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

Phase 3

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: AC-170 0.24%; Drug: AC-170 Vehicle

• Registration Number: NCT02756624
• Lead Sponsor: Nicox Ophthalmics, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-26
• Study First Posted: 2016-04-29
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2017-06-27
• Results First Submitted QC: 2017-06-27
• Results First Posted: 2017-07-26
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 516

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC-170 0.24%	AC-170 0.24%	1 drop in each eye 3 times daily for up to 6 weeks
AC-170 Vehicle	AC-170 Vehicle	1 drop in each eye 3 times daily for up to 6 weeks

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ora Clinical Site Network; 🇺🇸 Andover, Massachusetts, United States