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Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

V

Vistakon Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Allergic Conjunctivitis

Treatments

Drug: R89674 (generic name not yet established)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00241319
05-003-11

Details and patient eligibility

About

The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Sex

All

Ages

10+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • history of ocular allergies and a positive skin test reaction to cat hair,
  • cat dander, grasses, ragweed, and/or trees within the past 24 months;
  • calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction

Exclusion criteria

  • narrow angle glaucoma,
  • clinically significant blepharitis, follicular conjunctivitis, iritis
  • pterygium or diagnosis of dry eye
  • ocular surgical intervention within 3 months
  • history of refractive surgery within 6 months
  • known history of retinal detachment, diabetic retinopathy, or progressive retinal disease
  • presence of active ocular infection positive history of an ocular herpetic infection
  • preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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