A Study to Evaluate the Safety and Efficacy of the QLT Proprietary Olopatadine-PPDS in Subjects With Seasonal Allergic Conjunctivitis to Ragweed in an Environmental Exposure Chamber Model.

NCT01287338 | Terminated Phase 2

• 2 other identifiers: PP0 AC 01141741
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test if olopatadine punctal plugs can reduce the symptoms (itching) of allergic conjunctivitis to ragweed in an Environmental Exposure Chamber model.

Conditions

Seasonal Allergic Conjunctivitis to Ragweed

Outcome Measures

Primary Outcomes (2)

• Safety of olopatadine-PPDS in subjects with seasonal allergic conjunctivitis to ragweed

  4 Days

• Change from baseline in subject-rated ocular itching scores in treated vs placebo control arms in subjects with seasonal allergic conjunctivitis to ragweed

  4 days

Secondary Outcomes (1)

• Change from baseline and observed values in subject rated ocular itching scores compared between lower puncta delivery and double puncta delivery arms

  4

Study Arms (2)

Lower Puncta Delivery

EXPERIMENTAL

Drug: Olopatadine

Double Puncta Delivery

EXPERIMENTAL

Drug: Olopatadine

Interventions

Olopatadine DRUG

low dose

Lower Puncta Delivery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of allergic conjunctivitis to ragweed for at least one year
• Positive skin prick test to ragweed pollen within 12 months prior to visit 1
• BCVA of at leat 20/400

You may not qualify if:

• Structural lid abnormalities (ectropion, entropion)
• Active lid disease ( ie moderate or severe blepharitis, meibomianitis) that requires medical treatment
• Presence of follicular conjunctivitis, anterior uveitis or preauricular lymphadenopathy
• History of ophthalmic abnormality, including a history of dry eye
• Perennial allergic rhinoconjunctivitis having significant allergy to animal dander that cannot be avoided during the study period
• History of chronic bacterial or viral ocular infection, such as herpes keratitis, and/or presence of active bacterial or viral ocular infection
• presence of mucous discharge, excess lacrimation or burning as a symptoms of ocular disease
• Currently on any chronic ocular topical medications
• Use of topical or systemic ocular medications during the study period
• History of complications, adverse events, trauma or disease in the nasolacrimal area
• History of symptomatic epiphoria

Sponsors & Collaborators

• Mati Therapeutics Inc.: lead

Study Sites (1)

Cetero Research

Toronto, Ontario, Canada

Location

MeSH Terms

Interventions

Olopatadine Hydrochloride

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Dipak Panigrahi, MD

  QLT Inc.

  STUDY DIRECTOR

• Deepen Patel, MD

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2011
• First Posted: February 1, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

CA (1)