Semi-fluorinated Alkane Eye Drops Reduce Signs and Symptoms of Evaporative Dry Eye Disease After Cataract Surgery

Son, Hyeck-Soo; Yildirim, Timur M.; Khoramnia, Ramin; Poompokawat, Piyanut; Knorz, Michael C.

doi:10.3928/1081597x-20200519-01

Cited by 9 publications

(10 citation statements)

References 40 publications

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confidence: 99%

“…9 Recently, perfluorohexyloctane was also evaluated as ocular surface treatment after cataract surgery in patients with evaporative dry eye disease, suggesting its suitability in postoperative management. 15 This report presents the results of the SEECASE study evaluating the efficacy and safety of NOV03 ophthalmic solution compared with saline ophthalmic solution in the treatment of DED associated with MGD. The primary goal of the development program, however, is a DED indication.…”

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confidence: 99%

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A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease

Tauber

Wirta²,

Sall

et al. 2020

Cornea

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Purpose: NOV03 has a unique dual mode of action to address dry eye disease (DED) associated with meibomian gland dysfunction. SEECASE evaluated the efficacy, safety, and tolerability of NOV03 at 2 dosing regimens compared with a saline comparator in patients with DED. Methods: SEECASE was a prospective, multicenter, randomized, double-masked, saline-controlled clinical study. A total of 336 DED patients [tear film breakup time ≤5 seconds, abnormal meibum secretion, total corneal fluorescein staining (tCFS) score of 4 ≤ X ≤ 11 (National Eye Institute scale), Schirmer of ≥5 mm] were randomized in a 2:2:1:1 manner to NOV03 4 times daily (QID), NOV03 twice daily (BID), saline BID, and saline QID, respectively. The primary efficacy endpoint was tCFS staining at 8 weeks for both regimens. Secondary endpoints included visual analog scales and the Ocular Surface Disease Index questionnaire for symptom assessment. Results: The study met its primary endpoint, change from baseline of tCFS over control, for both dosing regimens QID and BID ( P < 0.001 and P = 0.009, respectively). NOV03 also showed pronounced improvement in various symptoms. For the Eye Dryness Score, changes from baseline were statistically significant compared with those of the control at week 8 [ P < 0.001 (QID) and P = 0.002 (BID)]. Benefits on tCFS and symptoms started at 2 weeks after start of treatment and were maintained over the study duration. The effects were dosing schedule dependent. NOV03 was well tolerated with instillation site reactions below 3% in both treatment regimes. Conclusions: The SEECASE study demonstrated that NOV03 improves signs and symptoms in patients with highly symptomatic evaporative dry eye disease.

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confidence: 99%

A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease

Tauber

Wirta²,

Sall

et al. 2020

Cornea

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“…Hence, it is necessary to conduct an intervention in preoperative dry eye symptoms in cataract patients complicated with dry eyes to mitigate dry eye symptoms after operation. Nevertheless, there are a few reports on the intervention in dry eye symptoms in cataract patients complicated with dry eyes before the operation at the present (21) . Therefore, the influences of preoperative application of artificial tears combined with rbFGF on the ocular surface function and the levels of inflammatory factors after operation in cataract patients complicated with dry eyes were explored in the study.…”

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confidence: 91%

Effects of the preoperative use of artificial tears combined with recombinant bovine basic fibroblast growth factor on cataract patients complicated with dry eyes

Xiao¹,

Huang²

2022

ABO

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To assess the effects of the preoperative application of artificial tears combined with recombinant bovine basic fibroblast growth factor on the ocular surface function and inflammatory factor levels after operation in cataract patients complicated with dry eyes. Methods: A total of 118 cataract patients (118 eyes) complicated with dry eyes treated from February 2019 to February2020 were assigned to control and observation groups (n=59 eyes/group) using a random number table. One week before the operation, the control group was administered 0.1% sodium hyaluronate eye drops (artificial tears), based on which the observation group received Beifushu eye drops (recombinant bovine basic fibroblast growth factor), both 6 times daily for 1 week. A comparison was made between the scores of clinical symptoms and the indices of ocular surface function, inflammatory factors in tears, and oxidative stress indices before and after the operation. The ocular surface function was evaluated by an ocular surface disease index questionnaire, tear film breakup-time assay, Schirmer's I test, and corneal fluorescein stain test. The inflammatory factors in tears were measured. Results: No significant differences were noted in the general data and clinical symptom score, ocular surface disease index, tear film breakup-time, Schirmer's I test score, fluorescein stain score, interleukin-6, tumor necrosis factor-alpha, malondialdehyde, superoxide dismutase, lipid peroxide, and total antioxidant capacity before treatment between the 2 groups (p>0.05). After treatment, the clinical symptom score, ocular surface disease index, fluorescein stain score, tumor necrosis factor-alpha, interleukin-6, malondialdehyde and lipid peroxide declined significantly, and tear film breakup-time, Schirmer's I test score, superoxide dismutase, and total antioxidant capacity increased in both the groups. The improvements in the clinical symptom score as well as in the indices of ocular surface function, inflammatory factors, and oxidative stress were more prominent in the observation group than in the control group (p<0.05). Conclusions: Artificial tears combined with recombinant bovine basic fibroblast growth factor before operation. significantly improved the ocular surface function, reduced inflammatory factors in tears, and alleviated dry eye symptoms after operation in cataract patients.

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“…At day 1, day 15 ± 2, day 29 ± 2, and day 57 ± 2, symptoms were assessed using a visual analog scale (VAS; range, 0-100 points, with 0 = no discomfort and 100 = maximal discomfort), a tool widely used for measuring subjective symptoms for the severity of eye dryness and symptoms (burning/stinging sensation, sticky feeling, foreign body sensation, itching, blurred vision, sensitivity to light, and pain). These symptoms are commonly evaluated in clinical studies of DED . DED severity was also assessed using a valid and reliable instrument, the OSDI questionnaire, consisting of 12 questions (total score range, 0-100, with higher scores representing a worse condition) .…”

Section: Methodsmentioning

confidence: 99%

“…These symptoms are commonly evaluated in clinical studies of DED. 21,[23][24][25] DED severity was also assessed using a valid and reliable instrument, the OSDI questionnaire, consisting of 12 questions (total score range, 0-100, with higher scores representing a worse condition). 26 Signs were assessed by tCFS score using the National Eye Institute scale (range, 0-15, with higher scores representing a worse condition).…”

Section: Clinical Assessmentsmentioning

confidence: 99%

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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Semi-fluorinated Alkane Eye Drops Reduce Signs and Symptoms of Evaporative Dry Eye Disease After Cataract Surgery

Cited by 9 publications

References 40 publications

A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease

A Randomized Clinical Study (SEECASE) to Assess Efficacy, Safety, and Tolerability of NOV03 for Treatment of Dry Eye Disease

Effects of the preoperative use of artificial tears combined with recombinant bovine basic fibroblast growth factor on cataract patients complicated with dry eyes

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

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