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Evaluation of FID 114657 in Dry Eye Subjects

Primary Purpose

Meibomian Gland Dysfunction

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

FID 114657 (ORB Preserved Ocular Emulsion)

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Meibomian Gland Dysfunction, Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FID 114657 (ORB Preserved Ocular Emulsion)

Arm Description

ORB Preserved Ocular Emulsion dosed as needed throughout the day (PRN)

Outcomes

Primary Outcome Measures

Preference based on subject's relief of dry eye

Secondary Outcome Measures

Full Information

NCT ID

NCT01079858

First Posted

March 2, 2010

Last Updated

January 31, 2012

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01079858

Brief Title

Evaluation of FID 114657 in Dry Eye Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meibomian Gland Dysfunction

Keywords

Meibomian Gland Dysfunction, Dry Eye

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FID 114657 (ORB Preserved Ocular Emulsion)

Arm Type

Experimental

Arm Description

ORB Preserved Ocular Emulsion dosed as needed throughout the day (PRN)

Intervention Type

Other

Intervention Name(s)

FID 114657 (ORB Preserved Ocular Emulsion)

Intervention Description

Patients will dose as needed throughout the day (PRN) for 4 weeks.

Primary Outcome Measure Information:

Title

Preference based on subject's relief of dry eye

Time Frame

5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

12. IPD Sharing Statement

Learn more about this trial

Evaluation of FID 114657 in Dry Eye Subjects

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