Clinical trial NCT05501860: A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution
Official title: A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, Local
Keywords: AG-920
Articaine
Septocaine
Lead sponsor: American Genomics, LLC
Sponsor class: INDUSTRY
First posted: 2022-08-16
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive a single dose of AG-920 or placebo into one (study) eye (2 drops 30 seconds apart).
Primary purpose: SUPPORTIVE_CARE

Brief summary: A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..

Detailed description: A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations.

Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff.

Eligibility criteria: Inclusion Criteria:

1. Provide written informed consent prior to any study-related procedures being performed.
2. Male or a non-pregnant, non-lactating female.
3. Healthy by clinical assessment, including ocular examination.
4. Have an Early Treatment of Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) of 20/200 or better in both eyes.
5. Have an Intraocular Pressure (IOP) between 7 and 30 mmHg.

   Specular microscopy subset subjects only:
6. Have a central corneal endothelial cell density of ≥1500 cells/mm2 at baseline

Exclusion Criteria:

1. . Have participated in an investigational study within the past 30 days.
2. Have a contraindication to local anesthetics, Septocaine®, or any component of the IMP.
3. Have had ocular surgery or general surgery in either eye within the past 90 days.
4. Have had an intravitreal injection in either eye within 14 days of randomization.
5. Have ocular surface disease requiring punctal plugs.
6. Have evidence of any current ocular inflammation.
7. Current ocular allergy symptoms.
8. Have used topical, ocular medications in the 24 hours preceding dosing.
9. Systemic opioid, opiate analgesic or topical Non-steroidal Anti-Inflammatory Drug (NSAID) use within the past 30 days.
10. Previous participation in a clinical study of AG-920.
11. A current condition which could cause vision problems such as Pseudotumor Cerebri.

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: From Day 1 (treatment day) to 4 days following treatment day; 90 days following treatment for subjects participating in specular microscopy.
Secondary outcomes:
measure: Mean Change From Baseline in Corneal Endothelial Cell Density After Treatment With AG-920
timeFrame: From Day 1 (treatment day) to 90 days following treatment
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: American Genomics Site 1
state: California
city: McAllen
country: United States
facility: American Genomics Site 2
state: Texas
Study officials:
affiliation: Medical Expert
name: Martin Uram, MD
role: STUDY_DIRECTOR
References: