NCT01079858CompletedNot Applicable
Evaluation of FID 114657 in Dry Eye Subjects
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 49
- Primary Endpoint
- Preference based on subject's relief of dry eye
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •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.
Arms & Interventions
FID 114657 (ORB Preserved Ocular Emulsion)
Experimental
ORB Preserved Ocular Emulsion dosed as needed throughout the day (PRN)
Intervention: FID 114657 (ORB Preserved Ocular Emulsion) (Other)
Outcomes
Primary Outcomes
Preference based on subject's relief of dry eye
Time Frame: 5 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Not Applicable
Evaluation of Dry Eye and Meibomian Gland Dysfunction After Cataract SurgeryMeibomian Gland DysfunctionNCT01942642Yonsei University48
Completed
Not Applicable
iLux Treatment for Meibomian Gland Dysfunction (MGD)Evaporative Dry EyeNCT03055650Tear Film Innovations, Inc.30
Completed
Not Applicable
The Impact of Dry Eye Syndrome on Metrics of Low Contrast Vision Before and After Meibomian Gland ExpressionMeibomian Gland DysfunctionNCT05713981University of the Incarnate Word40
Completed
Not Applicable
Intense Pulsed Light in Meibomian Gland DysfunctionsMeibomian Gland DysfunctionDry Eye SyndromesNCT04147962Centre Hospitalier Universitaire de Saint Etienne45
Completed
Phase 1
IVIG-eye Drops Treatment for Dry Eye DiseaseDry EyeNCT03992482Sandeep Jain, MD27