A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis

This study has been withdrawn prior to enrollment.
(Study withdrawn without starting or enrolling subjects due to a business decision to not proceed with the project.)
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
First received: September 12, 2006
Last updated: February 19, 2015
Last verified: February 2015
This study will evaluate the safety and efficacy of a new allergy medication

Condition Intervention Phase
Allergic Conjunctivitis
Drug: Ketotifen/vasoconstrictor
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Official Title: Study Withdrawn Prior to Determining Official Title

Resource links provided by NLM:

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Safety and efficacy of a new allergy medication [ Time Frame: 0 ] [ Designated as safety issue: No ]

Enrollment: 0
Detailed Description:
Study withdrawn prior to determining study details

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Be at least 6 years of age, of any race, or either gender.
  • Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
  • Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
  • Positive bilateral CAC reaction at Visit 1 & 2.

Exclusion Criteria:

  • Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
  • Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
  • Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00375596     History of Changes
Other Study ID Numbers: C-02-06-001 
Study First Received: September 12, 2006
Last Updated: February 19, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on May 25, 2016