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A Study of AG-80308 in Dry Eye Patients

Sponsor
Allgenesis Biotherapeutics Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05372107
Collaborator
ORA, Inc. (Industry)
80
Enrollment
3
Locations
4
Arms
3.9
Anticipated Duration (Months)
26.7
Patients Per Site
6.9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 :
Jun 13, 2022
Anticipated Primary Completion Date :
Oct 9, 2022
Anticipated Study Completion Date :
Oct 9, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of adverse events (AEs) and serious AEs (SAEs) [Screening to 3 months]

    Other Outcome Measures

    1. Mean change from baseline in ocular surface staining [Screening to 3 months]

    2. Mean change from baseline in dry eye symptoms [Screening to 3 months]

    3. Mean change from baseline in Schirmer's test [Screening to 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye Research Foundation Newport Beach California United States 92663
    2 Andover Eye Associates Raynham Massachusetts United States 02767
    3 Alpine Research Organization, Inc. Clinton Utah United States 84015

    Sponsors and Collaborators

    • Allgenesis Biotherapeutics Inc.
    • ORA, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allgenesis Biotherapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT05372107
    Other Study ID Numbers:
    • P1-80308-001
    First Posted:
    May 12, 2022
    Last Update Posted:
    Jul 15, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Eye Diseases

    Study Results

    No Results Posted as of Jul 15, 2022