Dry Eye Disease Clinical Trial
Official title:
Study Title: A Phase 4 Study to Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects With Dry Eye Disease
NCT number | NCT03287635 |
Other study ID # | MMT-4223 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | July 1, 2018 |
Est. completion date | March 4, 2020 |
Verified date | January 2021 |
Source | Toyos Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study Title: A Phase 4 Study to Assess the Clinical Efficacy of H.P. Acthar Gel 80 U/ml to Improve the Signs and Symptoms in Subjects with Dry Eye Disease
Status | Completed |
Enrollment | 19 |
Est. completion date | March 4, 2020 |
Est. primary completion date | February 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - At Visit 1 (Screening) individuals of either gender or race will be eligible for study participation if they 1. Provide written informed consent and HIPAA authorization prior to any study related procedures 2. Are 18 years of age or older 3. Are willing and able to follow instructions and can be present for required study visits. 4. Have documented clinical diagnosis of dry eye disease in one or both eyes. 5. Have a score of at least 40mm on the ocular discomfort scale 6. Have at least 5 spk on one or both corneas 7. Have a grade of 1 or greater in the nasal or temporal areas of one or both eyes. 8. Have normal lid anatomy. 9. Are women of child bearing potential who are not pregnant or lactating and who are either abstinent and willing to remain so for the course of the trial or have an IUD in place for at least 3 months prior and through Visit 4, barrier method with spermicide for at least 3 months prior and through Visit 4, stable hormonal contraceptive for at least 3 months prior and through Visit 4 or in a monogamous relationship with a surgically sterilized (vasectomized) partner at least 6 months prior to Visit 1 and through the course of the trial. 10. Are postmenopausal (no menstrual cycle for at least one year prior to Visit 1) or have undergone bilateral tubal ligation, hysterectomy, hysterectomy with uni or bilateral oophorectomy, or bilateral oophorectomy. Exclusion Criteria: In order for subjects to be eligible for the study 1. Have a known hypersensitivity or contraindication to the investigational product or their components. 2. Have used any of the following medications within 14 days prior to screening a. Topical or nasal vasoconstrictors 3. Subjects can be on the following medications if they have been on a stable dose for 12 weeks topical cyclosporine, topical lifitegrast and/or topical loteprednol etabonate. Tetracycline compounds, omega 3s, anticholinergics, anticonvulsants, antidepressants, retinoids, systemic immunosuppressive agents including oral corticosteroids, non-steroidals, antihistamines or mast cell stabilizers, punctal plugs, contact lens wear and glaucoma medications. 4. Subjects must be unwilling to abstain from eyelash growth medications for the duration of the trial. 5. Subjects must not have had penetrating intraocular surgery, refractive surgery or corneal transplantation, eyelid surgery within 12 weeks prior to Visit 1. 6. Subjects with a history of herpetic keratitis. 7. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments or limit compliance. |
Country | Name | City | State |
---|---|---|---|
United States | Toyos Clinic | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Toyos Clinic | Mallinckrodt |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dry Eye Comfort Questionnaire, SANDE | Subjects will be asked to subjectively rate their eye dryness at Visit 1,2 and 3. Subjects will be instructed to rate eye dryness using the scale below. The total length of the line from "no dryness" to "maximal dryness" is 100 mm. The length of the line between the "no dryness" starting point and the first point at which the subject mark crosses the line will be measured in mm. This assessment is a general assessment of the change of both eyes of dryness measure from baseline to final study visit. The measure of discomfort was for the instantaneous measurement at the time of the specific visit. | 12 weeks total. Measure is change on SANDE scale (0 is no dryness and 100mm is maximal dryness) from baseline to final value. Higher values reflect greater amounts of subjective dryness. | |
Primary | 1. Conjunctival Staining With Lissamine Green | Change in Conjunctival staining with lissamine green. | 12 weeks total. Measure is change from baseline to final, | |
Secondary | Intraocular Pressure | goldmann tonometry used by qualified technician with fluorescein staining | 12 weeks measuring change from baseline to final |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03216096 -
Assessing Safety and Efficacy of DE-089 Ophthalmic Solution in Patients With Dry Eye Disease
|
Phase 1 | |
Completed |
NCT05825599 -
PMCF Study to Evaluate Performance and Safety of "HPMC-based Eyedrops" Used to Relieve Dry Eye Symptoms
|
N/A | |
Completed |
NCT04656197 -
The Ocular Microbiome in Patients With Dry Eye Disease
|
||
Completed |
NCT05031806 -
Evaluation of the Safety, Tolerability and Efficacy of iNexin™ for the Treatment of the Signs and Symptoms Associated With Dry Eye Disease
|
Phase 1 | |
Completed |
NCT03688802 -
Efficacy of OC-01 Nasal Spray on Goblet Cell and Meibomian Gland Stimulation
|
Phase 2 | |
Completed |
NCT05213156 -
Concentration of Ofloxacin Into the Aqueous Humour of Patients With Dry Eye Disease
|
Phase 4 | |
Completed |
NCT04548427 -
Study to Evaluate the Efficacy and Safety of CKD-352
|
Phase 3 | |
Completed |
NCT06176651 -
Evaluation of Miebo (Perfluorohexyloctane) Eyedrops in Habitual Contact Lens Wearers
|
Phase 4 | |
Completed |
NCT02254265 -
Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
|
Phase 2/Phase 3 | |
Completed |
NCT00395759 -
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
|
N/A | |
Completed |
NCT00680108 -
A Study to Determine the Safety and Tolerability of Escalating Doses of INS365 Ophthalmic Solution
|
Phase 2 | |
Recruiting |
NCT06064071 -
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
|
N/A | |
Completed |
NCT04139122 -
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06375343 -
Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive®
|
Phase 1 | |
Completed |
NCT01468168 -
A Study Assessing the Safety and Efficacy of DE-101 Ophthalmic Suspension in Dry Eye Patients
|
Phase 2 | |
Completed |
NCT01014078 -
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease
|
Phase 4 | |
Completed |
NCT00799682 -
Exploratory Study Comparing Signs and Symptoms in Patients With Ocular Hypertension or Glaucoma Using Xalatan R® or Travatan Z®
|
Phase 4 | |
Completed |
NCT05082974 -
Investigator Initiated Study to Assess the Efficacy of OC-01 (Varenicline) Nasal Spray on Signs and Symptoms of Dry Eye Disease Following Laser-assisted in Situ Keratomileusis (LASIK)
|
Phase 3 | |
Recruiting |
NCT06146881 -
Effectiveness of Diquafosol Prophylactic Therapy to Prevent Dry Eye Disease for Cataract Surgery Patients in Indonesia
|
Phase 2 | |
Completed |
NCT03292809 -
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
|
Phase 2/Phase 3 |