NCT00133627

Brief Summary

Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
229

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2005

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

November 17, 2011

Status Verified

November 1, 2011

Enrollment Period

6 months

First QC Date

August 22, 2005

Last Update Submit

November 16, 2011

Conditions

Seasonal Allergic Conjunctivitis

Keywords

AllergicConjunctivitisKetotifenHistamine

Interventions

KetotifenDRUG

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 3 years or older.
  • History of seasonal allergic conjunctivitis
  • Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:
  • at least intensity degree 2 for itching, and
  • at least intensity degree 4 for composite score of itching and conjunctival hyperaemia

You may not qualify if:

  • Other systemic/ophthalmic conditions
  • Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
  • Active bacterial or viral conjunctivitis or history of ocular herpes.
  • Presence or history of severe dry eye.
  • Previous treatments
  • Any systemic or ocular corticosteroids within two (2) weeks prior to randomization.
  • Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization.
  • Any other ophthalmic medication within three (3) days prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Shanghai Medical University

Shanghai, China

Location

MeSH Terms

Conditions

Conjunctivitis

Interventions

Ketotifen

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Sun Xinghuai

    Hospital of Shanghai Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 23, 2005

Study Start

April 1, 2005

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

November 17, 2011

Record last verified: 2011-11

Locations

CN(1)