BIOLOGICAL

Placebo

Placebo vehicle solution

Intervention Type BIOLOGICAL

Other Intervention Names

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Tanfanercept

Eligibility Criteria

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Inclusion Criteria

* Have a patient-reported history of dry eye for at least 6 months prior to Visit 1
* Be willing and able to comply with all study procedures
* Have 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 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 any previous experience using HL036

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No