TFOS DEWS II Clinical Trial Design Report

Novack, Gary D.; Asbell, Penny A.; Barabino, Stefano; Bergamini, Michael V.W.; Ciolino, Joseph B.; Foulks, Gary N.; Goldstein, Michael H.; Lemp, Michael A.; Schrader, Stefan; Woods, Craig A.; Stapleton, Fiona

doi:10.1016/j.jtos.2017.05.009

Cited by 91 publications

(72 citation statements)

References 198 publications

(260 reference statements)

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“…Corneal and conjunctival fluorescein staining marks the compromised integrity of tight junctions or the glycocalyx of viable ocular cells, whereas conjunctival redness indicates vascular dilatation as a sign of inflammation (Wolffsohn et al 2017). The SIME regimen decreased these objective parameters significantly after 30 dayswith no marked changes yet at 10 dayscorroborating the fact that tissue damage and inflammatory activity are late-stage markers (Novack et al 2017) which follow changes in tear film stability and osmolarity. It is possible that natural antioxidants, especially high concentration of c-tocopherol in sacha inchi seed oil (Chirinos et al 2015;Wang et al 2018), provided cytoprotective and wound-healing activity by attenuating hyperosmolarity-associated oxidative stress.…”

Section: Discussionmentioning

confidence: 97%

“…A lipid component may prolong the retention of eye drops on the ocular surface (Ma€ ıssa et al 2010) and provide a prophylactic effect against aggravation of symptoms in certain environmental conditions (Gokul et al 2018). Improvement in dry eye symptoms has direct consequences in the quality of life of patients typically complaining of problems with visual function, such as glare and blurred or fogged vision (Novack et al 2017). A clear difference should be made between dry eye-related and eye drop-induced blurring of vision; the former is a chronic trouble and a part of functional symptom questionnaires (such as OSDI question number 4), whereas the latter is an immediate and transient consequence of instilling liquid on the ocular surface.…”

Section: Discussionmentioning

confidence: 99%

“…Based on total evidence, the effect of SIME was consistently larger on all signs (Table 2), suggesting nonequivalence of interventions. A planned limitation was the comparison between contralateral eyes in Part 2, successfully used in dry eye studies (Larmo et al 2018 and references therein), although potentially subject to intereye signalling (Novack et al 2017); both eye drops contain 0.2% HA and showed all effects to the same direction, diminishing the likelihood of a blocking effect in the fellow eye. The safety results of Part 2 were also necessary to proceed to Part 3.…”

Section: Discussionmentioning

confidence: 99%

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Disease aetiology‐based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple‐masked and active‐controlled clinical trial

Laihia¹,

Järvinen²,

Wylęgała

2019

Acta Ophthalmologica

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Purpose: To assess the safety and efficacy of multi-ingredient sacha inchi microemulsion (SIME) eye drops designed to target (1) tear film instability, (2) tear hyperosmolarity, and (3) ocular surface damage and inflammation in moderate or severe dry eye. Methods: This randomized, quadruple-masked, active-controlled parallel study in 64 adult patients comprised three parts. Part 1 (n = 3): one eye was treated with SIME for one day. Part 2 (n = 9): randomized eyes were treated with SIME and 0.2% hyaluronic acid (HA) control eye drops 3 times a day for 10 days. Part 3 (n = 26 + 26): randomized treatment was applied on both eyes 3 times a day for 30 days. OSDI change was tested for superiority of SIME over HA. Ocular assessments were performed at baseline and after the last dose. Results: Both treatments were well tolerated without adverse device effects. Tear film break-up time (p = 0.0025) and ocular protection index (p = 0.0026; change vs. HA, p = 0.047) increased significantly with SIME after 30 days. Tear osmolarity decreased more in SIME than in the HA group and significantly with both eye drops in hyperosmolar subgroups. Corneal (p = 0.014) and nasal conjunctival staining (p = 0.043) were reduced with SIME in per-protocol patients (n = 24). Conjunctival (p = 0.001) and lid redness (p = 0.012) decreased with SIME in all patients (n = 26). Symptoms decreased by about 25 OSDI units with both treatments (p < 0.0001) and with nonsignificant difference between treatments. Conclusions: Sacha inchi microemulsion (SIME) proved safe and efficacious in improving each aetiologic factor for dry eye as revealed through objective tests. Hyperosmolar stress dominating blink cycles must be disrupted by biophysical protection of the ocular surface to facilitate resolution of cellular damage and inflammation, and relief of ocular symptoms.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Disease aetiology‐based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple‐masked and active‐controlled clinical trial

Laihia¹,

Järvinen²,

Wylęgała

2019

Acta Ophthalmologica

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“…Recommendations for the clinical trial design of DE have been given by the TFOS DEWS Clinical Trial Subcommittee. [ 44 ] This means more high-quality clinical studies will be published. Therefore, we proposed this systematic review aims to provide reliable evidence for the effectiveness and safety of AC therapy for DE.…”

