Evaluation of FID 114657 in Dry Eye Subjects

Meibomian Gland Dysfunction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079858
• Other study ID #: SMA-09-61
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: January 31, 2012
• Start date: February 2010

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Other:
• FID 114657 (ORB Preserved Ocular Emulsion)
Patients will dose as needed throughout the day (PRN) for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preference based on subject's relief of dry eye		5 weeks	No