A Practical Approach to Severity Classification and Treatment of Dry Eye Disease: A Proposal from the Mexican Dry Eye Disease Expert Panel

Rodríguez-García, Alejandro; Babayán-Sosa, Alejandro; Ramírez-Miranda, Arturo; Cruz-Valdes, Concepcion Santa; Hernández-Quíntela, Everardo; Hernández-Camarena, Julio C.; Ramos-Betancourt, Nallely; Velasco-Ramos, Regina; Ruiz-Lozano, Raúl E.

doi:10.2147/opth.s351898

Cited by 7 publications

(5 citation statements)

References 160 publications

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Section: Discussionmentioning

confidence: 99%

“…The restoration of the parameters affected by DED was defined by the reduction of the OSDI score back to normal values (<13), the improvement of TBUT ≥10 seconds, and/or the presence of no epithelial staining (grade 0) after a one-month treatment period in at least one group. 1,2,16 The OSDI questionnaire is the most widely used test in DED clinical trials. It measures frequency of symptoms in several environmental settings and vision-related quality of life.…”

Section: Discussionmentioning

confidence: 99%

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The Effect of Sodium Hyaluronate Eye Drops 2, 4 or 6 Times a Day on Signs and Symptoms of Dry Eye Disease

Muñoz-Villegas,

Sánchez-Ríos,

Olvera-Montaño

2023

OPTH

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Purpose A randomized clinical trial was run to evaluate the effectiveness of a preservative-free 0.4% sodium hyaluronate eye drop (LOF) in different dosage schemes to alleviate signs and symptoms of dry eye disease (DED). Methods A total of 116 subjects with mild-to-moderate DED were included, and 111 completed the study (from which 67.6% were female and 65.3% were users of oral contraceptives). Patients were randomly assigned to instill a drop of LOF either 2 (BID), 4 (QID) or 6 (6TD) times a day (at least 3 hours apart) for 30 days. The clinical parameters and symptom endpoints were Ocular Surface Disease Index (OSDI), tear break-up time (TBUT), ocular surface staining, and conjunctival hyperemia. Other parameters evaluated were chemosis, best corrected visual acuity, and the incidence of adverse events (AE). Results There was a significant reduction in OSDI scores by day 30 in all groups. The recovery of the OSDI score back to normal values was observed in 51.4% of patients treated (50%, 48.6%, and 55.6% in BID, QID, and 6TD, respectively, p = 0.822). Similar improvement was observed for TBUT, 50.5% of patients increased this variable to >10 seconds (39.5%, 51.4%, and 61.1%, p = 0.175), and for ocular surface staining, ≥72% showed Grade 0. There were no significant differences among posology groups regarding ocular surface staining, conjunctival hyperemia, or any safety parameters. No overall improvement in OSDI and TBUT to normal values was noted for 31 patients (21 were female and 71.4% users of contraceptive drugs). Conclusion The ophthalmic use of preservative free LOF, 2, 4 or 6 times a day, may alleviate clinical parameters and symptoms in 50% of patients with mild-to-moderate DED after a one-month treatment. This improvement seemed to be less ubiquitous in patients within reproductive age and using oral contraceptives. Trial Registration This trial is registered at clinicaltrials.gov (NCT0704531).

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The Effect of Sodium Hyaluronate Eye Drops 2, 4 or 6 Times a Day on Signs and Symptoms of Dry Eye Disease

Muñoz-Villegas,

Sánchez-Ríos,

Olvera-Montaño

2023

OPTH

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“…DED was defined as patients presenting with an OSDI score of ≥13 along with at least one homeostasis marker, as defined by the DEWS-II diagnostic approach [ 78 ]. Patients were categorized as having mild-to-moderate DED, corresponding to Grades I and II of the Tear Film and Ocular Surface Society (TFOS) DEWS I severity classification [ 79 ]. To be included in the study, patients had to test positive for the presence of MMP-9 with an InflammaDry© (Quidel Eye Health, San Diego, CA, USA) test result exceeding 40 ng/mL.…”

