A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:

A Multi-Site, Open-Label Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272089
• Other study ID #: C-11-013
• Status: Completed
• Phase: Phase 4
• First received: January 5, 2011
• Last updated: September 16, 2012
• Start date: May 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate subject perceptions of Olopatadine 0.2%, dosed once-daily, in subjects with allergic conjunctivitis and to record any adverse events as described by the subjects as a part of this post marketing surveillance study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• Willing to avoid contact lens wear for each of the study visits, immediately prior to study medication installation and for 10 minutes after installation of study drug.

• Contact lens wear should be stable and consistent for 3 months prior to Screening Visit (Day 1).

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the study medication or its components.

• Inability or unwillingness to follow all study instructions and complete study visits as required.

• Subjects with only one sighted eye or not correctable (using ETDRS chart) to 0.6 log MAR or better in both eyes at the Screening Visit.

• A known history of recurrent corneal erosion syndrome (idiopathic or secondary to dry eye).

• Ocular trauma within six months prior to Visit 1 in either eye as determined by subject history and/or examination.

• 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%
Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Patient Satisfaction	As assessed by the subject on a questionnaire	Day 7	No