Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00770133
First received: October 8, 2008
Last updated: November 22, 2013
Last verified: November 2013

October 8, 2008
November 22, 2013
February 2010
April 2010   (final data collection date for primary outcome measure)
  • Ocular itching [ Time Frame: 3, 5 and 7 minutes post-challenge ] [ Designated as safety issue: No ]
  • Conjunctival redness [ Time Frame: 7, 15 and 20 minutes post-challenge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00770133 on ClinicalTrials.gov Archive Site
Ciliary and episcleral redness, chemosis, lid swelling, tearing and ocular mucus discharge. [ Time Frame: 7, 15 and 20 minutes post challenge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Conjunctivitis
  • Drug: Ketotifen/naphazoline
    One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
  • Drug: Naphazoline
    One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
  • Drug: Ketotifen
    One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
  • Drug: Vehicle
    One drop of vehicle ophthalmic solution at visit 3 and visit 4.
  • Experimental: Ketotifen/naphazoline
    Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
    Intervention: Drug: Ketotifen/naphazoline
  • Placebo Comparator: Vehicle
    Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
    Intervention: Drug: Vehicle
  • Active Comparator: Naphazoline
    Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
    Intervention: Drug: Naphazoline
  • Active Comparator: Ketotifen
    Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
    Intervention: Drug: Ketotifen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
133
June 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Positive history of ocular allergies and 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 0.7 logMAR or better in each eye as measured using the ETDRS chart.
  • Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
  • Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion Criteria:

  • Known contraindications or sensitivities to the study medication or its components.
  • Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
  • Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00770133
572
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Laura Trusso Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP