Kala Pharmaceuticals, Inc. (Kala), a developer of innovative ophthalmic products based on its proprietary mucus-penetrating particle (MPP) technology, announced positive top-line results from a Phase 2 clinical trial of KPI-121, its nanoparticle loteprednol etabonate MPP product candidate, in patients with dry eye disease. KPI-121 achieved statistical significance for the primary sign endpoint of bulbar conjunctival hyperemia, and promising trends were observed for key symptom endpoints.

The Phase 2 multi-center, randomized, double-masked, parallel-group trial compared 0.25% KPI-121 to vehicle, each dosed four times a day for 28 days, in 150 patients with dry eye disease. Patients treated with KPI-121 achieved statistical significance for the primary clinical sign endpoint of bulbar conjunctival hyperemia at day 29 of the trial (p=0.0387). Although KPI-121 did not achieve statistical significance for the primary symptom endpoint of ocular discomfort, the trial showed promising trends toward improvement in this and other symptom endpoints, particularly in patients with more severe baseline ocular discomfort. KPI-121 was generally well tolerated, with no significant treatment-related safety findings observed during the course of the trial. The only treatment-emergent adverse event reported in greater than 3% of patients was instillation site pain, which was reported in 6.9% of patients treated with KPI-121 compared to 3.8% of patients treated with vehicle.

KPI-121 is a novel nanoparticle formulation of loteprednol etabonate utilizing Kala’s proprietary MPP technology to enhance penetration into target tissues of the eye. KPI-121 has been studied in multiple clinical trials, including 1% and 0.25% formulations for the treatment of post-surgical ocular inflammation and pain and a 0.25% formulation for dry eye and meibomian gland disease.

For more information on the company, visit www.kalarx.com.

There has been a growing academic interest in myopia management over the past few years, but there is little information on what is actually happening in clinical practice. As part of an global initiative supported by the British Contact Lens Association, Contact Lens Spectrum, Optometry Australia, and the International Association of Contact Lens Educators amongst many others, a survey on myopia management has been developed. We would value just five minutes or less of your time to complete the survey at https://www.surveymonkey.com/s/JHLWGKP to share your current thoughts and practice. The information gathered will allow us to report back what is happening across the globe as well as what your peers are thinking/doing.

Thank you in advance for your time.

We thank Dr. Bagga and Mr. Mandal for these images and we welcome photo submissions from our other readers! It is easy to submit a photo for consideration for publishing in Contact Lenses Today. Simply visit http://www.cltoday.com/upload/upload.aspx to upload your image. Please include an explanation of the photo and your full name, degree or title and city/state/country.

Have you ever sat and watched an eagle come down and swoop a fish from the water. Like most things that eagles do, it is very graceful. But the view of a pelican fishing is a sight. These birds look like they are coming down to grab something and then SPLASH they plummet into the water like a belly flop off the high dive. Sometimes fishing can be graceful and sometimes it is sloppy and messy, but ask that pelican if he got his fish, absolutely. Fitting contact lenses on difficult corneas can be the same way. Even for the best of us, sometimes things just don’t always go exactly as we expect. I have spoken to plenty of practitioners who just refer their keratoconus patients into surgery rather than attempting contact lens fitting because they have encountered challenging patients that took them 6 months to fit. These challenging patients certainly can benefit from a try and try again approach, even if it isn’t clean. A success, regardless of how you go about getting it, is always rewarding, just ask a pelican next time you see one.

Scleral GP Lenses and Hydrogen Peroxide Cases

For those scleral gas permeable (GP) patients searching for a preservative-free disinfecting solution, a hydrogen peroxide system may be the answer.¹ Practitioners should note, however, that most commercially-available basket-style cases packaged with hydrogen peroxide solutions can only accommodate lens diameters up to 16.5 mm (and even less for lenses with large sagittal depths).²

For patients whose lenses exceed this diameter, a larger case is available.² It must be noted, however, that this case does not include a catalytic disc or any other means of neutralizing the hydrogen peroxide. It is advised that the patient pry the disc off his smaller H₂O₂ case and attach it to the post at the bottom of the case’s lens holder. It must also be noted that most catalytic discs need to be replaced every 3 months, as residual hydrogen peroxide may remain after approximately 90 uses.³

Lastly, I recommend verifying that a patient’s scleral lenses fit into a particular hydrogen peroxide system’s case before recommending it.

1. http://www.cltoday.com/issues/CLToday_032215.htm
2. http://www.clspectrum.com/articleviewer.aspx?articleID=112235
3. Kaplan EN, Gundel RE, Sosale A et al. Residual peroxide as a function of platinum disc age. CLAO J. 1992;18:149.

Meibomian gland dysfunction (MGD) appears to be the most common cause of evaporative dry eye, in which the meibum has an altered chemical structure that increases its melting point. Eyelid warming masks slowly transfer heat, preferably between 40 and 45°C to the inner meibomian glands, in an attempt to melt or soften the stagnant meibum. This ex vivo study evaluates the heat retention properties of commercially available masks over a 12-minute interval.

Five eyelid-warming masks (MGDRxEyeBag, EyeDoctor, Bruder, Tranquileyes, Thera Pearl) were heated following manufacturer's instructions and heat retention was assessed at 1-minute intervals for 12 minutes on a non-conductive surface. A facecloth warmed with hot tap water was used as comparison.

All masks reached above 40°C within the first 2 minutes after heating and remained so for 5 minutes, with the exception of the facecloth, which lasted only 3 minutes and quickly degraded to 30°C within 10 minutes. The Bruder and Tranquileyes reached >50°C, after heating and the Bruder maintained >50°C for nearly 6 minutes. The MGDRx EyeBag, and Thera Pearl had the most stable heat retention between 2 and 9 minutes, remaining between the targeted temperature.

Heat retention profiles are different for commercially available eyelid warming masks. This ex vivo study highlights that despite the popularity of the time-honored facecloth, it is poor at retaining the desired heat over a 5-10 minute interval. Clinical studies need to corroborate these results, remembering that ocular tissue parameters may be factors to consider.

Lacroix Z, Léger S, Bitton E. Ex vivo heat retention of different eyelid warming masks. Cont Lens Anterior Eye. 2015 Feb 27. pii: S1367-0484(15)00007-7. doi: 10.1016/j.clae.2015.01.005. [Epub ahead of print]