Aqueous Tear DeficiencyPhase 2NCT06154200
Eyelid Androgen Treatment in Dry Eye
A Phase 2 study testing Testosterone gel 4.5% in people with Aqueous Tear Deficiency and Meibomian Gland Dysfunction of Bilateral Eyes (Disorder), run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aqueous Tear Deficiency, Meibomian Gland Dysfunction of Bilateral Eyes (Disorder)
- What is being tested?
- Testosterone gel 4.5%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2023to 30 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe dry eye (TBUT < 6.0 seconds, corneal staining > grade 1.5, evidence of meibomian gland secretion compromise or Schirmer < 5 mm wetting in 5 minutes)
- Age over 18
- Mild ectropion
- Previous contact lens wearers IF no wear for prior 6 months
- Punctal plugs if more than three months since placement
- Systemic tetracyclines, antihistamines if consistent dosing
- Sjogren's syndrome and related autoimmune conditions can be enrolled
- Patients using topical dry eye treatments (e.g., Restasis) if willing to discontinue for 30 days
Who cannot join
- If artificial tears or autologous serum used on day of study
- Ocular surgery if less than 12 months
- Punctal plugs if within 3 months of plug insertion
- Contact Lens wear within the six months prior to study
- PSA levels greater than 4 ng/ml or BPH
- Recent or current thrombolism
Show all 13Show fewer
- Recent or current cardiovascular events (e.g., MI, stroke)
- Recent or current liver disorders
- Concurrent use of topical medications; e,g., topical glaucoma medications
- Diabetics
- Females of child-bearing age if not on reliable birth control
- History of breast cancer
- Cannot be taking insulin, warfarin or systemic corticosteroids
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California College of Optometry at Marshall B. Ketchum University
Fullerton, California, 92831
About this study
Official title: A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye
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.
Read the detailed description
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.
- Being tested
- Testosterone gel 4.5%, Vehicle gel
- Keywords
- testosterone, fluorescein breakup time, androgen, dry eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gel 4.5%Drug
Also called androgen gel 4.5%
Testosterone gel applied to eyelids twice per day
Vehicle gelDrug
Also called placebo
Vehicle gel applied to eyelids twice per day
| Study group | Role | What they receive |
|---|---|---|
| Vehicle Gel | Placebo comparator | Vehicle gel applied to eyelids twice per day Receives: Drug: Vehicle gel |
| Testosterone gel 4.5% | Active comparator | Testosterone gel 4.5% applied to eyelids twice per day Receives: Drug: Testosterone gel 4.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Break up Time
Time to first dark spot appearance in the tear film
Measured: From baseline to 4 weeks treatment
Secondary outcomes (1)
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.
Measured: From baseline to 4 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start2 Apr 2023
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aqueous Tear DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects randomized to either placebo or drug
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jerry Paugh, Southern California College of Optometry at Marshall B. Ketchum University
- Investigators
- Jerry Paugh, OD, PhD, Principal investigator, SCCO at MBKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154200
- Sponsor's protocol ID
- 21-18
- Status last verified
- May 2025
- First submitted
- 20 Nov 2023
- Last updated
- 25 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial of Eyelid Androgen Treatment in Dry Eye
- ClinicalTrials.gov ID
- NCT06154200
- Acronym / sponsor ID
- 21-18
- Keywords
- testosterone, fluorescein breakup time, androgen, dry eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Southern California College of Optometry at Marshall B. Ketchum UniversityUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 4 Dec 2023 (actual)
- Results
- Posted 25 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects randomized to either placebo or drug
| Arm | Type | Receives |
|---|---|---|
| Vehicle Gel | Placebo comparator | Drug: Vehicle gelVehicle gel applied to eyelids twice per day |
| Testosterone gel 4.5% | Active comparator | Drug: Testosterone gel 4.5%Testosterone gel 4.5% applied to eyelids twice per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Moderate to severe dry eye (TBUT < 6.0 seconds, corneal staining > grade 1.5, evidence of meibomian gland secretion compromise or Schirmer < 5 mm wetting in 5 minutes)
- Age over 18
- Mild ectropion
- Previous contact lens wearers IF no wear for prior 6 months
- Punctal plugs if more than three months since placement
Key exclusion criteria (13 listed)
- If artificial tears or autologous serum used on day of study
- Ocular surgery if less than 12 months
- Punctal plugs if within 3 months of plug insertion
- Contact Lens wear within the six months prior to study
- PSA levels greater than 4 ng/ml or BPH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone gel 4.5%Also: androgen gel 4.5%Testosterone gel applied to eyelids twice per day | Drug | Testosterone gel 4.5% |
| Vehicle gelAlso: placeboVehicle gel applied to eyelids twice per day | Drug | Vehicle Gel |
Primary outcome
Tear Break up Time
Time frame: From baseline to 4 weeks treatment
Time to first dark spot appearance in the tear film
1 secondary outcome
Lower Meibomian Gland Secretion Score (0 - 32 Scale)
Time frame: From baseline to 4 weeks treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerry Paugh, OD, PhD principal investigator
SCCO at MBKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Testosterone gel 4.5% in people with Aqueous Tear Deficiency and Meibomian Gland Dysfunction of Bilateral Eyes (Disorder), run by Southern California College of Optometry at Marshall B. Ketchum University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear Break up Time (time frame: From baseline to 4 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.