A Multi-Center Study Evaluating the Safety of AC-170 0.24%

Phase 3

Completed

• Conditions: Atopic Disease (Including Allergic Conjunctivitis)
• Interventions: Drug: AC-170 0%

• Registration Number: NCT02132169
• Lead Sponsor: Aciex Therapeutics, Inc.

Brief Summary

The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-29
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-07
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Disposition First Submitted: 2015-04-30
• Disposition First Submitted QC: 2015-04-30
• Disposition First Posted: 2015-05-19
• 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: 512

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC-170 0%	AC-170 0%	-

Primary Outcome Measures

Name	Time	Method
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation	Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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% Compared to Its Vehicle at Visit 2 (Day 8)	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation	Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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% Compared to Its Vehicle at Visit 3 (Day 22)	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation	Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.

Secondary Outcome Measures

Name	Time	Method
Safety of AC 170 0.024% Compared to Its Vehicle	Up to 12 Weeks	Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients).

Trial Locations

Locations (1)

Ora, Inc.; 🇺🇸 Andover, Massachusetts, United States