A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

Nicox Ophthalmics, Inc.516 enrolled

Overview

This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

516

Conditions

Healthy Subjects

Interventions

AC-170 0.24%DRUG

AC-170 VehicleDRUG

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * at least 2 years of age * be able to self-administer eye drops or have a parent/legal guardian available for this purpose * if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis) * have ocular health within normal limits Exclusion Criteria: * known contraindications or sensitivities to the study medication or its components * any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters * use of disallowed medication during the period indicated prior to the enrollment or during the study * be pregnant, nursing, or planning a pregnancy

Locations (1)

Ora Clinical Site Network

Andover, Massachusetts, United States

Outcomes

Primary Outcomes

Tolerability of AC 170 0.24% at Visit 1 (Day 1)

Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Tolerability of AC 170 0.24% at Visit 2 (Day 8)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Tolerability of AC 170 0.24% at Visit 3 (Day 22)

Time frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Number of Treatment Related Adverse Events

Adverse events will be measured through study completion

Time frame: up to 12 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.