Call to action: treating dry eye disease and setting the foundation for successful surgery

Donaldson, Kendall E.; Parkhurst, Gregory; Saenz, Bobby; Whitley, Walter O.; Williamson, Blake K.; Hovanesian, John

doi:10.1097/j.jcrs.0000000000000844

Cited by 12 publications

(17 citation statements)

References 38 publications

(97 reference statements)

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“…A compromised ocular surface and punctate erosions of the cornea may lead to inaccurate biometry measurements before the procedure and postoperative dissatisfaction. [5][6][7][8][9] The ESSENCE-2 study demonstrated superiority to vehicle in the primary sign end point tCFS score at day 29, thereby confirming ESSENCE-1 results. 16 In addition, the onset of effect in tCFS reached statistical significance at day 15, which is substantially faster than reported results with other products used for the treatment of DED.…”

Section: Discussionmentioning

confidence: 64%

“…The importance of this is that many of these patients are candidates for cataract surgery. A compromised ocular surface and punctate erosions of the cornea may lead to inaccurate biometry measurements before the procedure and postoperative dissatisfaction …”

Section: Discussionmentioning

confidence: 99%

“…DED is marked by changes in ocular surface and tear film parameters and accompanied by eye discomfort and blurred vision symptoms . A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact postoperative visual outcomes . There is no criterion standard for DED disease management.…”

Section: Introductionmentioning

confidence: 99%

“…4 A compromised ocular surface secondary to DED may also compromise refractive measurements before keratorefractive and phacorefractive surgeries and adversely impact postoperative visual outcomes. [5][6][7][8][9] There is no criterion standard for DED disease management. A staged management according to severity of physician-measured findings is recommended.…”

mentioning

confidence: 99%

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Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease

Akpek

Wirta

Downing³

et al. 2023

JAMA Ophthalmol

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ImportanceDry eye disease (DED) is a common public health problem with significant impact on vision-related quality of life and well-being of patients. Medications with rapid onset of action and a good tolerability profile remain an unmet need.ObjectiveTo assess efficacy, safety, and tolerability of a water-free cyclosporine ophthalmic solution, 0.1% (CyclASol [Novaliq GmbH]), applied twice daily in DED compared with vehicle.Design, Setting, and ParticipantsCyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (ESSENCE-2) was a phase 3, multicenter, randomized, double-masked, vehicle-controlled clinical study conducted from December 5, 2020, to October 8, 2021. Following a 14-day run-in period with an artificial tear administered 2 times per day, eligible participants were randomly assigned 1:1 to the treatment groups. Patients with moderate to severe DED were included in the study.InterventionsCyclosporine solution vs vehicle administered 2 times per day for 29 days.Main Outcomes and MeasuresThe primary end points were changes from baseline in total corneal fluorescein staining (tCFS; 0-15 National Eye Institute scale) and in dryness score (0-100 visual analog scale) at day 29. Conjunctival staining, central corneal fluorescein staining, and tCFS responders were also assessed.ResultsA total of 834 study participants were randomly assigned to cyclosporine (423 [50.7%]) or vehicle (411 [49.3%]) groups at 27 sites. Participants had a mean (SD) age of 57.1 (15.8) years, and 609 (73.0%) were female individuals. The majority of participants self-identified in the following race categories: 79 Asian (9.5 %), 108 Black (12.9%), and 635 White (76.1%). Participants treated with cyclosporine solution had greater improvement in tCFS (−4.0 grades) than the vehicle group (−3.6 grades) at day 29 (change [∆] = −0.4; 95% CI, −0.8 to 0; P = .03). The dryness score showed treatment benefits from baseline in both groups: −12.2 points for cyclosporine and −13.6 points for vehicle (∆ = 1.4; 95% CI, −1.8 to 4.6; P = .38). In the cyclosporine group, 293 participants (71.6%) achieved clinically meaningful reductions of 3 grades or higher in tCFS vs 236 (59.7%) in the vehicle group (∆ = 12.6%; 95% CI, 6.0%-19.3%; P &lt; .001). These responders showed greater improvement in symptoms at day 29 including dryness (∆ = −4.6; 95% CI, −8.0 to −1.2; P = .007) and blurred vision (Δ = −3.5; 95% CI, −6.6 to −4.0; P = .03) compared with nonresponders.Conclusions and RelevanceThe ESSENCE-2 trial confirmed that treatment with a water-free cyclosporine solution, 0.1%, results in early therapeutic effects on the ocular surface compared with vehicle. The responder analyses suggest that the effect is clinically meaningful in 71.6% of participants in the cyclosporine group.Trial RegistrationClinicalTrials.gov Identifier: NCT04523129

