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NCT00331500 Clinical Trial

Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:
A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00331500
Other study ID # C-04-60
Secondary ID
Status Completed
Phase Phase 3
First received May 30, 2006
Last updated August 10, 2017
Start date April 18, 2006
Est. completion date July 27, 2006

Study information
Verified date June 2008
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.

Recruitment information / eligibility
Status Completed
Enrollment 287
Est. completion date July 27, 2006
Est. primary completion date July 27, 2006
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility Inclusion Criteria:

- History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

Exclusion Criteria:

- Under 10 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Olopatadine Hydrochloride Ophthalmic Solution, 0.2%

• Olopatadine Hydrochloride Ophthalmic Solution Vehicle
Inactive ingredients used as a placebo comparator

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

References & Publications (1)

Bilson JD, Lapworth SJ. J.S. Athertya, G. Saravana Kumar, "Automatic segmentation of vertebral contours from CT images using fuzzy corners" [Comput. Biol. Med. 72 (May 1, 2016) 75-89, https://www.ncbi.nlm.nih.gov/pubmed/27017068]. Comput Biol Med. 2017 Ju — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Daily ocular itching and redness scores Up to Day 14
Secondary Percentage of patients with daily ocular itching and redness scores of 0 Up to Day 14
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