Evaluation of FID 114657 in Dry Eye Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01079858
First received: March 2, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Meibomian Gland Dysfunction
Other: FID 114657 (ORB Preserved Ocular Emulsion)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Preference based on subject's relief of dry eye [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: February 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01079858     History of Changes
Other Study ID Numbers: SMA-09-61
Study First Received: March 2, 2010
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Alcon Research:
Meibomian Gland Dysfunction
Dry Eye

ClinicalTrials.gov processed this record on October 23, 2014