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

NCT02132169 | Completed Phase 3 Results

• 1 other identifier: 14-100-0006
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 1

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).

Conditions

Atopic Disease (Including Allergic Conjunctivitis)

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Safety of AC 170 0.024% Compared to Its Vehicle

  Up to 12 Weeks

Study Arms (2)

AC-170 0.24%

EXPERIMENTAL

Drug: Drug: AC-170 0.24%

AC-170 0%

PLACEBO COMPARATOR

Drug: AC-170 0%

Interventions

Drug: AC-170 0.24% DRUG

Also known as: 1 drop in each eye 2 times daily for up to 6 weeks

AC-170 0.24%

AC-170 0% DRUG

Also known as: 1 drop in each eye 2 times daily for up to 6 weeks

AC-170 0%

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aciex Therapeutics, Inc.: lead

Study Sites (1)

Ora, Inc.

Andover, Massachusetts, 01810, United States

Location

Results Point of Contact

• Title: Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President
• Organization: Nicox Ophthalmics Inc.

bergamini@nicox.com

817-529-9315

Study Officials

• Stacey L Ackerman, MD

  Philadelphia Eye Associates

  PRINCIPAL INVESTIGATOR

• Dawn K De Castro, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

• Edward J Meier, MD

  Apex Eye

  PRINCIPAL INVESTIGATOR

• Eugene E Protzko, MD

  Seidenberg Protzko Eye Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 7, 2014
• Study Start: May 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 11, 2017
• Results First Posted: July 26, 2017

Record last verified: 2017-09

Locations

US (1)