NCT01294969

Brief Summary

To evaluate patient perceptions of Al-4943 in subjects with allergic conjunctivitis previously treated with a topical ocular anti-allergy leukotriene-release inhibitor medication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2010

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

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 16, 2016

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

February 10, 2011

Last Update Submit

December 15, 2016

Conditions

Allergic Conjunctivitis

Keywords

Allergic conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Overall Patient satisfaction

    7 days

Study Arms (1)

AL-4943A

EXPERIMENTAL

One drop per day in both eyes

Drug: AL-4943A

Interventions

AL-4943ADRUG

Once daily topical ocular allergy medication used for 7 days

AL-4943A

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • History of allergic conjunctivitis within last 24 months
  • Active signs and symptoms of ocular allergies

You may not qualify if:

  • Severe or serious ocular condition, ocular surgical intervention, ocular infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Korea Ltd.

Seoul, 06181, South Korea

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 14, 2011

Study Start

September 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 16, 2016

Record last verified: 2011-10

Locations

KR(1)