Clinical trial NCT05594745: Treatment Regimens in Meibomian Gland Dysfunction
Official title: Comparative Efficacy of Different Treatment Regimens in Patients With Dry Eye Disease and Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Tauber Eye Center
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple group, single unmasked randomized trial
Primary purpose: TREATMENT

Brief summary: This study seeks to explore the relevance of inflammation in dry eye patients with MGD and compare the efficacy of LipiFlow treatment followed by lid hygiene and lubricant treatment with Systane Ultra or LipiFlow treatment followed by lid hygiene and lifitegrast treatment in patients with meibomian gland dysfunction.

Detailed description: The role of inflammation as a central mechanism of pathophysiology in dry eye disease has been well documented, including both clinical and basic science studies. It has been estimated that 50-75% of patients complaining of dry eyes have meibomian gland dysfunction (MGD). As defined by TFOS DEWs II MGD is a chronic, diffuse abnormality of the meibomian glands, commonly characterized by terminal duct obstruction and/or qualitative/quantitative changes in the glandular secretion. This may result in the alteration of the tear film, symptoms of eye irritation, clinically apparent inflammation, and ocular surface disease. It has been estimated that 86% of patients complaining of dry eye disease demonstrate meibomian gland dysfunction. The role of ocular surface inflammation vs. the role of obstructive meibomian gland disease is less well understood.

The symptoms of MGD (evaporative dry eye) may be difficult to differentiate from those of dry eye syndrome (aqueous deficient dry eye (ADDE)), though MGD patients tend to report more burning and stinging than they report complaints of grittiness, sandiness or foreign body sensation in the eyes. However, there is a significant lack of association between signs and symptoms in patients with dry eye disease, which makes it extremely difficult to sort out which patients would benefit from which treatment options. Given the high prevalence of dry eye in the general population any attempt to segregate patients into appropriate treatment types is important.

Traditional treatment options for MGD include the use of artificial lubricants (some lipid-containing such as Systane Ultra), warm lid compresses using cloths or heat pads of various materials, systemic tetracyclines and episodic treatment with topical antibiotics or antibiotic/steroid combinations. Eyelid thermal pulsation procedures (e.g. LipiFlow) have helped many patients. Only one published study supports the benefit of anti-inflammatory treatment (lifitegrast) in patients with MGD. This study seeks to explore the relevance of inflammation in dry eye patients with MGD and compare the efficacy of LipiFlow treatment followed by lid hygiene and lubricant treatment with Systane Ultra or LipiFlow treatment followed by lid hygiene and lifitegrast treatment in patients with meibomian gland dysfunction.

Eligibility criteria: Inclusion Criteria:

1. Adult patients aged 18 or older, of any sex and any race. 2. Clinical diagnosis of MGD, defined as:

1. complaints of burning, stinging or dryness \> 40 on scale of 0-100.
2. thickened secretions or occlusion of \> 4 of eight assessed glands of the central lower eyelid.
3. clinically evident redness of the eyelid margin \> 1+ on a scale of 0-4. 4. Willing to comply with the protocol instructions. 5. Has read (or has had read to), understood, and signed an Informed Consent.

   -

   Exclusion Criteria:
   * 1. Active ocular infection or ocular inflammatory disease. 2. Anterior basement membrane dystrophy or history of recurrent erosion syndrome.

     3. History of severe / serious ocular pathology or other medical condition that could result in an inability to safely complete the study. 4. Ocular surgery, LipiFlow or iLux or IPL or MG duct probing within past 6 months.

     5. Participation by the patient in any other investigational study within the past 30 days.

     6. Unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.).

   The Principal Investigator or the Medical Monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.

Primary outcomes:
measure: eye dryness score
timeFrame: 9 months
Secondary outcomes:
measure: corneal flurescein staining
timeFrame: 9 months
measure: ocular discomfort score
timeFrame: 9 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: joseph Tauber
state: Missouri
Study officials:
References:
citation: Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.
citation: Nichols KK, Nichols JJ, Mitchell GL. The lack of association between signs and symptoms in patients with dry eye disease. Cornea. 2004 Nov;23(8):762-70. doi: 10.1097/01.ico.0000133997.07144.9e.
citation: Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.
citation: Starr CE, Gupta PK, Farid M, Beckman KA, Chan CC, Yeu E, Gomes JAP, Ayers BD, Berdahl JP, Holland EJ, Kim T, Mah FS; ASCRS Cornea Clinical Committee. An algorithm for the preoperative diagnosis and treatment of ocular surface disorders. J Cataract Refract Surg. 2019 May;45(5):669-684. doi: 10.1016/j.jcrs.2019.03.023.