Evaluation of FID 114657 in Dry Eye Subjects

January 31, 2012 updated by: Alcon Research
The primary objective of this study is to assess the overall Meibomian Gland Dysfunction Subject's preference for a particular product. Dry eye symptom relief will also be evaluated based on clinical evaluation and a set of subject questionnaires.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be at least 18 years of age
  • must read and sign the informed consent forms (ICF)
  • must agree to comply with the study requirements.
  • Patients must have a best corrected visual acuity of 0.6 LogMar or better in each eye
  • must report having an ocular examination in the last two years
  • must be using topical ocular dry eye therapy (artificial tears or Restasis® at least 2 times per day.
  • must have been diagnosed with Meibomian Gland Dysfunction / Posterior Blepharitis based on the following criteria: must have dry eye symptoms and Meibomian gland expression grade greater than 1.

Exclusion Criteria:

  • Patients cannot wear contact lenses during the study and cannot have a history of hypersensitivity to any component of FID 114657.
  • Patients cannot have ocular or intraocular surgery or serious ocular trauma within the past 6 months, and cannot have a history and/or current evidence of active intraocular inflammation in either eye.
  • Patients cannot have punctal plugs that were placed less than or equal to 30 days prior to Visit 1, and they cannot have ocular conditions that, in the opinion of the investigator, preclude the safe administration of the test article.
  • They cannot have started or changed the dose of chronic systemic medication within 7 days prior to visit 1, and must remain on a stable dosing regimen for the duration of the study.
  • Patients cannot have participated in another investigational clinical or research study within 30 days of visit 1.
  • Subjects cannot have a history and/or current evidence of the following: epithelial herpes simplex keratitis (dendritic keratitis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; active ocular rosacea (excluding subjects enrolled with MGD (posterior blepharitis)); acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal diseases of the eye.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FID 114657 (ORB Preserved Ocular Emulsion)
ORB Preserved Ocular Emulsion dosed as needed throughout the day (PRN)
Other: FID 114657 (ORB Preserved Ocular Emulsion)
Patients will dose as needed throughout the day (PRN) for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Preference based on subject's relief of dry eye
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

January 31, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMA-09-61

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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