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Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

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.
 
ClinicalTrials.gov Identifier: NCT01697969
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : August 18, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Allergic Conjunctivitis
Intervention Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Enrollment 17
Recruitment Details Participants were recruited from 1 study center located in the United States.
Pre-assignment Details Of the 17 participants enrolled, 4 were exited from the study as screen failures prior to exposure to the test product. This reporting group includes all participants exposed to the test product (13).
Arm/Group Title Overall Study
Hide Arm/Group Description Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
Period Title: Overall Study
Started 13
Completed 10
Not Completed 3
Reason Not Completed
Did not meet inc/exc criteria             3
Arm/Group Title Overall Study
Hide Arm/Group Description Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
This analysis population includes all participants exposed to the test product.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
37.0  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
11
  84.6%
Male
2
  15.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Patient-Assessed Ocular Itching
Hide Description The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.
Time Frame Baseline (Day 1), Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population includes all participants exposed to the test product. Here, “n” is the number of participants with non-missing values at the specific time point.
Arm/Group Title Left Eye Right Eye
Hide Arm/Group Description:
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
Overall Number of Participants Analyzed 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline (Day 1) 2.2  (0.85) 2.2  (0.92)
Day 14 (n=11) 0.5  (0.52) 0.5  (0.52)
Time Frame Adverse events were collected for the duration of the study (October 11, 2012 to July 25, 2013). This analysis group includes all participants exposed to the test product.
Adverse Event Reporting Description At each visit, after the subject had the opportunity to spontaneously mention any problems, the investigator inquired about AEs by asking the standard questions, "Have you had any health problems since your last study visit? Have there been any changes in the medicines you take since your last study visit?”
 
Arm/Group Title Overall Study
Hide Arm/Group Description Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
All-Cause Mortality
Overall Study
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Overall Study
Affected / at Risk (%)
Total   0/13 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Overall Study
Affected / at Risk (%)
Total   1/13 (7.69%) 
Infections and infestations   
Arthropod infestation  1  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.1
The lack of concurrent control made it difficult to discriminate changes caused by PATADAY® from that caused by other factors, such as observer or patient expectation. Open-labeled design increased the bias from the observer or patient expectation.
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.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Danyel Crout Carr, MS, CCRA
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01697969    
Other Study ID Numbers: M-12-047
First Submitted: September 27, 2012
First Posted: October 2, 2012
Results First Submitted: July 30, 2014
Results First Posted: August 18, 2014
Last Update Posted: August 18, 2014