Clinical Trials Logo
  1. Home
  2. Allergic Conjunctivitis
  3. NCT00244543
  4. Details
NCT00244543 Clinical Trial

Evaluation of Efficacy of Ophthalmic Solution in Induced Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:
A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00244543
Other study ID # 05-003-13
Secondary ID
Status Completed
Phase Phase 3
First received October 25, 2005
Last updated September 26, 2011
Start date October 2005

Study information
Verified date September 2011
Source Vistakon Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date
Est. primary completion date November 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• R89674 (generic name not yet established)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Vistakon Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Ocular itching and conjunctival redness post challenge
Secondary Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge
See also
  Status Clinical Trial Phase
Completed NCT03660878 - A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis Phase 1/Phase 2
Completed NCT03682965 - Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study Phase 2
Completed NCT01697969 - Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Phase 4
Completed NCT01685242 - A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle Phase 3
Completed NCT01439815 - An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo Phase 4
Completed NCT01294969 - Patient Perception Study for AL-4943A Phase 4
Completed NCT01471184 - The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo Phase 1
Completed NCT00609128 - Effect of Olopatadine on Allergic Tear Mediators N/A
Recruiting NCT05969236 - A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults Phase 1
Active, not recruiting NCT04619017 - Airway Immune Response to Allergens (Use Lay Language Here) Phase 1
Not yet recruiting NCT01012752 - A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts Phase 3
Completed NCT01754766 - AGN-229666 for the Treatment of Allergic Conjunctivitis Phase 2
Completed NCT01698814 - A Six-Week Safety Study of an Investigational Ophthalmic Solution Phase 3
Completed NCT01443442 - Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis Phase 4
Completed NCT01203540 - Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients Phase 4
Completed NCT00987272 - Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects Phase 3
Completed NCT00769886 - Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis. Phase 3
Completed NCT00534794 - Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis Phase 4
Completed NCT00586625 - Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers Phase 3
Completed NCT00569777 - Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers Phase 3