PurposeThe aim of this study was to evaluate the efficacy of a lipid containing emollient eye drop, Soothe XP, which was reformulated in 2014 with a more stable preservative and buffer system, compared to a control, non-emollient, eye drop (Systane Ultra) in improving lipid layer thickness (LLT) in subjects with dry eye due to meibomian gland dysfunction (MGD).Patients and methodsThis prospective single-center, open-label, cross-over, examiner masked-study enrolled subjects aged 30–75 years with lipid-deficient dry eye and a clinical diagnosis of MGD as determined by a slit lamp examination, an evaluation of meibomian gland drop out with meibography, and a standard patient evaluation of eye dryness questionnaire of >5. Eligibility was then determined by a LLT of <75 nm at baseline and the inability to increase LLT ≥15 nm with three blinks, as determined by interferometric methods. Subjects were randomized to receive a single emollient or non-emollient eye drop at Visit 1 and were crossed over for the alternate treatment at Visit 2. At each visit, LLT was measured prior to and 15 minutes following the instillation of the assigned eye drop. The primary endpoint was the change in LLT from baseline.ResultsSubjects (n=40) were enrolled and 35 completed the two study arms. Mean (±SD) patient age was 55.7 years (10.9) and 69% were female. Mean (±SD) LLT at baseline was 49.5 nm (9.2). Instillation of Soothe XP resulted in an increase in LLT to 77.5 nm (29.3) 15 minutes following drop instillation, which is an increase of 28.0 nm (27.4) (P<0.001). In contrast, LLT 15 minutes after the instillation of Systane Ultra was 50.8 nm (14.1), which was not statistically significant when compared to the baseline LLT.ConclusionIn this study of subjects with MGD, the emollient, or lipid containing eye drop, increased the LLT of tears when measured 15 minutes after instilling a single eye drop.

ImportanceThe global prevalence of myopia is predicted to approach 50% by 2050, increasing the risk of visual impairment later in life. No pharmacologic therapy is approved for treating childhood myopia progression.ObjectiveTo assess the safety and efficacy of NVK002 (Vyluma), a novel, preservative-free, 0.01% and 0.02% low-dose atropine formulation for treating myopia progression.Design, Setting, and ParticipantsThis was a double-masked, placebo-controlled, parallel-group, randomized phase 3 clinical trial conducted from November 20, 2017, through August 22, 2022, of placebo vs low-dose atropine, 0.01% and 0.02% (2:2:3 ratio). Participants were recruited from 26 clinical sites in North America and 5 countries in Europe. Enrolled participants were 3 to 16 years of age with −0.50 diopter (D) to −6.00 D spherical equivalent refractive error (SER) and no worse than −1.50 D astigmatism.InterventionsOnce-daily placebo, low-dose atropine, 0.01%, or low-dose atropine, 0.02%, eye drops for 36 months.Main Outcomes and MeasuresThe primary outcome was the proportion of participants’ eyes responding to therapy (&amp;lt;0.50 D myopia progression at 3 years). Secondary efficacy outcomes included mean change from baseline in SER and axial length at month 36 in a modified intention-to-treat population (mITT; participants 6 to 10 years of age at baseline). Safety measurements for treated participants (3 to 16 years of age) were reported.ResultsA total of 576 participants were randomly assigned to treatment groups. Of these, 573 participants (99.5%; mean [SD] age, 8.9 [2.0] years; 315 female [54.7%]) received trial treatment (3 participants who were randomized did not receive trial drug) and were included in the safety set. The 489 participants (84.9%) who were 6 to 10 years of age at randomization composed the mITT set. At month 36, compared with placebo, low-dose atropine, 0.01%, significantly increased the responder proportion (odds ratio [OR], 4.54; 95% CI, 1.15-17.97; P = .03), slowed mean SER progression (least squares mean [LSM] difference, 0.24 D; 95% CI, 0.11 D-0.37 D; P &amp;lt; .001), and slowed axial elongation (LSM difference, −0.13 mm; 95% CI, −0.19 mm to −0.07 mm; P &amp;lt; .001). At month 36, compared with placebo, low-dose atropine, 0.02%, also showed benefit but did not significantly increase the responder proportion (OR, 1.77; 95% CI, 0.50-6.26; P = .37) or slow mean SER progression (LSM difference, 0.10 D; 95% CI, −0.02 D to 0.22 D; P = .10) but did slow mean axial elongation (LSM difference, −0.08 mm; 95% CI, −0.13 mm to −0.02 mm; P = .005). There were no serious ocular adverse events and few serious nonocular events; none were judged as associated with atropine.Conclusions and relevanceResults of this randomized clinical trial suggest efficacy for low-dose atropine, 0.01%, across all 3 main end points compared with placebo. The efficacy and safety observed suggest that low-dose atropine may provide a treatment option for childhood myopia progression.Trial RegistrationClinicalTrials.gov Identifier: NCT03350620

Purpose Dry eye disease (DED) is often managed with over-the-counter eye drops. This study evaluated the diurnal effects of a single drop of two ocular lubricants (nanoemulsion vs. non-emollient) on tear film lipid layer thickness (LLT) and symptoms of ocular dryness. Subjects were also assessed after 1 month of nanoemulsion eye drop use. Methods Part 1 was a cross-over comparison of a nanoemulsion and a non-emollient eye drop. LLT and dry eye symptoms were measured at baseline and at 15 min, 1 h, 2 h, 4 h and 6 h after instillation of each drop. Part 2 was a 1-month observational study assessing LLT and symptoms after 30-day use of the nanoemulsion drop four times daily (qid). Results Total of 20 subjects completed the study (mean age = 45.6 ± 7.9, 15 female). Part 1 found a significant increase in average LLT 15 min after nanoemulsion drop instillation in the overall and inferior third of the tear film for subjects with baseline LLT values <50 nm. Average LLT values did not increase after use of the non-emollient. Symptoms of dryness improved up to 6 h following instillation of both drops. Part 2 results found that using the nanoemulsion eye drop for 1 month improved symptoms reported on symptom surveys. Conclusion Nanoemulsion eye drop use increased average LLT in subjects with low baseline levels. Statistically and clinically significant improvement in symptoms were found on symptom surveys after qid-use (four times a day) of the nanoemulsion drop. Results suggest that a nanoemulsion eye drop can benefit subjects with dry eye symptoms.

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