We know hormonal changes affect dry eye symptoms. While there are no randomized, double blinded controlled studies proving testosterone creams or drops helps, there are many observational studies noting a significant relief in dry eye symptoms in patients who use Testosterone cream or drops.

Below are all the studies to date on “testosterone” and “dry eye”.

The reason why testosterone would work in dry eye patients is related to a relative decrease in testosterone experienced as we get older, especially in women. This is especially true in patients with autoimmune diseases. A couple of summaries below shed more light on the complex pathway that can contribute to dry eyes. The most compelling report is a letter describing a series of patients who improved after the use of a Testosterone (=Androgen) patch. It was published in a reputible journal but was not a randomized, double blinded study.

Sandra Lora Cremers

ARG101 is a testosterone cream or gel formulation used to treat DES in
menopausal women. Waning androgen levels in women before, during, and
after menopause has been identified as a primary cause of DES in this
population. ARG101 is unique in that it is applied to the upper and
lower eyelids for transdermal delivery of testosterone directly to the
affected glands. Delivering the active pharmaceutical ingredient
transdermally allows better access to the glands and enables convenient
twice-daily dosing. ARG101 restores aqueous and lipid production thereby
restoring the natural process of tear production.

Clinical practice at the Southern College of Optometry (SCO) has
documented ARG101 efficacy and safety. Patients using ARG101 achieved a
51% increase in aqueous secretion (p=0.01) and a 68% increase in tear
breakup time, a measure of meibomian gland function, versus baseline
measurements. There was also a 51% (p=0.01) decrease in symptoms as
measured by the Ocular Severity Disease Index (OSDI), a validated
measure of DES symptoms. There have been no adverse events and,
importantly, no increase in intraocular pressure in patients using the
testosterone cream for three years. Results of the use of testosterone
in patients at SCO have been presented at the Annual Meeting of the
American Association of Optometrists in each year 2002-2006.

ARG102 is a progesterone cream or gel formulation used to treat DES in
men and younger women. The cross-reactivity between progesterone and
corticosteroid receptors in the ocular region is believed to activate
corticosteroid anti-inflammatory activity in the glands and on the
ocular surface, restoring normal aqueous and lipid production. ARG102 is
also applied to the upper and lower eyelids for transdermal delivery of
progesterone directly to the affected glands.

Patient data from clinical practice at SCO has shown that patients using
ARG102 had a 34% increase in tear breakup time (p=0.01) and a 20%
decrease in symptom severity (p=0.05) after only three weeks of use
versus baseline measurements. There were no reported adverse events or
increases in intraocular pressure. These results were presented at the
2006 Annual Meeting of the American Association of Optometrists.

ARG103 is a combination of testosterone and progesterone in a cream or
gel formulation used to treat previously untreated post-menopausal
women. Anecdotal results from SCO have shown promise in treating these
women who because of lack of treatment options may have more severe
glandular dysfunction.

These treatments share several characteristics which make them unique among current DES therapies and those in development:

■A patient-friendly application with a cream or gel formulation to the
outer upper and lower eyelids versus conventional drop application.
■Transdermal delivery of anti-inflammatory hormones directly to the affected glands.
■Restores the natural process of tear production versus tear replacement of conventional therapies.
■Convenient twice-daily dosing versus the frequent applications required by tear replacement therapies.
■No stinging or burning of the skin to which it is applied or of the ocular surface.

Reference:

http://www.argentisrx.com/content/show.asp?mne=pipeline