NCT01437982

Brief Summary

The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 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

August 5, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2015

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

5.2 years

First QC Date

September 20, 2011

Last Update Submit

November 18, 2019

Conditions

Conjunctivitis, Seasonal AllergicConjunctivitis, Giant PapillaryInflammation

Keywords

post-operative inflammationconjunctivitissafetySeasonal allergic conjunctivitisGiant papillary conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Safety

    All adverse events that occurred from the first dose of the study drug regardless of causality to the study drug. Changes in all undesirable medical findings and all adverse events occurring with the use of the study drug.

    4 years

Secondary Outcomes (3)

  • Seasonal Allergic Conjunctivitis

    4 years

  • Giant Papillary Conjunctivitis

    4 years

  • Post-operative inflammation

    4 years

Study Arms (2)

Loteprednol Etabonate

EXPERIMENTAL

Ophthalmic Gel 0.5%

Drug: Loteprednol Etabonate

Prednisolone Acetate 1% Oph Susp

EXPERIMENTAL

Ophthalmic suspension 0.5%

Drug: Prednisolone Acetate 1% Oph Susp

Interventions

Loteprednol EtabonateDRUG

Ocular administration of study drug. at least once within any indication of the label.

Also known as: Lotemax
Loteprednol Etabonate
Prednisolone Acetate 1% Oph SuspDRUG

Ocular administration of study drug. at least once within any indication of the label.

Also known as: Prednisolone Acetate
Prednisolone Acetate 1% Oph Susp

Eligibility Criteria

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

You may qualify if:

  • Subjects who have been treated with the study drug at least once and completed safety follow-up.
  • Subjects who have been treated with the study drug at least once and completed the clinical efficacy assessment.

You may not qualify if:

  • Subjects not treated with study drug at least once.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bausch & Lomb Korea Ltd

Seoul, 135-280, South Korea

Location

MeSH Terms

Conditions

ConjunctivitisConjunctivitis, AllergicInflammation

Interventions

Loteprednol Etabonateprednisolone acetate

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Binu Alexander, MD

    Valeant Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

September 21, 2011

Study Start

August 5, 2010

Primary Completion

October 19, 2015

Study Completion

October 19, 2015

Last Updated

November 19, 2019

Record last verified: 2019-11

Locations

KR(1)