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

Allergic Conjunctivitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159769
• Other study ID #: SMA-10-13
• Status: Completed
• Phase: Phase 4
• First received: July 8, 2010
• Last updated: March 5, 2012
• Start date: June 2010
• Est. completion date: August 2010

Study information

• Verified date: March 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 12 years of age or older.

• History (within the past 24 months) of allergic conjunctivitis.

• Active signs and symptoms of ocular allergies.

• Ocular health within normal limits, as determined by the investigator or subinvestigator.

• Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Contraindications or hypersensitivity to study medication or its components.

• One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.

• Known history of recurrent corneal erosion syndrome.

• Ocular trauma or surgical intervention within 6 months prior to Visit 1.

• Participation in any other investigational study within 30 days before Visit 1.

• Pregnant or nursing.

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)
Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Patient Satisfaction	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."	Day 0	No
Primary	Overall Patient Satisfaction	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."	Day 7	No