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Trial record 24 of 248 for:    test AND provocation

Assessment of Alcon's Ocular Image Quantification System

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: NCT01282138
Recruitment Status : Completed
First Posted : January 24, 2011
Results First Posted : July 25, 2012
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Diagnostic
Condition Allergic Conjunctivitis
Interventions Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)
Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
Enrollment 13
Recruitment Details Subjects were recruited from one study center in Canada.
Pre-assignment Details  
Arm/Group Title Patanol Tears Naturale II
Hide Arm/Group Description One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Period Title: EEC
Started 6 7
Completed 6 7
Not Completed 0 0
Period Title: CAPT
Started 6 7
Completed 6 7
Not Completed 0 0
Arm/Group Title Patanol Tears Naturale II Total
Hide Arm/Group Description One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. Total of all reporting groups
Overall Number of Baseline Participants 6 7 13
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 13 participants
36.0  (10.4) 39.9  (11.2) 38.1  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 13 participants
Female
4
  66.7%
2
  28.6%
6
  46.2%
Male
2
  33.3%
5
  71.4%
7
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 6 participants 7 participants 13 participants
6 7 13
1.Primary Outcome
Title Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
Hide Description As assessed by the participant after 3 hours in the EEC. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Time Frame Baseline, 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Patanol Tears Naturale II
Hide Arm/Group Description:
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Overall Number of Participants Analyzed 6 7
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 14
Mean (Standard Error)
Unit of Measure: Units on a scale
-1.63  (0.6) -1.11  (0.2)
2.Primary Outcome
Title Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours
Hide Description As assessed by the participant after 3 hours of CAPT. Ocular itching was graded on a 0-4 scale, where 0=none, 1=tickling sensation involving one or more corners of the eye, 2=all over tickling sensation; 3=moderate continuous itching with desire to rub; 4=severe itching with irresistible urge to rub.
Time Frame Baseline, 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants
Arm/Group Title Patanol Tears Naturale II
Hide Arm/Group Description:
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
Overall Number of Participants Analyzed 6 7
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
12 14
Mean (Standard Error)
Unit of Measure: Units on a scale
-0.38  (0.6) -1.15  (0.5)
Time Frame Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days.
Adverse Event Reporting Description This reporting group includes all enrolled subjects.
 
Arm/Group Title Patanol Tears Naturale II
Hide Arm/Group Description One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
All-Cause Mortality
Patanol Tears Naturale II
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Patanol Tears Naturale II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Patanol Tears Naturale II
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   2/7 (28.57%) 
Eye disorders     
Blepharospasm 1 [1]  0/6 (0.00%)  1/7 (14.29%) 
Infections and infestations     
Upper Respiratory Tract Infection 1 [1]  0/6 (0.00%)  1/7 (14.29%) 
Hordeolum Right Eye 1 [1]  0/6 (0.00%)  1/7 (14.29%) 
Respiratory, thoracic and mediastinal disorders     
Intermittent Bronchospasm 1 [1]  0/6 (0.00%)  1/7 (14.29%) 
Shortness of Breath 1 [1]  0/6 (0.00%)  1/7 (14.29%) 
1
Term from vocabulary, MedDRA
[1]
Not related
This was a pilot study with a small number of subjects not adequately powered to detect treatment differences.
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.
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Head, Global Medical Affairs
Organization: Alcon Research
Phone: 1-800-862-5266
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01282138     History of Changes
Other Study ID Numbers: RDG-10-278
First Submitted: January 20, 2011
First Posted: January 24, 2011
Results First Submitted: June 20, 2012
Results First Posted: July 25, 2012
Last Update Posted: December 18, 2012