Dry Eye DiseaseEarly Phase 1NCT05995392
The Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye Disease
A Early Phase 1 study testing Topical spironolactone ophthalmic solution, 0.005 mg/cc in people with Dry Eye Disease, run by Richard W Yee, MD at 1 site in United States.
Trial summary
The objective of this study is to evaluate the clinical efficacy of topical spironolactone ophthalmic solution, 0.005 mg/cc in subjects with dry eye disease compared to placebo. The hypothesis for this study is that topical spironolactone ophthalmic solution will be beneficial in the management of signs and symptoms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Topical spironolactone ophthalmic solution, 0.005 mg/cc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2023to Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- SANDE questionnaire ≥30 mm
- Schirmer test without anesthesia ≥2 mm/5 minutes
- Corneal fluorescein staining score of ≥1 (0-3 point scale) in at least 1 corneal region of the 5 zones based on the NEI scale, with particular attention paid to the inferior region
- The same eye (eligible eye) must fulfill all the above criteria
- No lagophthalmos, entropion, ectropion
- No significant conjunctivochalasis (graded <2 on a 0-4 point scale)
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- Best corrected distance visual acuity (BCDVA) score of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) (20/200 Snellen value) in both eyes at the baseline visit
- Intraocular pressure of ≥10 to <21 mmHg
- If a female of childbearing potential, have a negative pregnancy test
- Only patients who satisfy all Informed Consent requirements may be included in the study
- The patient must read, sign and date the Informed Consent document before any study related procedures are performed
- The Informed Consent form signed by patients must have been approved by the Institutional Review Board (IRB) / Independent Ethics Committee (IEC) for the current study
- Patients must have the ability and willingness to comply with study procedures
- Ability to speak and understand the English language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments
Who cannot join
- Evidence of an active ocular infection, in either eye
- Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study
- History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye
- Intraocular inflammation defined as Tyndall score >0
- Systemic disease not stabilized within 1 month before Visit 1 (e.g. diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or incompatible with the frequent assessment required by the study
- Patient had a serious adverse reaction or significant hypersensitivity to any drug or chemically related compounds or had a clinically significant allergy to drugs, foods, amide local anesthetics, or other materials including commercial artificial tears that is judged by the investigator to be incompatible with the study
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- Females of childbearing potential (those who are not surgically sterilized or post- menopausal for at least 1 year) are excluded from participation in the study if they meet any one of the following conditions:
- are currently pregnant
- have a positive result at the urine pregnancy test (Baseline/Day 0)
- intend to become pregnant during the study treatment period
- are breast-feeding
- are not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected - and/or mechanical barrier methods - spermicide in conjunction with a barrier such as a condom or diaphragm or Intra Uterine Device (IUD) - during the entire course of and 30 days after the study treatment period ends
- Any concurrent medical condition, that in the judgment of the PI, might interfere with the conduct of the study, confound the interpretation of the study results, or endanger the patient's well-being
- Use of topical, nasal, or oral antihistamine within 24 hours prior to or during study enrollment
- Use of oral spironolactone within 6 months prior to or during study enrollment
- Previous use of topical spironolactone ophthalmic solution
- Unstable use of topical cyclosporine, topical corticosteroids, artificial tears, lid scrubs, or any other topical drug for the treatment of dry eye in either eye prior to and during study enrollment
- Contact lenses use at any time 30 days prior or during study enrollment
- Cauterization of the punctum or punctal plugs placed within 14 days prior or during study enrollment
- Any prior ocular surgery (including refractive palpebral and cataract surgery) within 90 days of study enrollment
- History of drug addiction or alcohol abuse
- Participation in a trial with a new active substance during the past 6 months
- Participation in another trial study at the same time as the present study
- Have been exposed to any investigational drug within the preceding 30 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Richard W Yee, MD PLLC
Bellaire, Texas, 77401
832-289-2020
About this study
Official title: A Single-Center, Prospective Randomized, Double-Masked, Placebo-Controlled, Parallel- Group Pilot Study of the Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye
The objective of this study is to evaluate the clinical efficacy of topical spironolactone ophthalmic solution, 0.005 mg/cc in subjects with dry eye disease compared to placebo. The hypothesis for this study is that topical spironolactone ophthalmic solution will be beneficial in the management of signs and symptoms of dry eye disease when compared to placebo.
