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

Atopic Disease (Including Allergic Conjunctivitis) Clinical Trial

Official title:

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 0.24% Ophthalmic Solution Used Twice Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132169
• Other study ID #: 14-100-0006
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2014
• Last updated: September 5, 2017
• Start date: May 2014
• Est. completion date: October 2014

Study information

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

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• 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

Related Conditions & MeSH terms

• Atopic Disease (Including Allergic Conjunctivitis)
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Drug: AC-170 0.24%

• AC-170 0%

Locations

Country	Name	City	State
United States	Ora, Inc.	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aciex Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)	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.	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Primary	Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8)	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.	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Primary	Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22)	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.	Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Secondary	Safety of AC 170 0.024% Compared to Its Vehicle	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).	Up to 12 Weeks