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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01272089
Enrollment
300
Registered
2011-01-07
Start date
2011-05-31
Completion date
2011-12-31
Last updated
2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Brief 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.

Interventions

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

Sponsors

Alcon Research
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Overall Patient SatisfactionDay 7As assessed by the subject on a questionnaire

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026