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AG-80308 for Dry Eye Syndrome

Phase 1
Waitlist Available
Research Sponsored by Allgenesis Biotherapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening to 3 months
Awards & highlights

Study Summary

This trial is testing a new eye drop for people with dry eyes. The eye drops will be compared to a dummy drop, to see if they help relieve symptoms.

Eligible Conditions
  • Dry Eye Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of adverse events (AEs) and serious AEs (SAEs)
Other outcome measures
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 Design

4Treatment groups
Experimental Treatment
Group I: Group 4Experimental Treatment1 Intervention
One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months
Group II: Group 3Experimental Treatment1 Intervention
One drop of 0.1% AG-80308, two times daily to both eyes for 3 months
Group III: Group 2Experimental Treatment1 Intervention
One drop of 0.03% AG-80308, two times daily to both eyes for 3 months
Group IV: Group 1Experimental Treatment1 Intervention
One drop of 0.001% AG-80308, two times daily to both eyes for 3 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG-80308
2022
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Allgenesis Biotherapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
89 Total Patients Enrolled
ORA, Inc.Industry Sponsor
69 Previous Clinical Trials
8,868 Total Patients Enrolled
~28 spots leftby Jul 2025
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