The Effects and Safety of Topical Spironolactone Ophthalmic Solution, 0.005 mg/cc in Subjects With Dry Eye Disease

NCT05995392 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: S2023
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 of dry eye disease when compared to placebo.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 4

Secondary Outcomes (1)

• Change from Baseline to Week 4 in the corneal fluorescein staining

  Baseline to Week 4

Other Outcomes (8)

• Change from Baseline to Week 4 in SANDE severity sub-score (0-100 point VAS)

  Baseline to Week 4

• Change from Baseline to Week 4 in SANDE frequency sub-score (0-100 point VAS)

  Baseline to Week 4

• Change from Baseline to Week 4 in conjunctival lissamine green staining

  Baseline to Week 4

Study Arms (2)

Treatment

EXPERIMENTAL

Subjects receive topical spironolactone ophthalmic solution, 0.005 mg/cc four times a day for 4 weeks.

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.

Drug: Placebo

Interventions

Topical spironolactone ophthalmic solution, 0.005 mg/cc DRUG

Used four times a day in both eyes for 4 weeks.

Treatment

Placebo DRUG

Used four times a day in both eyes for 4 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Richard W Yee, MD: lead

Study Sites (1)

Richard W Yee, MD PLLC

Bellaire, Texas, 77401, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

Richard W Yee, MD

CONTACT

7133063051; drrichardyee@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: August 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 21, 2023

Record last verified: 2023-08

Locations

US (1)