A Study of AG-80308 in Dry Eye Patients

Allgenesis Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: AG-80308

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372107

P1-80308-001

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 4 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: AG-80308

Group 2

Experimental group

Description:

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

Treatment:

Drug: AG-80308

Group 3

Experimental group

Description:

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

Treatment:

Drug: AG-80308

Group 4

Experimental group

Description:

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

Treatment:

Drug: AG-80308