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

NCT01159769 | Completed Phase 4 Results

• 1 other identifier: SMA-10-13
• Study Type: interventional
• Target: 215
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Allergic Conjunctivitis

Keywords

Allergic conjunctivitis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Olopatadine 0.2%

EXPERIMENTAL

1 drop self-administered in each eye once daily in the morning for 7 days

Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)

Interventions

Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®) DRUG

Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis

Also known as: Pataday®

Olopatadine 0.2%

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Medical Affairs
• Organization: Alcon Research, Ltd.

medinfo@alconlabs.com

800-862-5266

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 9, 2010
• Study Start: June 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 3, 2012
• Results First Posted: April 3, 2012

Record last verified: 2012-03