NCT01258309

Brief Summary

This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_3

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

December 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

1 month

First QC Date

December 9, 2010

Last Update Submit

January 24, 2012

Conditions

Rhinitis, Allergic, SeasonalConjunctivitis, Allergic

Outcome Measures

Primary Outcomes (1)

  • Ocular Itching

    Day 21

Secondary Outcomes (3)

  • Hyperemia

    Day 21

  • Chemosis

    Day 21

  • Ocular mucous discharge

    Day 21

Study Arms (2)

1

EXPERIMENTAL

olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution

2

ACTIVE COMPARATOR

olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Drug: olopatadine hydrochloride 0.1% ophthalmic solution

Interventions

olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solutionDRUG

One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.

1
olopatadine hydrochloride 0.1% ophthalmic solutionDRUG

One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.

Also known as: Patanol®
2

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of seasonal allergic conjunctivitis

You may not qualify if:

  • Ocular infection or history of ocular herpes infection
  • History of retinal detachment or diabetic retinopathy
  • Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines
  • Ocular surgery within 8 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bangalore, Karnataka, India

Location

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalConjunctivitis, Allergic

Interventions

Olopatadine HydrochlorideKetorolac TromethamineOphthalmic Solutions

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesConjunctivitisConjunctival DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

DibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsIndomethacinIndolesHeterocyclic Compounds, 2-RingPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2010

First Posted

December 10, 2010

Study Start

December 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 25, 2012

Record last verified: 2012-01

Locations

IN(1)