- Conditions
- Dry Eye Disease
- Being tested
- Topical spironolactone ophthalmic solution, 0.005 mg/cc, Placebo
- 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.
Topical spironolactone ophthalmic solution, 0.005 mg/ccDrug
Used four times a day in both eyes for 4 weeks.
PlaceboDrug
Used four times a day in both eyes for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects receive topical spironolactone ophthalmic solution, 0.005 mg/cc four times a day for 4 weeks. Receives: Drug: Topical spironolactone ophthalmic solution, 0.005 mg/cc |
| Placebo | Placebo comparator | Subjects receive topical spironolactone vehicle as placebo four times a day for 4 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to Week 4 in the Symptom Assessment Questionnaire Dry Eye (SANDE) score.
The SANDE score is calculated by taking the square root of the product of the severity of symptoms score and the frequency of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount or absence of dry eye symptoms.
Measured: Baseline to Week 4
Secondary outcomes (1)
Change from Baseline to Week 4 in the corneal fluorescein staining
Corneal fluorescein staining is measured by the 0-3 point National Eye Institute (NEI) grading scale in any one corneal region. 0 represents no staining and 3 represents maximal/severe staining and damages to the cornea. Scores from each of the five corneal regions as defined by the NEI grading scale will be evaluated independently.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard W Yee, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Richard W Yee, MD, Yee, Richard W., M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995392
- Sponsor's protocol ID
- S2023
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Prospective Randomized, Double-Masked, Placebo-Controlled, Parallel- Group Pilot Study of the Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye
- ClinicalTrials.gov ID
- NCT05995392
- Acronym / sponsor ID
- S2023
- Conditions
- Dry Eye Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Richard W Yee, MDUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the clinical efficacy of topical spironolactone ophthalmic solution, 0.005 mg/cc in subjects with dry eye disease compared to placebo. The hypothesis for this study is that topical spironolactone ophthalmic solution will be beneficial in the management of signs and symptoms of dry eye disease when compared to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Topical spironolactone ophthalmic solution, 0.005 mg/ccSubjects receive topical spironolactone ophthalmic solution, 0.005 mg/cc four times a day for 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects receive topical spironolactone vehicle as placebo four times a day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- SANDE questionnaire ≥30 mm
- Schirmer test without anesthesia ≥2 mm/5 minutes
- Corneal fluorescein staining score of ≥1 (0-3 point scale) in at least 1 corneal region of the 5 zones based on the NEI scale, with particular attention paid to the inferior region
- The same eye (eligible eye) must fulfill all the above criteria
- No lagophthalmos, entropion, ectropion
Key exclusion criteria (24 listed)
- Evidence of an active ocular infection, in either eye
- Presence of any other ocular disorder or condition requiring topical medication during the entire duration of study
- History of severe systemic allergy or of ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis and/or keratitis other than dry eye
- Intraocular inflammation defined as Tyndall score >0
- Systemic disease not stabilized within 1 month before Visit 1 (e.g. diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (e.g. current systemic infections) or incompatible with the frequent assessment required by the study
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 |
|---|---|---|
| Topical spironolactone ophthalmic solution, 0.005 mg/ccUsed four times a day in both eyes for 4 weeks. | Drug | Treatment |
| PlaceboUsed four times a day in both eyes for 4 weeks. | Drug | Placebo |
Primary outcome
Change from Baseline to Week 4 in the Symptom Assessment Questionnaire Dry Eye (SANDE) score.
Time frame: Baseline to Week 4
The SANDE score is calculated by taking the square root of the product of the severity of symptoms score and the frequency of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount or absence of dry eye symptoms.
1 secondary outcome
Change from Baseline to Week 4 in the corneal fluorescein staining
Time frame: Baseline to Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Topical spironolactone ophthalmic solution, 0.005 mg/cc in people with Dry Eye Disease, run by Richard W Yee, MD 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 14 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 21 Aug 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard W Yee, MD (7133063051, drrichardyee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline to Week 4 in the Symptom Assessment Questionnaire Dry Eye (SANDE) score. (time frame: Baseline to Week 4). 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 21 Aug 2023.