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A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia

NCT03533244 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-11-06

Study results available
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Summary

A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium.

Hypothesis

1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle
2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle

Conditions

  • Pterygium

Interventions

DRUG

0.1% AG-86893 Eye Drops

One drop, three times daily to the study eye for 28 days

DRUG

0.3% AG-86893 Eye Drops

One drop, three times daily to the study eye for 28 days

DRUG

Vehicle Eye Drops

One drop, three times daily to the study eye for 28 days

Sponsors & Collaborators

  • Allgenesis Biotherapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2019-09-05
Completion
2019-10-25
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533244 on ClinicalTrials.gov