Trial Outcomes & Findings for Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis (NCT NCT01159769)

Results Overview

Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

215 participants

Primary outcome timeframe

Day 0

Results posted on

2012-04-03

Participant Flow

Patients were recruited from 12 US study centers. Eligible patients having a history of allergic conjunctivitis and treated with protocol-specified anti-allergy medications for at least 7 days within 6 months prior to Visit 1 were enrolled. Investigators reviewed files to identify patients.

215 patients were enrolled. All patients received the same treatment.

Participant milestones

Participant milestones
Measure	Olopatadine 0.2% 1 drop self-administered in each eye once daily in the morning for 7 days
Overall Study STARTED	215
Overall Study COMPLETED	214
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Olopatadine 0.2% 1 drop self-administered in each eye once daily in the morning for 7 days
Overall Study Adverse Event	1

Baseline Characteristics

Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olopatadine 0.2% n=215 Participants 1 drop self-administered in each eye once daily in the morning for 7 days
Age, Categorical <=18 years	7 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	127 Participants n=5 Participants
Age, Categorical >=65 years	81 Participants n=5 Participants
Age Continuous	55.03 years STANDARD_DEVIATION 18.58 • n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants
Sex: Female, Male Male	74 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0

Population: All subjects who used the study medication at least once (intent to treat).

Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied are you with your current eye allergy medication?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."

Outcome measures

Outcome measures
Measure	Olopatadine 0.2% n=214 Participants 1 drop self-administered in each eye once daily in the morning for 7 days
Overall Patient Satisfaction	70.1 Percentage of Participants

PRIMARY outcome

Timeframe: Day 7

Population: All subjects who used the study medication at least once (intent to treat).

Overall satisfaction was assessed by the patient on a questionnaire. The patient was instructed to select a single response to the statement, "Overall, how satisfied were you with olopatadine 0.2%?" A 5-point scale was used: very satisfied, satisfied, undecided, dissatisfied, very dissatisfied. Results are reported as the percentage of patients who responded, "very satisfied" or "satisfied."

Outcome measures

Outcome measures
Measure	Olopatadine 0.2% n=214 Participants 1 drop self-administered in each eye once daily in the morning for 7 days
Overall Patient Satisfaction	89.3 Percentage of Participants

Adverse Events

Olopatadine 0.2%

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Olopatadine 0.2% n=215 participants at risk 1 drop self-administered in each eye once daily in the morning for 7 days
Gastrointestinal disorders Stomach pain	0.47% 1/215 • Adverse events were collected for the duration of the study: 7 June 2010 to 7 August 2010. This reporting group includes all subjects who used the study medication at least once (intent to treat). Subjects were queried about any symptoms that would suggest an adverse event with, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"
Gastrointestinal disorders Colorectal cancer	0.47% 1/215 • Adverse events were collected for the duration of the study: 7 June 2010 to 7 August 2010. This reporting group includes all subjects who used the study medication at least once (intent to treat). Subjects were queried about any symptoms that would suggest an adverse event with, "Have you had any health problems since your last study visit?" and "Have there been any changes in the medicines you take since your last study visit?"

Other adverse events

Adverse event data not reported

Additional Information

Director of Medical Affairs

Alcon Research, Ltd.

Phone: 800-862-5266

Email: [email protected]

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