A Study of AG-80308 in Dry Eye Patients

NCT05372107 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: P1-80308-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Evaluation of adverse events (AEs) and serious AEs (SAEs)

  Screening to 3 months

Other Outcomes (3)

• Mean change from baseline in ocular surface staining

  Screening to 3 months

• Mean change from baseline in dry eye symptoms

  Screening to 3 months

• Mean change from baseline in Schirmer's test

  Screening to 3 months

Study Arms (4)

Group 1

EXPERIMENTAL

One drop of 0.001% AG-80308, two times daily to both eyes for 3 months

Drug: AG-80308

Group 2

EXPERIMENTAL

One drop of 0.03% AG-80308, two times daily to both eyes for 3 months

Drug: AG-80308

Group 3

EXPERIMENTAL

One drop of 0.1% AG-80308, two times daily to both eyes for 3 months

Drug: AG-80308

Group 4

EXPERIMENTAL

One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months

Drug: AG-80308

Interventions

AG-80308 DRUG

AG-80308 Eye Drop Solution

Also known as: AGN-232411

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older at the screening visit
• Diagnosis of dry eye disease in both eyes with or without meibomian gland disease

You may not qualify if:

• 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)
• Any ocular infection or inflammation within 30 days prior to the screening visit
• Corneal disorder or abnormalities other than dry eye disease that impact normal spreading of the tear film (except superficial punctate keratitis)
• 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.
• Use of contact lenses in either eye within 14 days of screening visit or planned use during the study
• Use of the dry eye and/or meibomian gland disease medications/procedures within 2 to 8 weeks prior to the screening visit

Sponsors & Collaborators

• Allgenesis Biotherapeutics Inc.: lead
• ORA, Inc.: collaborator

Study Sites (3)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Alpine Research Organization, Inc.

Clinton, Utah, 84015, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2022
• First Posted: May 12, 2022
• Study Start: June 13, 2022
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)