Prospective Randomized Trial Comparing Efficacy of Topical Loteprednol Etabonate 0.5% Versus Cyclosporine-A 0.05% for Treatment of Dry Eye Syndrome Following Hematopoietic Stem Cell Transplantation

Boynton, Grace E.; Raoof, Duna; Niziol, Leslie M.; Hussain, Munira; Mian, Shahzad I.

doi:10.1097/ico.0000000000000436

Cited by 24 publications

(18 citation statements)

References 25 publications

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“…A possible explanation is that an ocular therapy had been administered to all those patients diagnosed as DE before HSCT, already before starting the conditioning regimen, and this could have tempered a DE progression after transplant. This hypothesis appears in agreement with others 44 who suggested the effectiveness of pre-HSCT initiation of therapy before HSCT for the treatment and prophylaxis of DE after HSCT.…”

Section: Eyesupporting

confidence: 92%

Ocular surface analysis in hematological patients before and after allogeneic hematopoietic stem cell transplantation: implication for daily clinical practice

Giannaccare

Bonifazi

Sessa

et al. 2017

Eye

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PurposeTo evaluate ocular surface parameters before and after hematopoietic stem cell transplantation (HSCT) and to correlate them with clinical and transplant variables.MethodsThis is a retrospective analysis of data from 93 patients affected by hematological malignancies undergoing HSCT. Values from Ocular Surface Disease Index, Schirmer test, Break-up Time, ocular surface staining, and Meibomian Gland Dysfunction score obtained before HSCT and 3-6 months after were retrieved from charts. Diagnosis and staging of dry eye (DE) disease was performed according to Dry Eye WorkShop criteria. Graft-versus-host-disease (GVHD) was classified according to the NIH criteria. Odds ratios for DE onset after HSCT were estimated for demographic, ocular, hematological and transplant variables.ResultsDE was diagnosed before HSCT in 50 (53%) of the patients, mostly of hyperevaporative profile. After HSCT, all ocular parameters significantly worsened with no change in DE profile. A 51% incident cases (22 of the 43 non-DE subjects) were reported. Increasing recipient age and female sex, higher CD34+ cells infused, donor-recipient sex mismatch (males receiving from females), related donors, and peripheral blood cells as stem cell source were associated with a significant higher incidence of DE after HSCT. Systemic chronic GVHD was diagnosed in 42% while ocular GVHD in 35.5% of the patients, which decreased to 12% when taking into account only incident cases.ConclusionsHigh DE prevalence was shown already before HSCT. A pre-HSCT ocular surface assessment is recommended for early DE diagnosis and treatment. This new protocol also influences the prevalence of ocular GVHD.

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Section: Eyesupporting

confidence: 92%

Ocular surface analysis in hematological patients before and after allogeneic hematopoietic stem cell transplantation: implication for daily clinical practice

Giannaccare

Bonifazi

Sessa

et al. 2017

Eye

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“…The early start of treatment with topical CsA is critical and has been used as a standard option aimed to preserve a functional eye, though most patients begin receiving treatment after permanent damage to ocular tissues has already occurred [20]. Treatment with immunosuppressants may not always be effective for dry eye, among other oGVHD symptoms, especially after they are severe [28,29]. Damage to the lacrimal gland and corneal epithelium caused by reactive lymphocytes begins once successful grafting is achieved, i.e., 15-20 days after the infusion of hematopoietic stem cells and much earlier than the onset of clinical manifestations.…”

Section: Discussionmentioning

confidence: 99%

Cyclosporine A for the Prevention of Ocular Graft versus Host Disease in Allogeneic Hematopoietic Stem Cell Transplant Recipients Is Safe and Feasible

et al. 2019

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To evaluate the safety and efficacy of ocular cyclosporine in the prevention of the development of ocular graft versus host disease (oGVHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (AHSCT) in comparison with historic data. Design: We developed a longitudinal, observational, prospective nonrandomized study. We evaluated the feasibility of prophylactic use of topical cyclosporine A (CsA) to prevent or decrease the incidence of oGVHD and compared this with historic data. Methods: Patients undergoing AHSCT were treated with prophylactic topical CsA for 12 months after engraftment, followed by serial ophthalmic evaluations, including the Schirmer test. Results: Twenty patients were included. No serious adverse effects were reported. Poor adherence was documented in 15% of patients. In spite of observing extra-ocular GVHD (acute and chronic GVHD incidence of 50 and 45%, respectively), only 1 in 20 patients developed oGVHD over the 20-month follow-up for the entire cohort. No statistically significant difference was observed in the incidence of oGVHD when compared to a historical cohort. Conclusions: Topical CsA as a prophylactic measure for oGVHD, administered over a period of 1 year after grafting, is safe and feasible and may decrease the incidence of ophthalmic manifestations of GVHD. These findings must be confirmed in a randomized trial.

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“…LE has been studied as a treatment for a variety of dry eye disorders [34][35][36], as well as induction therapy to reduce stinging associated with topical cyclosporine therapy for dry eye disease [37,38]. A 1-month randomized, double-masked, vehicle-controlled pilot study assessed the efficacy of LE suspension 0.5% QID in patients with dry eyes related to delayed tear clearance [34].…”

Section: Dry Eye Disordersmentioning

confidence: 99%

“…A prospective, randomized trial compared LE with topical cyclosporine 0.5% emulsion (tCSA) to prevent and treat graft versus host disease-related dry eye syndrome (DES) in patients undergoing hematopoietic stem cell transplant [36]. Patients were randomized to LE 0.5% BID or tCSA 0.05% BID starting 1 month before transplantation.…”

Section: Dry Eye Disordersmentioning

confidence: 99%

Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid

Comstock¹,

Sheppard

2018

Expert Opinion on Pharmacotherapy

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Topical corticosteroids are an important pharmacotherapy for the management of various inflammatory conditions affecting the anterior segment of the eye. However, medications in this class are associated with well-known risks including increased intraocular pressure (IOP) and development of cataracts. The topical corticosteroid loteprednol etabonate (LE) was developed with the specific intention of minimizing these side effects. Areas covered: The focus of this review is to examine published efficacy and safety data for LE, a drug engineered to undergo rapid metabolism to inactive metabolites with the goal of improved safety. Two decades of clinical research focused on LE formulations are reviewed, including the use of LE in combination with tobramycin. The cumulative body of experience affirms the concept that the molecular design of LE confers certain safety benefits without compromising the desired anti-inflammatory efficacy of a topical corticosteroid. Expert opinion: Loteprednol etabonate is a mainstay for topical therapy of a wide variety of commonplace and niche conditions of the ocular surface and the anterior segment, including in the healing post-operative patient. Its versatility and safety allow eye care providers to recommend both acute induction as well as chronic maintenance therapy with appropriate follow-up.

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Prospective Randomized Trial Comparing Efficacy of Topical Loteprednol Etabonate 0.5% Versus Cyclosporine-A 0.05% for Treatment of Dry Eye Syndrome Following Hematopoietic Stem Cell Transplantation

Abstract: Pre-HSCT initiation of LE 0.5% appears to be safe and may be as effective as CsA 0.5% for the treatment and prophylaxis of DES following HSCT.

Cited by 24 publications

References 25 publications

Ocular surface analysis in hematological patients before and after allogeneic hematopoietic stem cell transplantation: implication for daily clinical practice

Ocular surface analysis in hematological patients before and after allogeneic hematopoietic stem cell transplantation: implication for daily clinical practice

Cyclosporine A for the Prevention of Ocular Graft versus Host Disease in Allogeneic Hematopoietic Stem Cell Transplant Recipients Is Safe and Feasible

Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid

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