CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
0.1% AG-86893 Eye Drops +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03533244
NCT03533244Phase 2Completed

A Multicenter, Prospective, Randomized, Double-Masked, Phase 2 Study Evaluating the Safety, Tolerability, and Efficacy of Topical AG-86893 in Patients With Pterygium

Allgenesis Biotherapeutics Inc.·interventional·Posted May 23, 2018·Updated Nov 6, 2020

In Brief

A Phase 2 clinical trial evaluating 0.1% AG-86893 Eye Drops, 0.3% AG-86893 Eye Drops, and 1 other intervention for Pterygium. Completed, enrolled 64 participants across 6 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPterygium
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 23, 2018
Enrollment StartOct 11, 2018
Primary CompletionSep 5, 2019
Study CompletionOct 25, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.1 years ago

Interventions

0.1% AG-86893 Eye Dropsdrug

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

0.3% AG-86893 Eye Dropsdrug

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

Vehicle Eye Dropsdrug

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