A Study of AG-80308 in Dry Eye Patients

November 28, 2022 updated by: Allgenesis Biotherapeutics Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Eye Research Foundation
    • Massachusetts
      • Raynham, Massachusetts, United States, 02767
        • Andover Eye Associates
    • Utah
      • Clinton, Utah, United States, 84015
        • Alpine Research Organization, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
One drop of 0.001% AG-80308, two times daily to both eyes for 3 months
Drug: AG-80308
AG-80308 Eye Drop Solution
Other Names:
  • AGN-232411
Experimental: Group 2
One drop of 0.03% AG-80308, two times daily to both eyes for 3 months
Drug: AG-80308
AG-80308 Eye Drop Solution
Other Names:
  • AGN-232411
Experimental: Group 3
One drop of 0.1% AG-80308, two times daily to both eyes for 3 months
Drug: AG-80308
AG-80308 Eye Drop Solution
Other Names:
  • AGN-232411
Experimental: Group 4
One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months
Drug: AG-80308
AG-80308 Eye Drop Solution
Other Names:
  • AGN-232411

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of adverse events (AEs) and serious AEs (SAEs)
Time Frame: Screening to 3 months
Screening to 3 months

Other Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in ocular surface staining
Time Frame: Screening to 3 months
Screening to 3 months
Mean change from baseline in dry eye symptoms
Time Frame: Screening to 3 months
Screening to 3 months
Mean change from baseline in Schirmer's test
Time Frame: Screening to 3 months
Screening to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allgenesis Biotherapeutics Inc.

Collaborators

ORA, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2022

Primary Completion (Actual)

November 2, 2022

Study Completion (Actual)

November 2, 2022

Study Registration Dates

First Submitted

May 8, 2022

First Submitted That Met QC Criteria

May 8, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1-80308-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye Disease

Clinical Trials on AG-80308

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe