Influence of Perfluorohexyloctane Eye Drops on Tear Film Thickness in Patients with Mild to Moderate Dry Eye Disease: A Randomized Controlled Clinical Trial

Schmidl, Doreen; Bata, Ahmed M.; Szegedi, Stephan; Santos, Valentin Aranha dos; Stegmann, Hannes; Fondi, Klemens; Krösser, Sonja; Werkmeister, René M.; Schmetterer, Leopold; Garhöfer, Gerhard

doi:10.1089/jop.2019.0092

Cited by 29 publications

(35 citation statements)

References 21 publications

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“…This has been observed in both healthy subjects as well as in patients with DED with different eye drops [ 25 , 28 , 29 , 30 ]. Whereas the effect of most lubricants on TFT is relatively short in time, ranging between several minutes and a few hours, some agents have been shown to increase TFT up to 24 h, such as topical chitosan-N-acetylcysteine, perfluorohexyloctane or low dose hydrocortisone [ 31 , 32 , 33 ].…”

Section: Imaging Modalitiesmentioning

confidence: 99%

“…While some studies report an immediate increase in LLT after instillation [ 93 , 94 , 95 , 96 ], other studies report no short-time effects of eye drops targeting the lipid layer of the tear film [ 28 ]. This could be due to technical limitations, because the natural lipid layer and the ingredients of the eye drops have different refractive indices, which affect the correct assessment of the LLT by interferometry [ 28 , 31 ]. Alternatively, the effect on the LLT may build up after multiple instillations [ 28 ].…”

Section: Imaging Modalitiesmentioning

confidence: 99%

“…Therefore, LLT may be used to monitor the effect of treatment on the lipid layer over time. Indeed some studies have observed an improvement of lipid layer thickness after a few weeks of instillation using lubricants as compared to placebo [ 31 , 97 ].…”

Section: Imaging Modalitiesmentioning

confidence: 99%

“…Values of less than 10 s are usually considered as DED when viewing the reflection of an illuminated grid pattern [ 112 ]. Therapy with topical lubricants improves NITFBUT in a similar fashion to TFBUT [ 31 , 115 ].…”

Section: Imaging Modalitiesmentioning

confidence: 99%

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Novel Approaches for Imaging-Based Diagnosis of Ocular Surface Disease

et al. 2020

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Imaging has become indispensable in the diagnosis and management of diseases in the posterior part of the eye. In recent years, imaging techniques for the anterior segment are also gaining importance and are nowadays routinely used in clinical practice. Ocular surface disease is often synonymous with dry eye disease, but also refers to other conditions of the ocular surface, such as Meibomian gland dysfunction or keratitis and conjunctivitis with different underlying causes, i.e., allergies or infections. Therefore, correct differential diagnosis and treatment of ocular surface diseases is crucial, for which imaging can be a helpful tool. A variety of imaging techniques have been introduced to study the ocular surface, such as anterior segment optical coherence tomography, in vivo confocal microscopy, or non-contact meibography. The present review provides an overview on how these techniques can be used in the diagnosis and management of ocular surface disease and compares them to clinical standard methods such as slit lamp examination or staining of the cornea or conjunctiva. Although being more cost-intensive in the short term, in the long term, the use of ocular imaging can lead to more individualized diagnoses and treatment decisions, which in turn are beneficial for affected patients as well as for the healthcare system. In addition, imaging is more objective and provides good documentation, leading to an improvement in patient follow-up and education.

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Section: Imaging Modalitiesmentioning

confidence: 99%

Section: Imaging Modalitiesmentioning

confidence: 99%

Section: Imaging Modalitiesmentioning

confidence: 99%

Section: Imaging Modalitiesmentioning

confidence: 99%

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Novel Approaches for Imaging-Based Diagnosis of Ocular Surface Disease

et al. 2020

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“…In all these trials, the outcome was the effect of eye drops on TFT. Five of the studies have already been published [24][25][26][27][28], data from one study is yet unpublished. As these studies include different interventions, for the current analysis only baseline data from both eyes were included.…”

Section: Patientsmentioning

confidence: 99%

The Association between Tear Film Thickness as Measured with OCT and Symptoms and Signs of Dry Eye Disease: A Pooled Analysis of 6 Clinical Trials

Garhöfer

Santos

Stegmann

et al. 2020

JCM

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Purpose: To determine the association between tear film thickness (TFT) as measured with ultra-high resolution optical coherence tomography (UHR-OCT) and signs and symptoms of dry eye disease (DED). Methods: A total of 450 eyes from 225 patients with DED from six different randomized clinical trials were included in this pooled analysis. In all subjects, TFT was measured with a custom-built UHR-OCT system. Symptoms of DED were quantified using a standardized Ocular Surface Disease Index (OSD)I questionnaire and clinical signs including tear film break up time (TFBUT) and Schirmer I test were assessed. Associations of the average TFT with OSDI, TFBUT, and Schirmer I test were calculated using a linear regression analysis. Results: The average TFT of the included sample (mean age, 45.0 ± 13.3 years; 65% female) was 4.2 ± 0.5 µm and the OSDI 36.2 ± 10.4. A significant negative correlation was found between TFT and OSDI (r = −0.36 to −0.31; p < 0.001). Tear break up time and Schirmer I test were not correlated with OSDI. Significant albeit weak correlations were found between TFT and TFBUT (r = 0.17 to 0.25; p < 0.01) as well as Schirmer I (r = 0.36 to 0.37; p < 0.001). Subgroup analysis revealed that the correlation was stronger in the subjects with abnormal Schirmer I (<15 mm; r = 0.50 to 0.54; p < 0.001). Conclusions: The present study demonstrates an objective measurement of TFT using a novel OCT approach for DED that correlates with symptoms and signs of DED. Our data are consistent with the idea that TFT represents the aqueous-deficient component of DED.

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Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients

et al. 2023

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ImportanceMeibomian gland dysfunction (MGD) is a leading cause of evaporative dry eye disease (DED). Medical and surgical management for DED is limited; therefore, new treatment options are sought.ObjectiveTo evaluate the efficacy and safety of SHR8058 (perfluorohexyloctane) eye drops in Chinese patients with DED associated with MGD through 57 days.Design, Setting, and ParticipantsThis was a randomized, multicenter, double-masked, saline-controlled, phase 3 clinical trial conducted from February 4, 2021, to September 7, 2022. Patients were recruited from the departments of ophthalmology in 15 hospitals in China. Patients with DED associated with MGD were enrolled between February 4 and July 1, 2021. The diagnosis was based on patient complaint of DED symptoms, an ocular surface disease index of 25 or higher, tear film break-up time of 5 seconds or less, Schirmer I test without anesthesia results of 5 mm or more at 5 minutes, total corneal fluorescein staining (tCFS) score of 4 to 11, and an MGD score of 3 or higher.InterventionsEligible participants were randomly assigned 1:1 to receive perfluorohexyloctane eye drops or 0.6% sodium chloride [NaCl]) 4 times per day.Main Outcomes and MeasuresThe primary end points were the changes from baseline in tCFS and eye dryness scores at day 57.ResultsA total of 312 participants were included in the analysis: 156 (mean [SD] age, 45.4 [15.2] years; 118 female [75.6%]) in the perfluorohexyloctane group and 156 (mean [SD] age, 43.7 [15.1] years; 127 female [81.4%]) in the NaCl group. Both primary end points were achieved, ie, changes from baseline at day 57 of tCFS score (mean [SD], −3.8 [2.7] vs −2.7 [2.8]) and eye dryness score (mean [SD], −38.6 [21.9] vs −28.3 [20.8]) in the perfluorohexyloctane group were superior to the control group, with estimated mean differences of −1.14 (95% CI, −1.70 to −0.57; P &lt; .001) and −12.74 (95% CI, −17.20 to −8.28, P &lt; .001), respectively. Improvements on both end points appeared to be noted on day 29 and day 15, respectively, and maintained through day 57. Compared with the control, perfluorohexyloctane eye drops also alleviated symptoms including pain (mean [SD] tCFS score, 26.7 [23.7] vs −18.7 [22.5]; P = .003), awareness of DED symptoms (mean [SD] tCFS score, −38.1 [25.1] vs −23.7 [27.6]; P &lt; .001), and frequency of dryness (mean [SD] tCFS score, −43.3 [23.8] vs −29.1 [24.8]; P &lt; .001). Treatment-emergent adverse events occurred in 34 participants (21.8%) and 40 participants (25.6%) in the perfluorohexyloctane and control groups, respectively.Conclusions and RelevanceResults of this randomized clinical trial demonstrate that perfluorohexyloctane eye drops significantly ameliorated the signs and symptoms of DED associated with MGD with a rapid efficacy as well as satisfactory tolerability and safety through 57 days. Findings support the use of these eye drops if results can be confirmed independently and over longer time periods.Trial RegistrationClinicalTrials.gov Identifier: NCT05515471

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Influence of Perfluorohexyloctane Eye Drops on Tear Film Thickness in Patients with Mild to Moderate Dry Eye Disease: A Randomized Controlled Clinical Trial

Cited by 29 publications

References 21 publications

Novel Approaches for Imaging-Based Diagnosis of Ocular Surface Disease

Novel Approaches for Imaging-Based Diagnosis of Ocular Surface Disease

The Association between Tear Film Thickness as Measured with OCT and Symptoms and Signs of Dry Eye Disease: A Pooled Analysis of 6 Clinical Trials

Perfluorohexyloctane Eye Drops for Dry Eye Disease Associated With Meibomian Gland Dysfunction in Chinese Patients

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