Trial Outcomes & Findings for Assessment of Alcon's Ocular Image Quantification System (NCT NCT01282138)

NCT ID: NCT01282138

Last Updated: 2012-12-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: Baseline, 3 hours
• Results posted on: 2012-12-18

Participant Flow

Subjects were recruited from one study center in Canada.

Participant milestones

Measure	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.	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.
EEC STARTED	6	7
EEC COMPLETED	6	7
EEC NOT COMPLETED	0	0
CAPT STARTED	6	7
CAPT COMPLETED	6	7
CAPT NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Alcon's Ocular Image Quantification System

Baseline characteristics by cohort

Measure	Patanol n=6 Participants 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.	Tears Naturale II n=7 Participants 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 n=13 Participants Total of all reporting groups
Age Continuous	36.0 years STANDARD_DEVIATION 10.4 • n=5 Participants	39.9 years STANDARD_DEVIATION 11.2 • n=7 Participants	38.1 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment Canada	6 participants n=5 Participants	7 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 hours

Population: All enrolled participants

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.

Outcome measures

Measure	Patanol n=12 eyes 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.	Tears Naturale II n=14 eyes 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.
Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours	-1.63 Units on a scale Standard Error 0.6	-1.11 Units on a scale Standard Error 0.2

PRIMARY outcome

Timeframe: Baseline, 3 hours

Population: All enrolled participants

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.

Outcome measures

Measure	Patanol n=12 eyes 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.	Tears Naturale II n=14 eyes 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.
Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours	-0.38 Units on a scale Standard Error 0.6	-1.15 Units on a scale Standard Error 0.5

Adverse Events

Patanol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tears Naturale II

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Patanol n=6 participants at risk 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.	Tears Naturale II n=7 participants at risk 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.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/6 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.	14.3% 1/7 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Intermittent Bronchospasm	0.00% 0/6 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.	14.3% 1/7 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.
Infections and infestations Hordeolum Right Eye	0.00% 0/6 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.	14.3% 1/7 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.
Respiratory, thoracic and mediastinal disorders Shortness of Breath	0.00% 0/6 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.	14.3% 1/7 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.
Eye disorders Blepharospasm	0.00% 0/6 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.	14.3% 1/7 • Adverse events were collected for the duration of the study: 3 months, 1 week, 6 days. This reporting group includes all enrolled subjects.

Additional Information

Head, Global Medical Affairs

Alcon Research

Phone: 1-800-862-5266

Email: medinfo@alconlabs.com

Results disclosure agreements

• Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER