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Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

Conditions

Glaucoma Ocular Hypertension Latanoprost Drug eluting contact lens

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In this research study, we will assess the safety, tolerability, comfort, and feasibility of lowering intraocular pressure using a novel Contact Lens Drug Delivery System with latanoprost. Latanoprost is a well-studied medication and has been used to treat glaucoma for decades. Currently, latanoprost is FDA-approved to be administered to patients as eye drops, but using eye drops has challenges (having to remember to take the drop, getting the drop in the eye). This clinical trial is being done to determine the safety, tolerability, and effectiveness of using latanoprost to deliver latanoprost in a new way (through a drug-eluting contact lens). The study includes two phases. Phase A is intended to assess safety and tolerability and Phase B to assess safety and effectiveness.

Official Title

Latanoprost Eluting Contact Lens for Treating Glaucoma and Ocular Hypertension

Quick Facts

Study Start:2024-04-03

Study Completion:2025-10-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04500574

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 18 - 85 years of age willing and able to give informed consent and in the investigator's judgment able to follow the study protocol * Ocular hypertension, primary open-angle glaucoma, pigmentary or pseudoexfoliation glaucoma, with mild to moderate glaucoma defined as Mean Deviation on Humphrey Visual Field testing no worse than -10 dB * Patients on latanoprost in the study eye with an adequate IOP control with latanoprost alone	* Use of oral carbonic anhydrase inhibitors * Unstable dose of oral medication during the last 30 days that in the opinion of the Investigator may influence the IOP * Unstable dose of oral steroid at the time of enrollment * Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within 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 of childbearing potential and not using a reliable means of contraception * Participation in an investigational drug or device study within the 30 days before screening * Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study * Any condition (including the inability to read visual acuity charts or language barrier) which precludes a patient's ability to comply with study requirements including completion of the study * 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 coherence tomography (OCT) * Any ocular condition in the study eye that in the opinion of the investigator would prevent the eye from wearing a contact lens (e.g., ectropion, lid abnormality, or symblepharon) * Use of beta-blocker, alpha agonist, rho kinase inhibitor, or carbonic anhydrase inhibitor drops within 1 month prior to screening; the use of latanoprost must be stable 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 photographic evaluation (including but not limited to preretinal or vitreous hemorrhage, lens opacity) * Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 30 days prior to screening * History of kerato-refractive surgery * Any prior filtering surgery, including trabeculectomy, glaucoma drainage device, or Xen implant * Inability to comfortably wear a commercial contact lens (C-CL) that has the same dimensions as the L-CL during the week-long run-in period

Inclusion Criteria

Exclusion Criteria

* 18 - 85 years of age willing and able to give informed consent and in the investigator's judgment able to follow the study protocol
* Ocular hypertension, primary open-angle glaucoma, pigmentary or pseudoexfoliation glaucoma, with mild to moderate glaucoma defined as Mean Deviation on Humphrey Visual Field testing no worse than -10 dB
* Patients on latanoprost in the study eye with an adequate IOP control with latanoprost alone

* Use of oral carbonic anhydrase inhibitors
* Unstable dose of oral medication during the last 30 days that in the opinion of the Investigator may influence the IOP
* Unstable dose of oral steroid at the time of enrollment
* Use of immunosuppressants, immunomodulators, antimetabolites and/or alkylating agents within 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 of childbearing potential and not using a reliable means of contraception
* Participation in an investigational drug or device study within the 30 days before screening
* Patient has a condition or is in a situation which, in the Investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
* Any condition (including the inability to read visual acuity charts or language barrier) which precludes a patient's ability to comply with study requirements including completion of the study
* 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 coherence tomography (OCT)
* Any ocular condition in the study eye that in the opinion of the investigator would prevent the eye from wearing a contact lens (e.g., ectropion, lid abnormality, or symblepharon)
* Use of beta-blocker, alpha agonist, rho kinase inhibitor, or carbonic anhydrase inhibitor drops within 1 month prior to screening; the use of latanoprost must be stable 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 photographic evaluation (including but not limited to preretinal or vitreous hemorrhage, lens opacity)
* Intraocular surgery, including cataract surgery, and/or laser of any type in the study eye within 30 days prior to screening
* History of kerato-refractive surgery
* Any prior filtering surgery, including trabeculectomy, glaucoma drainage device, or Xen implant
* Inability to comfortably wear a commercial contact lens (C-CL) that has the same dimensions as the L-CL during the week-long run-in period

Contacts and Locations

Principal Investigator

David S Friedman, MD, PhD, MPH

PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear

Study Locations (Sites)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

David S Friedman, MD, PhD, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-03

Study Completion Date2025-10-10

Study Record Updates

Study Start Date2024-04-03

Study Completion Date2025-10-10

Terms related to this study

Keywords Provided by Researchers

Latanoprost
Glaucoma
Ocular Hypertension
Drug eluting contact lens

Additional Relevant MeSH Terms

Glaucoma
Ocular Hypertension