NCT00889330

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

2 active sites

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, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

December 8, 2011

Completed
Last Updated

March 6, 2015

Status Verified

February 1, 2015

Enrollment Period

1 month

First QC Date

April 24, 2009

Results QC Date

June 24, 2011

Last Update Submit

February 18, 2015

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (4)

  • Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.

    A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.

    Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge

  • Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation

    A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.

    Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment

  • Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation

    0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"

    Visit 4 (Day 14) up to 7 minutes following Allergen Challenge

  • Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation

    A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.

    Visit 4 (Day 14) At 20 minutes following Allergen Challenge

Other Outcomes (9)

  • Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day -14

    Visit 2 (Day -14) pre-allergen challenge

  • Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 0 Pre-dose, Pre-allergen Challenge

    Visit 3 (Day 0) pre-dose, pre-allergen challenge

  • Number of Eyes With a Visual Acuity Change From Visit 1 (Day -21) at Day 14 Pre-dose, Pre-allergen Challenge

    Visit 4 (Day 14) pre-dose, pre-allergen challenge

  • +6 more other outcomes

Study Arms (2)

alcaftadine ophthalmic solution

EXPERIMENTAL

active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).

Drug: alcaftadine

inactive ophthalmic solution vehicle

PLACEBO COMPARATOR

Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14).

Drug: Placebo

Interventions

alcaftadineDRUG

0.25% Ophthalmic Solution, one drop in each eye at each of two visits.

alcaftadine ophthalmic solution
PlaceboDRUG

Vehicle without active, one drop in each eye at each of two visits.

inactive ophthalmic solution vehicle

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least 10 years of age
  • positive history of ocular allergies
  • positive skin test reaction to allergens.

You may not qualify if:

  • known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
  • ocular surgical intervention within three (3) months prior to visit 1 or during the study
  • known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
  • any other significant illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Fairfield, Ohio, United States

Location

Unknown Facility

Mason, Ohio, United States

Location

Related Publications (1)

  • Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21.

    PMID: 21250860DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

alcaftadine

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Arthur Shedden, MD
Organization
Johnson & Johnson Vision Care, Inc.
ashedden@its.jnj.com
904-443-1557

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2009

First Posted

April 28, 2009

Study Start

April 1, 2009

Primary Completion

May 1, 2009

Last Updated

March 6, 2015

Results First Posted

December 8, 2011

Record last verified: 2015-02

Locations

US(2)