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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756624
• Other study ID #: 15-100-0010
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2016
• Last updated: September 5, 2017
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2017
• Source: Nicox Ophthalmics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AC-170 0.24%

• AC-170 Vehicle

Locations

Country	Name	City	State
United States	Ora Clinical Site Network	Andover	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Nicox Ophthalmics, Inc	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Primary	Tolerability of AC 170 0.24% at Visit 2 (Day 8)	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.	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Primary	Tolerability of AC 170 0.24% at Visit 3 (Day 22)	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.	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Primary	Number of Treatment Related Adverse Events	Adverse events will be measured through study completion	up to 12 weeks