Clinical Trials Logo
  1. Home
  2. Allergic Conjunctivitis
  3. NCT00445874
  4. Details
NCT00445874 Clinical Trial

Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in the Treatment of Allergic Conjunctivitis

Allergic Conjunctivitis Clinical Trial

Official title:
A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00445874
Other study ID # 06-003-23
Secondary ID
Status Completed
Phase Phase 3
First received March 7, 2007
Last updated April 8, 2009
Start date February 2007
Est. completion date May 2007

Study information
Verified date April 2009
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 evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 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 withing the past 24 months

- Successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more

Exclusion Criteria:

- Active ocular infection

- Clinically significant blepharitis

- Follicular conjunctivitis

- Pterygium

- Narrow angle glaucoma

- Dry eye dyndrome

- Ocular surgery within past 6 months

- Pregnancy or lactation

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Ketotifen with a Contact Lens (no generic name)

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
Secondary Conjunctival, ciliary, and episcieral redness; chemosis and mucous discharge; tearing and lid swelling
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 NCT01685242 - A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle Phase 3
Completed NCT01697969 - Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Phase 4
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 NCT01698814 - A Six-Week Safety Study of an Investigational Ophthalmic Solution Phase 3
Completed NCT01754766 - AGN-229666 for the Treatment of Allergic Conjunctivitis Phase 2
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 NCT00586625 - Safety Study for Bepotastine Besilate Ophthalmic Solution in Normal Volunteers Phase 3
Completed NCT00586664 - Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis Phase 3
Completed NCT00534794 - Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis Phase 4