A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution

Anesthesia, Local Clinical Trial

Official title:

A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05501860
• Other study ID #: AG-920-CS303
• Status: Completed
• Phase: Phase 3
• Start date: July 30, 2022
• Est. completion date: December 7, 2022

Study information

• Verified date: January 2023
• Source: American Genomics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 7, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Infertility

Intervention

Drug:
• AG-920
AG-920 Sterile Topical Ophthalmic Solution
• Placebo
Placebo Sterile Topical Ophthalmic Solution

Locations

Country	Name	City	State
United States	American Genomics Site 2	McAllen	Texas
United States	American Genomics Site 1	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
American Genomics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Treatment Emergent Adverse Events (TEAEs)	TEAEs will be summarized by treatment group using frequency and percent for each system, organ, class (SOC) and preferred term within each SOC. Summaries will be presented separately for ocular and non-ocular Adverse Events (AEs).	From randomization through study completion (up to 4 days following treatment); 90 days following treatment for subjects participating in specular microscopy.
Secondary	Mean change from baseline in corneal endothelial cell density after treatment with AG-920	Endothelial cell count (and corneal morphology) will be summarized by continuous summaries	From screening through study completion (90 days following treatment).