A Study of AG-80308 in Dry Eye Patients

Dry Eye Disease Clinical Trial

Official title:

A Multicenter, Double-Masked, Phase 1b Study Evaluating the Safety, Tolerability, and Dose-Response of Topical AG-80308 in Patients With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372107
• Other study ID #: P1-80308-001
• Status: Completed
• Phase: Phase 1
• Start date: June 13, 2022
• Est. completion date: November 2, 2022

Study information

• Verified date: July 2022
• Source: Allgenesis Biotherapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 2, 2022
• Est. primary completion date: November 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female, 18 years of age or older at the screening visit

2. Diagnosis of dry eye disease in both eyes with or without meibomian gland disease

Exclusion Criteria:

1. Participation in any investigational study within 30 days prior to baseline or exposure to an investigational drug must be fully washed out (at least 5 half-lives)

2. Any ocular infection or inflammation within 30 days prior to the screening visit

3. Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis)

4. History of chronic ocular allergy, systemic lupus erythematosus, rheumatoid arthritis, corneal ulcer/erosions, uveitis or dry eye due to Stevens Johnson syndrome, irradiation, alkali burns, cicatricial pemphigoid or vitamin A deficiency.

5. Use of contact lenses in either eye within 14 days of screening visit or planned use during the study

6. Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• AG-80308
AG-80308 Eye Drop Solution

Locations

Country	Name	City	State
United States	Alpine Research Organization, Inc.	Clinton	Utah
United States	Eye Research Foundation	Newport Beach	California
United States	Andover Eye Associates	Raynham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Allgenesis Biotherapeutics Inc.	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean change from baseline in ocular surface staining		Screening to 3 months
Other	Mean change from baseline in dry eye symptoms		Screening to 3 months
Other	Mean change from baseline in Schirmer's test		Screening to 3 months
Primary	Evaluation of adverse events (AEs) and serious AEs (SAEs)		Screening to 3 months