NCT01332188 (AC-170) is a Phase 2/Phase 3 clinical trial of AC-170 0.05% in Allergic Conjunctivitis, sponsored by Aciex Therapeutics, Inc..

Who is sponsoring NCT01332188?

NCT01332188 is sponsored by Aciex Therapeutics, Inc..

What drugs are being tested in NCT01332188?

Interventions in NCT01332188: AC-170 0.05%, AC-170 0.1%, AC-170 0.24%, AC-170 0%.

What condition does NCT01332188 study?

NCT01332188 studies Allergic Conjunctivitis.

Is NCT01332188 still recruiting?

NCT01332188 is currently completed. Last updated 31 July 2017.

Are results published for NCT01332188?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-07-31 · How we verify

NCT01332188: AC-170

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Efficacy of Three Different Concentrations of Cetirizine (0.05%, 0.1%, and 0.24%) Ophthalmic Solution Versus Vehicle in the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge Model (CAC)

Completed Phase 2/Phase 3 Results posted Last updated 31 July 2017

What this trial tests

Phase 2/Phase 3 trial testing AC-170 0.05% in Allergic Conjunctivitis in 101 participants. Completed in 1 October 2011.

Timeline

1 April 2011

Primary endpoint
1 June 2011

1 October 2011

Quick facts

Lead sponsor	Aciex Therapeutics, Inc.
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	101
Start date	1 April 2011
Primary completion	1 June 2011
Estimated completion	1 October 2011
Sites	1 location across United States

Drugs / interventions tested

AC-170 0.05% — full drug profile →
AC-170 0.1% — full drug profile →
AC-170 0.24% — full drug profile →
AC-170 0% — full drug profile →

Conditions studied

Allergic Conjunctivitis — all drugs for Allergic Conjunctivitis →

Sponsor

Aciex Therapeutics, Inc. — full company profile →

Who can join

10 and older, any sex, with Allergic Conjunctivitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Ocular Itching at Duration of Action (16 Hours Post-dose)
Time frame: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 16 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Duration of Action (24 Hours Post-dose)
Time frame: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 24 hours after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Ocular Itching at Onset of Action (15 Minutes Post-dose)
Time frame: 3, 5, 7 minutes post-CAC
A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.
Conjunctival Redness at Duration of Action (16 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 16 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Conjunctival Redness at Duration of Action (24 Hours Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 24 hours after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)
Time frame: 7, 15, 20 minutes post-CAC
A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.

Sponsor's own description

The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) Model.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Allergic Conjunctivitis

Currently open trials in the same condition.

NCT07309432 — Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy · Phase 3 · recruiting
NCT06686472 — Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01332188 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aciex Therapeutics, Inc.
Last refreshed: 31 July 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01332188.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing