NCT01435460

Brief Summary

This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
6 months until next milestone

Results Posted

Study results publicly available

March 13, 2012

Completed
Last Updated

March 13, 2012

Status Verified

February 1, 2012

Enrollment Period

8 months

First QC Date

September 14, 2011

Results QC Date

February 17, 2012

Last Update Submit

February 17, 2012

Conditions

Seasonal Allergic Conjunctivitis

Keywords

ocular allergy

Outcome Measures

Primary Outcomes (2)

  • Bulbar Conjunctival Injection

    Bulbar conjunctival injection (sign) evaluated using a grading scale from 0-3: where 0 = Absent and 3 = Severe

    Change from baseline to day 15 (visit 3)

  • Ocular Itching

    Ocular itching (symptom) evaluated using a grading scale from 0-4 where 0 = Absent and 4 = Severe

    Change from baseline to day 15 (visit 3)

Secondary Outcomes (2)

  • Bulbar Conjunctival Injection

    Change from baseline to day 8 (visit 2)

  • Ocular Itching

    Change from baseline to day 8 (visit 2)

Study Arms (2)

Alrex

EXPERIMENTAL

Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%

Drug: Loteprednol etabonate 0.2%

Patanol

ACTIVE COMPARATOR

Ophthalmic solution containing olopatadine, 0.1%

Drug: Olopatadine 0.1%

Interventions

Loteprednol etabonate 0.2%DRUG

1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.

Also known as: Alrex
Alrex
Olopatadine 0.1%DRUG

1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.

Also known as: Patanol
Patanol

Eligibility Criteria

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

You may qualify if:

  • Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.

You may not qualify if:

  • Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
  • Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
  • Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
  • Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb Singapore

Singapore, Singapore, 556741, Singapore

Location

Related Publications (1)

  • Gong L, Sun X, Qu J, Wang L, Zhang M, Zhang H, Wang L, Gu Y, Elion-Mboussa A, Roy L, Zhu B. Loteprednol etabonate suspension 0.2% administered QID compared with olopatadine solution 0.1% administered BID in the treatment of seasonal allergic conjunctivitis: a multicenter, randomized, investigator-masked, parallel group study in Chinese patients. Clin Ther. 2012 Jun;34(6):1259-1272.e1. doi: 10.1016/j.clinthera.2012.04.024. Epub 2012 May 23.

    PMID: 22627057DERIVED

MeSH Terms

Interventions

Loteprednol EtabonateOlopatadine Hydrochloride

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDibenzoxepinsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Tuyen Ong
Organization
Bausch & Lomb, Incorporated
tuyen.ong@bausch.com
(973) 360-6389

Study Officials

  • Esther Chu

    Bausch & Lomb Incorporated

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 16, 2011

Study Start

August 1, 2010

Primary Completion

April 1, 2011

Study Completion

May 1, 2011

Last Updated

March 13, 2012

Results First Posted

March 13, 2012

Record last verified: 2012-02

Locations

SG(1)