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NCT05372107 | Completed | Dry Eye Disease

A Study of AG-80308 in Dry Eye Patients
Sponsor:

Allgenesis Biotherapeutics Inc.

Brief Summary:

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

Condition or disease

Dry Eye Disease

Intervention/treatment

AG-80308

Phase

Phase 1

Study Type : Interventional
Estimated Enrollment : 84 participants
Masking : Quadruple
Primary Purpose : Treatment
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
Actual Study Start Date : June 13, 2022
Estimated Primary Completion Date : November 2, 2022
Estimated Study Completion Date : November 2, 2022
Arm Intervention/treatment

Experimental: Group 1

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

Other: AG-80308

Experimental: Group 2

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

Other: AG-80308

Experimental: Group 3

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

Other: AG-80308

Experimental: Group 4

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

Other: AG-80308
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
A Study of AG-80308 in Dry Eye Patients

Location Details

Please Choose a site

A Study of AG-80308 in Dry Eye Patients

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Eye Research Foundation

Newport Beach, California, United States, 92663

Not yet recruiting

United States, Massachusetts

Andover Eye Associates

Raynham, Massachusetts, United States, 02767

Not yet recruiting

United States, Utah

Alpine Research Organization, Inc.

Clinton, Utah, United States, 84015