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A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01551056
First Posted: March 12, 2012
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Aciex Therapeutics, Inc.
Results First Submitted: June 27, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Allergic Conjunctivitis
Interventions: Drug: AC-170 0.24%
Drug: AC-170 0%

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from three sites in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There were 91 subjects enrolled, 2 subjects discontinued, and 89 subjects completed the study. Participant flow and baseline characteristics are presented for the 91 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.

Reporting Groups
  Description
AC-170 0.24% AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
AC-170 0% AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period

Participant Flow:   Overall Study
    AC-170 0.24%   AC-170 0%
STARTED   46   45 
COMPLETED   44   45 
NOT COMPLETED   2   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AC-170 0.24% AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period
AC-170 0% AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Total Total of all reporting groups

Baseline Measures
   AC-170 0.24%   AC-170 0%   Total 
Overall Participants Analyzed 
[Units: Participants]
 46   45   91 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.6  (14.95)   38.1  (14.08)   37.4  (14.47) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  52.2%      28  62.2%      52  57.1% 
Male      22  47.8%      17  37.8%      39  42.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      12  26.1%      13  28.9%      25  27.5% 
Not Hispanic or Latino      34  73.9%      32  71.1%      66  72.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      7  15.2%      7  15.6%      14  15.4% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      9  19.6%      5  11.1%      14  15.4% 
White      30  65.2%      33  73.3%      63  69.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   46   45   91 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 3, 5, 7 minutes post-CAC ]

2.  Primary:   Ocular Itching at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 3, 5, 7 minutes post-CAC ]

3.  Primary:   Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

4.  Primary:   Conjunctival Redness at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

5.  Secondary:   Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

6.  Secondary:   Ciliary Redness at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

7.  Secondary:   Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

8.  Secondary:   Episcleral Redness at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

9.  Secondary:   Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

10.  Secondary:   Chemosis at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

11.  Secondary:   Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

12.  Secondary:   Eyelid Swelling at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

13.  Secondary:   Tearing at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

14.  Secondary:   Tearing at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

15.  Secondary:   Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

16.  Secondary:   Rhinorrhea at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

17.  Secondary:   Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

18.  Secondary:   Nasal Pruritis at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

19.  Secondary:   Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

20.  Secondary:   Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

21.  Secondary:   Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

22.  Secondary:   Nasal Congestion at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

23.  Secondary:   Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

24.  Secondary:   Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose)   [ Time Frame: 7, 15, 20 minutes post-CAC ]

25.  Secondary:   Tolerability of Study Medication at Visit 3A   [ Time Frame: upon instillation, 1 minute and 2 minutes post instillation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President
Organization: Nicox Ophthalmics Inc.
phone: 817-529-9315
e-mail: bergamini@nicox.com



Responsible Party: Aciex Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01551056     History of Changes
Other Study ID Numbers: 11-100-0012
First Submitted: March 8, 2012
First Posted: March 12, 2012
Results First Submitted: June 27, 2017
Results First Posted: October 3, 2017
Last Update Posted: November 7, 2017