Assessment of Alcon's Ocular Image Quantification System

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01282138
• Collaborator: (none)
• Enrollment: 13
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol); Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)	Phase 4

Detailed Description

Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects received the second study treatment and used as instructed for 5 days, after which a 3-hour Conjunctival Allergen Provocation Test (CAPT) was performed with an escalating concentration of the allergen. Subjects dosed with study treatment approximately 15 minutes prior to each allergen provocation test.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: A Study to Assess Alcon's Ocular Image Quantification Using Conjunctival Allergan Provocation Testing (CAPT) and Natural Allergen Exposure in an Environmental Exposure Chamber (EEC)
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patanol 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.	Drug: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol); One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.; Other Names: Patanol®
Placebo Comparator: Tears Naturale II 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.	Other: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II); One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.; Other Names: Tears Naturale II

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours [Baseline, 3 hours]

   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.

2. Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours [Baseline, 3 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• History of allergic conjunctivitis;

• Active signs and symptoms of ocular allergies;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• History of dry eye;

• Presence of ocular infection;

• Presence of severe or serious ocular conditions;

• Symptoms of allergic conjunctivitis;

• Use of topical or systemic ocular medications as specified in protocol;

• Ocular surgery or laser surgery within 6 months of study start;

• Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01282138
• Other Study ID Numbers: RDG-10-278
• First Posted: Jan 24, 2011
• Last Update Posted: Dec 18, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by Alcon Research: Allergic conjunctivitis
• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Olopatadine Hydrochloride; Dextrans; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from one study center in Canada.

Arm/Group Title	Patanol	Tears Naturale II
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: EEC
STARTED	6	7
COMPLETED	6	7
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Patanol	Tears Naturale II	Total
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 Participants	6	7	13
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.0 (10.4)	39.9 (11.2)	38.1 (10.6)
Sex: Female, Male (Count of Participants)
Female	4 66.7%	2 28.6%	6 46.2%
Male	2 33.3%	5 71.4%	7 53.8%
Region of Enrollment (participants) [Number]
Canada	6 100%	7 100%	13 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours
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

Outcome Measure Data

Analysis Population Description

All enrolled participants

Arm/Group Title	Patanol	Tears Naturale II
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.
Measure Participants	6	7
Measure eyes	12	14
Mean (Standard Error) [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
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

Outcome Measure Data

Analysis Population Description

All enrolled participants

Arm/Group Title	Patanol	Tears Naturale II
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.
Measure Participants	6	7
Measure eyes	12	14
Mean (Standard Error) [Units on a scale]	-0.38 (0.6)	-1.15 (0.5)

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Patanol		Tears Naturale II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Patanol		Tears Naturale II
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		2/7 (28.6%)
Eye disorders
Blepharospasm	0/6 (0%)		1/7 (14.3%)
Infections and infestations
Upper Respiratory Tract Infection	0/6 (0%)		1/7 (14.3%)
Hordeolum Right Eye	0/6 (0%)		1/7 (14.3%)
Respiratory, thoracic and mediastinal disorders
Intermittent Bronchospasm	0/6 (0%)		1/7 (14.3%)
Shortness of Breath	0/6 (0%)		1/7 (14.3%)

Limitations/Caveats

This was a pilot study with a small number of subjects not adequately powered to detect treatment differences.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Alcon reserves the right of prior review of any publication or presentation of information related to the study.