Clinical Development

The Pros and Cons of Dry-Eye Technologies

A look at the advantages and disadvantages of time-honored methods as well as new techniques and devices.

As we enter the dawn of dry-eye season and close the chapter on another year, it’s an appropriate time to reflect on the current state of dry-eye diagnosis and treatment as well as the prospects for therapeutic development in the coming year and beyond. In August, we ran through a list of dry-eye diagnostic tests, and discussed the critical value of a thorough patient history and a comprehensive discussion between doctor and patient about the patient’s ocular health.

In the Blink of an Eye

Although not often researched, studying blinks can serve as an important diagnostic tool for eye care practitioners.

Picture driving down the freeway in your Mercedes Benz S-600 after a long day of treating patients.1 You didn’t get enough sleep last night and you feel fatigue start to set in. Your eyes water, you blink faster, your head starts to nod… Beep, beep, beep! A set of alarms start ringing and you’re jolted back to reality—you almost fell asleep at the wheel. Now, how did your car know this?

Glaucoma and Dry Eye: A Tough Combo

How chronic glaucoma treatment can give rise to ocular surface disease, and how you can treat them both.
Glaucoma and Dry Eye: A Tough Combo

As our patients age, an increased interest and heightened awareness of the changes occurring on the ocular surface is necessary. It’s not uncommon in this older patient population to see age-related changes on the ocular surface that affect the protective and nutrient functions of the tear film. These changes can include laxity of the lids, dropout of the meibomian glands, decrease in goblet cells and an increase in dry eye related to a decrease in acinar cells of both the main and accessory lacrimal glands. In fact, aging itself is a drying process.

The Pros and Cons of Dry-Eye Tests

The various tests of ocular surface health can yield many insights, but they're not perfect.
Dry Eye Tests

Dry eye is a multifactorial disease that affects the quality and quantity of tears and alters the ocular surface. Patients may experience varying degrees of discomfort, including symptoms such as ocular burning, stinging, grittiness, foreign body sensation, sensitivity to light and blurriness.1 Signs such as keratitis are often noted to a greater or lesser degree.

  • 1. Abelson MB, Ousler GW, 3rd, Nally LA, Emory TB. Dry eye syndromes: diagnosis, clinical trials and pharmaceutical treatment—'improving clinical trials'. Adv Exp Med Biol 2002;506(Pt B):1079-1086.

RegeneRx Set to Begin Enrolling Phase 2 Dry Eye Trial

First Patients Expected to Begin Treatment on August 13th
RegeneRx

RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX) ("the Company" or "RegeneRx") has announced that it is set to begin a Phase 2 clinical trial in 72 patients with dry eye syndrome. The Company anticipates enrollment of the first patients on August 13th, and expects preliminary data from the study to be available in October 2011. The trial is a double-masked, placebo-controlled trial testing the safety and efficacy of RGN-259, the Company's proprietary preservative-free eye drops, against a placebo. Patients will receive RGN-259 or placebo twice daily for 30 days.

Mimetogen Pharmaceuticals Inc. Announces Positive Top Line Data from Phase II Clinical Trial of MIM-D3 for Dry Eye Disease

Mimetogen Pharmaceuticals Inc.

Mimetogen Pharmaceuticals Inc. (“Mimetogen”) today announced positive top line data from a Phase II clinical trial with MIM-D3, its lead drug for the treatment of dry eye. The trial demonstrated statistically significant improvements in signs and symptoms with its low (1%) and high (5%) doses of MIM-D3, together with excellent safety and tolerability profiles. Mimetogen is in the process of completing its analysis of the data, and intends to present further details at a future medical conference.

It is Time to Think About the Blink

In addition to defending the eye from particles and allergens, the blink can help diagnose certain diseases as well.
Staining will indicate when the tear film is breaking up and the surface is unpr

It's amazing to think of how complicated a seemingly simple action can be. The "blink of an eye" is an often-used phrase to describe things that begin and end before we have time to even realize they're happening. And blinking, the autonomic, reflexive closing of the eye is one of those apparently simple actions that, upon closer inspection, is exceedingly complex. It's also an absolutely critical aspect of corneal and conjunctival defense against allergens, pollutants and environmental poisons.

Identifying Subgroups of Dry Eye Patients

Constructing an extensive database of patients will give your practice a well-defined dry eye population for potential clinical investigation.

Dry eye syndrome may be one of the most common diseases that eye care providers encounter in daily practice. Patients who present with symptoms are diagnosed with dry eye after they undergo diagnostic testing. Yet, the diagnostic tools available to clinicians to clearly define dry eye have been limited or underutilized. Although an objective measurement is the only way to definitively diagnose dry eye, virtually no diagnostic tools, with the exception of tear osmolarity, are reimbursable.

Dry Eye Pipeline Full of Potential

Anti-inflammatories, resolvins, delivery systems, mucin secretagogues are under study
Dry Eye Pipeline

Dry eye syndrome has been estimated to affect more than 5 million Americans,1 yet there is only one FDA-approved eye drop, cyclosporine ophthalmic emulsion 0.05% (Restasis, Allergan), for its treatment. A recent survey found that about 94% of eyecare practitioners have expressed dissatisfaction with existing treatments for dry eye and want more treatment options.2

  • 1. The epidemiology of dry eye disease: report of the Epidemiology Subcommittee of the International Dry Eye WorkShop(2007). Ocul Surf. 2007;5:93-107.
  • 2. Asbell PA, Spiegel S.

Dry-Eye Studies: Beware These Pitfalls

Everything from environmental and seasonal factors to the placebo effect can confound a study’s results.
Dry-Eye Studies: Beware These Pitfalls

For those patients who suffer from dry eye, finding relief can be next to impossible. Even individuals with normal ocular health can experience dry-eye symptoms in adverse conditions, such as in airplanes and arid, windy environments, or while performing visual tasks. Dry eye is a disease that is exacerbated by a number of environmental, seasonal and regional challenges. In addition to these stresses, certain factors can be pitfalls for dry eye clinical trials, such as the placebo effect, which we discussed in this column last year (“The Placebo Effect and Other Confounders,” June 2010).