Back to resultsA Study of AG-80308 in Dry Eye Patients
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AG-80308
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility 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
Sites / Locations
- Eye Research Foundation
- Andover Eye Associates
- Alpine Research Organization, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Group 1
Group 2
Group 3
Group 4
Arm Description
One drop of 0.001% AG-80308, two times daily to both eyes for 3 months
One drop of 0.03% AG-80308, two times daily to both eyes for 3 months
One drop of 0.1% AG-80308, two times daily to both eyes for 3 months
One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months
Outcomes
Primary Outcome Measures
Evaluation of adverse events (AEs) and serious AEs (SAEs)
Secondary Outcome Measures
Full Information
NCT ID
NCT05372107
First Posted
May 8, 2022
Last Updated
November 28, 2022
Sponsor
Allgenesis Biotherapeutics Inc.
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05372107
Brief Title
A Study of AG-80308 in Dry Eye Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
November 2, 2022 (Actual)
Study Completion Date
November 2, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allgenesis Biotherapeutics Inc.
Collaborators
ORA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, double-masked, randomized, parallel-group study with topical AG-80308 eye drops in dry eye patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
One drop of 0.001% AG-80308, two times daily to both eyes for 3 months
Arm Title
Group 2
Arm Type
Experimental
Arm Description
One drop of 0.03% AG-80308, two times daily to both eyes for 3 months
Arm Title
Group 3
Arm Type
Experimental
Arm Description
One drop of 0.1% AG-80308, two times daily to both eyes for 3 months
Arm Title
Group 4
Arm Type
Experimental
Arm Description
One drop of 0.03% AG-80308, new formulation, two times daily to both eyes for 3 months
Intervention Type
Drug
Intervention Name(s)
AG-80308
Other Intervention Name(s)
AGN-232411
Intervention Description
AG-80308 Eye Drop Solution
Primary Outcome Measure Information:
Title
Evaluation of adverse events (AEs) and serious AEs (SAEs)
Time Frame
Screening to 3 months
Other Pre-specified Outcome Measures:
Title
Mean change from baseline in ocular surface staining
Time Frame
Screening to 3 months
Title
Mean change from baseline in dry eye symptoms
Time Frame
Screening to 3 months
Title
Mean change from baseline in Schirmer's test
Time Frame
Screening to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Andover Eye Associates
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Alpine Research Organization, Inc.
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of AG-80308 in Dry Eye Patients
We'll reach out to this number within 24 hrs