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CompletedNCT01272089Updated Sep 18, 2012

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

A Phase 4 interventional study of Olopatadine Hydrochloride Ophthalmic Solution, 0.2% in Allergic Conjunctivitis, sponsored by Alcon Research. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-18.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Conjunctivitis
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 300 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Pataday

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

    Drug: Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

Interventions

  • DrugOlopatadine Hydrochloride Ophthalmic Solution, 0.2%

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

    Also known as: Pataday

06

What researchers measure

Primary outcomes

  1. Overall Patient Satisfaction

    As assessed by the subject on a questionnaire

    Time frame: Day 7

07

Study locations

1 site
  • Kolkata, 700020, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01272089
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jan 7, 2011
Start date
May 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Sep 18, 2012

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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