AG-80308 for Keratoconjunctivitis Sicca

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Alpine Research Organization, Inc., Clinton, UT
Keratoconjunctivitis Sicca+3 More
AG-80308 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.

Eligible Conditions

  • Keratoconjunctivitis Sicca
  • Dry Eye Syndromes

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Screening to 3 months

Screening to 3 months
Evaluation of adverse events (AEs) and serious AEs (SAEs)
Mean change from baseline in Schirmer's test
Mean change from baseline in dry eye symptoms
Mean change from baseline in ocular surface staining

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Group 3
1 of 4
Group 1
1 of 4
Group 4
1 of 4
Group 2
1 of 4
Experimental Treatment

80 Total Participants · 4 Treatment Groups

Primary Treatment: AG-80308 · No Placebo Group · Phase 1

Group 3
Drug
Experimental Group · 1 Intervention: AG-80308 · Intervention Types: Drug
Group 1
Drug
Experimental Group · 1 Intervention: AG-80308 · Intervention Types: Drug
Group 4
Drug
Experimental Group · 1 Intervention: AG-80308 · Intervention Types: Drug
Group 2
Drug
Experimental Group · 1 Intervention: AG-80308 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening to 3 months
Closest Location: Alpine Research Organization, Inc. · Clinton, UT
Photo of utah 1Photo of utah 2Photo of utah 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Keratoconjunctivitis Sicca
0 CompletedClinical Trials

Who is running the clinical trial?

ORA, Inc.Industry Sponsor
56 Previous Clinical Trials
6,526 Total Patients Enrolled
17 Trials studying Keratoconjunctivitis Sicca
2,561 Patients Enrolled for Keratoconjunctivitis Sicca
Allgenesis Biotherapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
89 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female or male, 18 years of age or older at the screening visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.