A Phase 2 interventional study of Testosterone gel 4.5% and Vehicle gel in Aqueous Tear Deficiency and Meibomian Gland Dysfunction of Bilateral Eyes (Disorder), sponsored by Southern California College of Optometry at Marshall B. Ketchum University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.
Sponsored by Southern California College of Optometry at Marshall B. Ketchum University · Phase 2, Interventional, and Treatment
The purpose of this research study is to evaluate the effectiveness and safety of applying androgen sex hormone (i.e., testosterone) gel on the eyelids in the treatment of dry eye patients. Several studies have demonstrated positive treatment effects in dry eye, but few have applied testosterone gels to the eyelids.
The purpose of this study is to examine the safety and efficacy of transdermal eyelid application of testosterone gel along with the length of any beneficial effect following cessation of treatment.
Moderate to severe dry eye subjects will be enrolled into a randomized controlled trial with assignment to either an \~ 4.5% FDA-approved androgen gel (Natesto®, Acerus Pharmaceuticals, Mississagua, Canada) or a placebo formulated similar to Natesto® without testosterone. The gel will be applied to both eyelids in the morning and 12 hours later on both eyelids for a 30 day treatment period
Subjects will fulfil DEWS II criteria for eligibility and further be classified as moderate or severe based on DEWS II recommendations. A standardized examination involving signs and symptoms of dry eye and monitoring function of the meibomian and lacrimal glands, as well as clinical tear and ocular surface measures, IOP, and serum testosterone levels, at baseline, following 30 days of testosterone application, and at one and two months post-treatment.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's enrollment of 24 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Southern California College of Optometry at Marshall B. Ketchum University is the lead sponsor of 19 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vehicle gel applied to eyelids twice per day
Drug: Vehicle gel
Testosterone gel 4.5% applied to eyelids twice per day
Drug: Testosterone gel 4.5%
Testosterone gel applied to eyelids twice per day
Also known as: androgen gel 4.5%
Vehicle gel applied to eyelids twice per day
Also known as: placebo
Tear Break up Time
Time to first dark spot appearance in the tear film
Time frame: From baseline to 4 weeks treatment
Lower Meibomian Gland Secretion Score (0 - 32 Scale)
8 central lower meibomian glands are evaluated using gentle (vs forceful) expression. Each secretion is given a score of 0 (clear normal meibum), 1 (cloudy low viscosity) 2 (thick, opaque, 3 inspissated or 4 (no secretion visible). One-half scale increments are used.
Time frame: From baseline to 4 weeks treatment
| Milestone | Vehicle Gel | Testosterone Gel 4.5% |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
Time to first dark spot appearance in the tear film
| seconds | Vehicle Gel | Testosterone Gel 4.5% |
|---|---|---|
| Tear Break up Time | 0.0 ± 1.2 | 2.9 ± 1.3 |
8 central lower meibomian glands are evaluated using gentle (vs forceful) expression. Each secretion is given a score of 0 (clear normal meibum), 1 (cloudy low viscosity) 2 (thick, opaque, 3 inspissated or 4 (no secretion visible). One-half scale increments are used.
| units on a scale | Vehicle Gel | Testosterone Gel 4.5% |
|---|---|---|
| Lower Meibomian Gland Secretion Score (0 - 32 Scale) | 0.7 ± 0.3 | 5.5 ± 2.1 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Gel | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Testosterone Gel 4.5% | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Categorical(Participants) | Vehicle Gel | Testosterone Gel 4.5% | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 10 | 20 |
| >=65 years | 2 | 2 | 4 |
| Age, Continuous(years) | Vehicle Gel | Testosterone Gel 4.5% | Total |
|---|---|---|---|
| Mean | 51.0 ± 14.6 | 52.9 ± 11.3 | 52.0 ± 12.8 |
| Sex: Female, Male(Participants) | Vehicle Gel | Testosterone Gel 4.5% | Total |
|---|---|---|---|
| Female | 9 | 9 | 18 |
| Male | 3 | 3 | 6 |
| Race (NIH/OMB)(Participants) | Vehicle Gel | Testosterone Gel 4.5% | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 3 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 6 | 9 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vehicle Gel | Testosterone Gel 4.5% | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| Fluorescein tear breakup time(seconds) | Vehicle Gel | Testosterone Gel 4.5% | Total |
|---|---|---|---|
| Mean | 3.3 ± 0.9 | 3.6 ± 1.2 | 3.5 ± 1.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2023 to primary completion in Apr 2024, 12 months.
Results were first posted in May 2025, 1 year after primary completion.
Of 91 phase 2 interventional studies under Dry Eye Syndromes, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 12. This study's 12 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Testosterone
Southern California College of Optometry at Marshall B. Ketchum University