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A Study to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01437982
First received: September 20, 2011
Last updated: February 8, 2017
Last verified: February 2017
  Purpose
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice

Condition Intervention Phase
Conjunctivitis, Seasonal Allergic
Conjunctivitis, Giant Papillary
Inflammation
Drug: Loteprednol Etabonate
Drug: Prednisolone Acetate 1% Oph Susp
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
Official Title: A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Lotemax Ophthalmic Suspension 0.5%

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Safety [ Time Frame: 4 years ]
    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.


Secondary Outcome Measures:
  • Seasonal Allergic Conjunctivitis [ Time Frame: 4 years ]
    Signs and symptoms of seasonal allergic conjunctivitis: The efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.

  • Giant Papillary Conjunctivitis [ Time Frame: 4 years ]
    Signs and symptoms of giant papillary conjunctivitis: The results of the efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.

  • Post-operative inflammation [ Time Frame: 4 years ]
    Treatment of post-operative inflammation following ocular surgery: The results of the final efficacy assessment will be evaluated according to the classification: improved, unchanged, worsened, impossible to assess.


Estimated Enrollment: 140
Actual Study Start Date: February 2013
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Loteprednol Etabonate
Ophthalmic Gel 0.5%
Drug: Loteprednol Etabonate
Ocular administration of study drug. at least once within any indication of the label.
Other Name: Lotemax
Experimental: Prednisolone Acetate 1% Oph Susp
Ophthalmic suspension 0.5%
Drug: Prednisolone Acetate 1% Oph Susp
Ocular administration of study drug. at least once within any indication of the label.
Other Name: Prednisolone Acetate

Detailed Description:
The objective of this study is to identify any adverse events or adverse drug reactions through post-marketing surveillance under routine clinical practice after marketing authorization of Lotemax ophthalmic suspension 0.5%
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects not treated with study drug at least once.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437982

Locations
Korea, Republic of
Bausch & Lomb Korea Ltd
Seoul, Korea, Republic of, 135-280
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Binu Alexander, MD Valeant Pharmaceuticals
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01437982     History of Changes
Other Study ID Numbers: 628 
Study First Received: September 20, 2011
Last Updated: February 8, 2017

Keywords provided by Bausch & Lomb Incorporated:
post-operative inflammation
conjunctivitis
safety
Seasonal allergic conjunctivitis
Giant papillary conjunctivitis

Additional relevant MeSH terms:
Inflammation
Conjunctivitis
Conjunctivitis, Allergic
Pathologic Processes
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol Etabonate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 17, 2017