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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.

M

Mati Therapeutics

Status and phase

Terminated
Phase 2

Conditions

Seasonal Allergic Conjunctivitis to Ragweed

Treatments

Drug: Olopatadine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01287338
141741 (Other Identifier)
PP0 AC 01

Details and patient eligibility

About

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.

Enrollment

143 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

143 participants in 2 patient groups

Lower Puncta Delivery
Experimental group
Treatment:
Drug: Olopatadine
Drug: Olopatadine
Double Puncta Delivery
Experimental group
Treatment:
Drug: Olopatadine
Drug: Olopatadine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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