A Multi-Center Study Evaluating the Safety of AC-170 0.24%
This study is currently recruiting participants.
(see Contacts and Locations)
Verified May 2014 by Aciex Therapeutics, Inc.
Sponsor:
Aciex Therapeutics, Inc.
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02132169
First received: April 29, 2014
Last updated: May 5, 2014
Last verified: May 2014
History of Changes
Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record
Purpose 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).
Study Type: Interventional Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment 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)
Resource links provided by NLM:
MedlinePlus related topics:
Pinkeye
U.S. FDA Resources
Further study details as provided by Aciex Therapeutics, Inc.:
Primary Outcome Measures: Tolerability of AC 170 0.24% compared to its vehicle [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ] Tolerability of AC 170 0.024% compared to its vehicle will be measured at Visit 1-3. Subjects will assess their comfort based on an approved scale.
Secondary Outcome Measures: Safety of AC 170 0.024% compared to its vehicle [ Time Frame: Up to 12 Weeks ] [ Designated as safety issue: No ] Safety measures (adverse events, etc.) of AC 170 0.024% compared to its vehicle will be measured at Visit 1-4 and 5 (for subset of patients).
Estimated Enrollment: 501 Study Start Date: May 2014 Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions Experimental: AC-170 0.24% Drug: Drug: AC-170 0.24% Other Name: 1 drop in each eye 2 times daily for up to 6 weeks
Placebo Comparator: AC-170 0% Drug: AC-170 0% Other Name: 1 drop in each eye 2 times daily for up to 6 weeks
Eligibility
Ages Eligible for Study: 2 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see
Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02132169
Contacts
Contact: Tom Cavanagh 917-969-9339
[email protected]
Locations
United States, Massachusetts Andover Eye Associates Recruiting Andover, Massachusetts, United States, 01810 Contact: Allie Griffin 978-685-8900 Sponsors and Collaborators
Aciex Therapeutics, Inc.
More Information
No publications provided