Last updated: April 4, 2023
Sponsor: Massachusetts Eye and Ear Infirmary
Overall Status: Active - Recruiting
Phase
1
Condition
Glaucoma
Ocular Hypertension
Vascular Diseases
Treatment
N/AClinical Study ID
NCT04500574
2020P001916
2020A000354
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 - 85 years of age willing and able to give informed consent and in theinvestigator's judgment able to follow the study protocol
- Ocular hypertension, primary open-angle glaucoma, pigmentary or pseudoexfoliationglaucoma, with mild to moderate glaucoma defined as Mean Deviation on Humphrey VisualField testing no worse than -10 dB
- Patients on latanoprost in the study eye with an adequate IOP control with latanoprostalone
Exclusion
Exclusion Criteria: Systemic
- Use of oral carbonic anhydrase inhibitors
- Unstable dose of oral medication during the last 30 days that in the opinion of theInvestigator may influence the IOP
- Unstable dose of oral steroid at the time of enrollment
- Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agentswithin six months before screening or anticipated use at any time during the study
- Known allergy or hypersensitivity to the study medication or its components
- Female patients who are pregnant, nursing, or planning a pregnancy, or who are ofchildbearing potential and not using a reliable means of contraception
- Participation in an investigational drug or device study within the 30 days beforescreening
- Patient has a condition or is in a situation which, in the Investigator's opinion, mayput the patient at significant risk, may confound the study results, or may interferesignificantly with the patient's participation in the study
- Any condition (including the inability to read visual acuity charts or languagebarrier) which precludes a patient's ability to comply with study requirementsincluding completion of the study Study Eye
- History of complex cataract surgery with vitreous loss
- History of cystoid macular edema or uveitis
- Corneal decompensation or edema
- Corneal thickness <500 or > 600 μm in the study eye by pachymetry
- Prior treatment-related adverse event or allergy to latanoprost
- Evidence of macular edema/intraretinal fluid on screening macula optical coherencetomography (OCT)
- Any ocular condition in the study eye that in the opinion of the investigator wouldprevent the eye from wearing a contact lens (e.g., ectropion, lid abnormality, orsymblepharon)
- Use of beta-blocker, alpha agonist, rho kinase inhibitor, or carbonic anhydraseinhibitor drops within 1 month prior to screening; the use of latanoprost must bestable for at least 4 weeks prior to screening
- Use of latanoprost for < 4 weeks prior to screening
- Use of topical steroids
- Active optic disc or retinal neovascularization in the study eye at screening
- Presence of rubeosis iridis in the study eye at screening
- History of herpetic infection in the study eye or adnexa
- Media opacity in the study eye at screening that precludes clinical and photographicevaluation (including but not limited to preretinal or vitreous hemorrhage, lensopacity)
- Intraocular surgery, including cataract surgery, and/or laser of any type in the studyeye within 30 days prior to screening
- History of kerato-refractive surgery
- Any prior filtering surgery, including trabeculectomy, glaucoma drainage device, orXen implant
- Inability to comfortably wear a commercial contact lens (C-CL) that has the samedimensions as the L-CL during the week-long run-in period Both Eyes: any active ocular infection (i.e., bacterial, viral, parasitic, or fungal) ineither eye at screening Non-study Eye: Pinhole score < 19 letters (at least 20/400 Snellen equivalent) in thenon-study eye at the screening visit
Study Design
Total Participants: 31
Study Start date:
April 03, 2023
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
Massachusetts Eye and Ear
Boston, Massachusetts 02114
United StatesActive - Recruiting
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