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Section: Discussionmentioning

confidence: 64%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease

Akpek

Wirta

Downing³

et al. 2023

JAMA Ophthalmol

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“…[48][49][50] External and Behavioral Factors Several external factors have been linked to DED, including use of contact lenses and certain ocular medications. 6,[51][52][53][54] Identification of these factors, specifically the patient's medical and ocular history, is important because it allows for modifications that may improve the patient's DED. For example, use of topical antiglaucoma medications has been associated with DED, 52,53,55,56 which may be caused by preservatives such as benzalkonium chloride.…”

Section: Inflammation In Dry Eye Diseasementioning

confidence: 99%

Personalized Management of Dry Eye Disease: Beyond Artificial Tears

Matossian¹,

Crowley²,

Periman³

et al. 2022

OPTH

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Dry eye disease (DED) is a multifactorial disease of the ocular surface that may be accompanied by discomfort and visual disturbances to a level that reduces quality of life. Artificial tears are a common first-line therapy for DED that aim to supplement the tear film but do not address the underlying causes of DED. Because of the complexity and variability of the disease, personalized treatment beyond artificial tears is important for successful management. This review describes artificial tears and the current knowledge in the personalized approach to the management of DED. There is evidence that artificial tears can reduce symptoms and signs of DED; however, a proportion of patients have been found to show limited or no improvement with artificial tears. Furthermore, the effectiveness of artificial tears may depend on patient compliance and type of artificial tear product used. Personalized management of DED with other treatments involves identifying features of the disease, including the subtype of DED, the presence of inflammation, and the coexistence of external and behavioral contributing factors. Various measures exist to characterize DED, including assessments of the tear film lipid layer, the meibomian glands, tear volume, tear osmolarity, and matrix metalloproteinase 9 levels. Because individuals can show variable features, the most prominent clinical findings, comorbidities, triggering events, and treatment history should be considered to determine the best treatment choices for patients.

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Varenicline Solution Nasal Spray for the Treatment of Dry Eye Disease Following LASIK

Ferguson,

Messer,

Risbrudt

et al. 2024

Ophthalmol Ther

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Introduction The purpose of this study is to evaluate the use of a varenicline solution nasal spray (VNS) for reducing the signs and symptoms of dry eye following laser in situ keratomileusis (LASIK). Methods Subjects electing to undergo LASIK were randomized to VNS (study group) or placebo/vehicle (control group) and initiated treatment with the nasal spray twice daily 28 days prior to surgery with continued treatment for 84 days following LASIK. After initiation of treatment, subjects were seen on the day of surgery and postoperatively on Days 1, 7, 28, 84 (3 months) and 168 (6 months). The primary outcome measure was the mean change in NEI-VFQ-25, a 25-item dry eye questionnaire, from baseline to 3 months. The second primary outcome measure was the mean change in corneal fluorescein staining. Secondary outcome measures included evaluation of tear break-up time, Schirmer testing, tear osmolarity and eye dryness score (EDS). Results Twenty subjects were enrolled in each group and successfully underwent LASIK. Both groups demonstrated an improvement in the National Eye Institute Visual Function Questionnaire (NEI-VFQ) at 3 months. The study group demonstrated improved corneal staining scores at months 1 and 3. Similarly, the study group demonstrated improvement in tear osmolarity scores versus the placebo group at the same time points. Although the study group was numerically greater than placebo for each time point for both corneal staining and tear osmolarity, the differences were not statistically significant for any primary or secondary outcome measures. Conclusion VNS is a dry eye treatment option for patients following LASIK and may have potential benefit for patients hoping to avoid additional topical medications. The results were not statistically significant compared to placebo in this trial, and further investigation of the use of VNS following LASIK in a larger trial would be beneficial.

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Call to action: treating dry eye disease and setting the foundation for successful surgery

Abstract: This review discussed the predisposing and exacerbating factors for DED and the importance of adequately treating DED prior to surgery.

Cited by 12 publications

References 38 publications

Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease

Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease

Personalized Management of Dry Eye Disease: Beyond Artificial Tears

Varenicline Solution Nasal Spray for the Treatment of Dry Eye Disease Following LASIK

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