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Completed

NCT Number: NCT05372107

A Study of AG-80308 in Dry Eye Patients

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

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eye Research Foundation, Newport Beach, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AG-80308

Drug

AG-80308 Eye Drop Solution

Other names: AGN-232411

Primary outcomes

  1. Evaluation of adverse events (AEs) and serious AEs (SAEs)

    Time frame: Screening to 3 months

Other outcomes

  1. Mean change from baseline in ocular surface staining

    Time frame: Screening to 3 months

  2. Mean change from baseline in dry eye symptoms

    Time frame: Screening to 3 months

  3. Mean change from baseline in Schirmer's test

    Time frame: Screening to 3 months

Sponsors and collaborators

Lead sponsor

Allgenesis Biotherapeutics Inc.

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 12, 2022
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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