NCT00534794

Brief Summary

The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P25-P50 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 27, 2009

Completed
Last Updated

May 13, 2015

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

September 20, 2007

Results QC Date

January 30, 2009

Last Update Submit

April 27, 2015

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Change in Ocular Itch Score From Baseline

    Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.

    0 hours, 12 hours

Secondary Outcomes (1)

  • Ocular Comfort Score at 12 Hours

    12 hours

Study Arms (2)

Elestat

EXPERIMENTAL
Drug: Elestat

Pataday

ACTIVE COMPARATOR
Drug: Pataday

Interventions

ElestatDRUG

Elestat BID for 2 days

Elestat
PatadayDRUG

Pataday QD for 2 days

Pataday

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented history of ocular allergy to cats.
  • Positive skin prick allergen reaction to cat dander.

You may not qualify if:

  • Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.
  • History of severe asthma, reactive airway disease or bronchial obstruction.
  • Ocular surgery or trauma in the last year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

epinastineOlopatadine Hydrochloride

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
clinicaltrialsdisclosure@merck.com

Study Officials

  • Michael Raizman, MD

    Ophthalmic Consultants of Boston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 26, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2008

Last Updated

May 13, 2015

Results First Posted

May 27, 2009

Record last verified: 2015-04

Locations

US(1)