A Study of AG-80308 in Dry Eye Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-13

Study Completion Date

2022-11-02

Brief Summary

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

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Detailed Description

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Conditions

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Dry Eye Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

AG-80308

Intervention Type DRUG

AG-80308 Eye Drop Solution

Group 2

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

Group Type EXPERIMENTAL

AG-80308

Intervention Type DRUG

AG-80308 Eye Drop Solution

Group 3

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

Group Type EXPERIMENTAL

AG-80308

Intervention Type DRUG

AG-80308 Eye Drop Solution

Group 4

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

Group Type EXPERIMENTAL

AG-80308

Intervention Type DRUG

AG-80308 Eye Drop Solution

Interventions

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AG-80308

AG-80308 Eye Drop Solution

Intervention Type DRUG

Other Intervention Names

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AGN-232411

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No