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

NCT ID: NCT01272089

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Allergic Conjunctivitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pataday

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once daily for one week

Group Type EXPERIMENTAL

Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Intervention Type DRUG

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

Interventions

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Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

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

Intervention Type DRUG

Other Intervention Names

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Pataday

Eligibility Criteria

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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).

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kolkata, , India

Site Status

Countries

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United States India

Other Identifiers

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C-11-013

Identifier Type: -

Identifier Source: org_study_id