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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05372107
Other study ID # P1-80308-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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