Section: Discussionmentioning

confidence: 99%

Acupuncture for the treatment of dry eye

et al. 2020

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Background: As a common ophthalmic disease, dry eye (DE) may bring several adverse effects on the quality of life for patients. In recent years, Acupuncture (AC) is becoming increasingly popular for treating DE. Thus, we conceived this systematic review aims to evaluate the effectiveness and safety of AC for DE objectively. Methods: The search results are restricted to randomized controlled trials and human studies. We will establish the inclusion criteria through discussion and design a detailed literature search strategy for each database. Articles are searched from 4 English databases (the Cochrane Library, PubMed, Web of Science, and EMBASE) and 4 Chinese databases (Wangfang, China National Knowledge Infrastructure, Chinese Biomedical Literature Database, and Chinese scientific and technical journals database). The relevant studies published from the date of database inception until January 2020 will be collected. We will also search (International Clinical Trials Registry Platform), PROSPERO, and potential gray literature. Two reviewers independently perform literature screening, information extraction, and assessment of study quality. The outcome measures include primary outcome measures (Schirmer I test and break-up time), secondary outcome measures (Ocular Surface Disease Index, corneal fluorescein staining, and tear osmolarity), and safety outcome measures. Assessment of bias risk and data processing are performed using RevMan 5.3 software ( the Nordic Cochrane Centre, Copenhagen, Denmark). Results: We will evaluate the curative effect of AC for DE comprehensively based on multiple outcome measures. Conclusion: This systematic review will provide evidence for the effectiveness and safety of AC in the treatment of DE. PROSPERO number: CRD42019144790

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“…It was expected that the participants' knowledge of getting active treatments (placebo effect) would be similar for the SB and reference sprays. It must also be acknowledged that the effects of different treatments observed in the contralateral eyes are not fully independent because of inter-eye signalling [45]. This may have equalized the differences in OSDI, especially at the end of part three, where the untreated eye showed only mild symptoms.…”

Section: Discussionmentioning

confidence: 99%

Effects of a sea buckthorn oil spray emulsion on dry eye

Larmo¹,

Järvinen²,

Laihia³

et al. 2019

Contact Lens and Anterior Eye

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To investigate the effects of a sea buckthorn oil and sodium hyaluronate-containing eyelid spray emulsion (SB spray) on dry eye. Methods: A randomized controlled study was carried out. Adults (25-70 years) with Ocular Surface Disease Index (OSDI) ≥20 and moderate or severe dryness, burning or grittiness of the eyes were included. In study part one (n = 2), SB spray was used on both closed eyelids four times in one day. In part two (n = 10), SB spray was used on one randomized eyelid, and a commercial reference spray on the other for nine days. In part three (n = 40), eyes were randomized to one eye receiving SB spray and an untreated control for 1.5 months. Dry eye tests were carried out at baseline, during, and at the end of each study section. Symptoms were recorded in questionnaires and daily logs. Results: In part one, the SB spray was well tolerated. In part two, OSDI decreased significantly (P = 0.022) in the SB spray eye compared to the reference spray, indicating a beneficial effect on symptoms. In part three, OSDI in the SB spray eye decreased significantly compared to the untreated control (P = 0.0007). The scores for dryness at the study end were lower in the SB spray eye compared to control (P = 0.0070). Symptom sums and frequencies of dryness (sum P = 0.0046, frequency P = 0.0016) and watering (sum P = 0.0003, frequency P = 0.013) in the daily logs were lower in the eye treated with SB spray. Conclusions: SB spray on closed eyelids relieved the symptoms of dry eye. substantiated risk factors include aging, female sex, Asian ethnicity, Sjögren's syndrome, connective tissue diseases, and meibomian gland dysfunction, along with several modifiable factors (e.g. computer use, low environmental humidity, and certain medications) [4]. Dry eye can cause significant pain and limit everyday activities such as reading and using a computer [4]. The condition is commonly treated with artificial tears in an attempt to supplement the tear film. Lipid-containing products are considered a good alternative to traditional water-based formulations because they more closely resemble the composition of the tear film. During recent years, artificial tears sprayed on closed eyelids have been introduced as alternatives to eye drops [5,6]. The effects of oral sea buckthorn oil on dry eye have previously been investigated. Intake of 2 g sea buckthorn oil taken as four capsules per day for three months improved tear osmolarity and symptoms compared to placebo in a randomized, double-blind, placebo-controlled trial [7]. In the current study sea buckthorn oil was

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TFOS DEWS II Clinical Trial Design Report

Cited by 91 publications

References 198 publications

Disease aetiology‐based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple‐masked and active‐controlled clinical trial

Disease aetiology‐based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple‐masked and active‐controlled clinical trial

Acupuncture for the treatment of dry eye

Effects of a sea buckthorn oil spray emulsion on dry eye

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