Section: Methodsmentioning

confidence: 99%

Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin

Ng,

Altamirano-Vallejo,

Navarro-Partida

et al. 2024

Pharmaceuticals

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The aim of this work was to assess the tolerability, safety, and efficacy of an ophthalmic topical formulation containing helenalin from Arnica montana and hyaluronic acid 0.4% (HA) in patients with mild-to-moderate Dry Eye Disease (DED) exhibiting positive Matrix Metalloproteinase 9 (MMP-9) test results. Tolerability and safety were evaluated in 24 healthy subjects. Participants were instructed to apply one drop of the formulation three times a day in the study eye, for 2 weeks, followed by a clinical follow-up of 21 days. Efficacy was studied in 48 DED patients randomized into Study (Group 1/receiving the studied formulation) or Control (Group 2/Receiving HA 0.4% eye lubricant) groups for 1 month. Assessments included an MMP-9 positivity test, conjunctival impression cytology (CIC), Ocular Surface Disease Index (OSDI), non-invasive film tear breakup time (NIBUT), non-invasive average breakup time (NIAvg-BUT), ocular surface staining, Schirmer’s test, and meibomiography. A crossover design with an additional 1-month follow-up was applied to both groups. Healthy subjects receiving the studied formulation exhibited good tolerability and no adverse events. Regarding the efficacy study, Group 1 exhibited a statistically significant reduction in the MMP-9 positivity rate compared to Group 2 (p < 0.001). Both Group 1 and Group 2 exhibited substantial improvements in OSDI and NIBUT scores (p < 0.001). However, Group 1 demonstrated a significant improvement in NI-Avg-BUT and Schirmer’s test scores (p < 0.001), whereas Group 2 did not (p > 0.05). Finally, after the crossover, the proportion of MMP-9-positive subjects in Group 1 increased from 25% to 91.6%, while Group 2 showed a significant decrease from 87.5% to 20.8%. Overall, the topical formulation containing sesquiterpene helenalin from Arnica montana and hyaluronic acid was well tolerated and exhibited a favorable safety profile. Our formulation reduces DED symptomatology and modulates the ocular surface inflammatory process; this is evidenced by the enhancement of CIC, the improvement of DED-related tear film status, and the reduction of the MMP-9 positivity rate.

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“…In this regard, PLMs for the management of OHT and glaucoma have been shown to cause damage to the LFU through a myriad of mechanisms, including a decrease in conjunctival goblet cell (GC) density, squamous metaplasia (Baudouin et al, 2008), conjunctival human leukocyte antigen (HLA)-DR overexpression (Baudouin et al, 2008), and disruption of the degrading-remodeling effect between MMPs and tissue inhibitors of metalloproteinases (TIMPs) in the ECM compounds, including collagen fibers (Karli et al, 2018). Moreover, the need for fixed combinations, commonly required by patients exhibiting disease progression and lifelong treatment, as well as the vehicles and preservatives contained in drug formulations [i.e., benzalkonium chloride (BAK)], will result in a significant number of patients experiencing ocular surface damage (Tiedemann et al, 2019;Rodriguez-Garcia et al, 2022). Additionally, an impression cytology study reported significant overexpression of C-C chemokine receptors (CCR)-type 4 and 5 in the conjunctival epithelium of glaucoma subjects chronically treated with PLMs compared with controls (Baudouin et al, 2008).…”

Section: Nitric Oxide (No)-donating Prostaglandin Analogs (Pgas)mentioning

confidence: 99%

“…Patients with prior DED, those exposed to preserved pressure-lowering medications (PLMs), and those requiring ≥1 agent (Saade et al, 2015), are at an increased risk of experiencing worse OSD symptoms. Furthermore, dry eye symptoms can result in increased patient depression, anxiety, and poor quality of life (QoL), which, in turn, is associated with poor compliance to glaucoma therapy and an increased risk of glaucoma progression (Stringham et al, 2018;Tirpack et al, 2019;Rodriguez-Garcia et al, 2022). Thus, addressing OSD in patients with glaucoma is necessary.…”

Section: Introductionmentioning

confidence: 99%

Ocular surface disease: a known yet overlooked side effect of topical glaucoma therapy

et al. 2023

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Ocular surface disease (OSD), a disorder affecting the lacrimal and meibomian glands and the corneal and conjunctival epithelium, is a well-known complication of topical glaucoma therapy. OSD can present as a new or pre-existing condition that virtually any anti-glaucoma formulation can exacerbate. As such, both glaucoma and OSD frequently coexist. Typical OSD symptoms include ocular discomfort, redness, burning, and dryness, whereas signs include periorbital and eyelid skin pigmentation, conjunctival scarring, and superficial punctate keratitis. Pressure-lowering eyedrops can cause toxic, allergic, and inflammatory reactions on the ocular surface. The latter can result from either preservatives or direct toxicity from the active molecule. Although usually mild, OSD can cause significant symptoms that lead to poor quality of life, decreased compliance to therapy, glaucoma progression, and worse visual outcomes. Given the chronic nature of glaucoma, lack of curative therapy, and subsequent lifelong treatment, addressing OSD is necessary. This manuscript aims to provide an up-to-date overview of OSD’s signs, symptoms, and pathogenic mechanisms from glaucoma therapy toxicity.

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A Practical Approach to Severity Classification and Treatment of Dry Eye Disease: A Proposal from the Mexican Dry Eye Disease Expert Panel

Cited by 7 publications

References 160 publications

The Effect of Sodium Hyaluronate Eye Drops 2, 4 or 6 Times a Day on Signs and Symptoms of Dry Eye Disease

The Effect of Sodium Hyaluronate Eye Drops 2, 4 or 6 Times a Day on Signs and Symptoms of Dry Eye Disease

Enhancing Ocular Surface in Dry Eye Disease Patients: A Clinical Evaluation of a Topical Formulation Containing Sesquiterpene Lactone Helenalin

Ocular surface disease: a known yet overlooked side effect of topical glaucoma therapy

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