A Phase 2 interventional study of Latanoprost and Timolol in Glaucoma, sponsored by University of Nebraska. Terminated at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by University of Nebraska · Phase 2, Interventional, and Treatment
The primary purpose of this study is to show, through a controlled masked clinical study of subjects with ocular hypertension (OHT), that latanoprost increases the low uveoscleral drainage of aqueous humor back to normal levels, and timolol maleate reduces the formation of aqueous humor below normal. Both of these mechanisms will effectively reduce intraocular pressure (IOP).
The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility, and episcleral venous pressure and on all parameters over time.
A recent publication by our laboratory has shown that patients with ocular hypertension (OHT) have reduced uveoscleral outflow and reduced trabecular outflow facility compared with healthy age-matched controls. These changes are the cause of the elevated intraocular pressure (IOP). Aqueous flow rate did not change in these patients. It is logical to assume that it would be more efficacious to treat OHT patients with drugs that reduce IOP by increasing uveoscleral outflow (which is abnormally low) than with drugs that reduce aqueous flow (which is normal in OHT).
The primary purpose of this study is to show, through a controlled masked clinical study of OHT patients, that latanoprost increases the low uveoscleral drainage of aqueous humor (Fu) back to normal levels, and timolol maleate reduces the formation of aqueous humor (Fa) below normal. Both of these mechanisms will effectively reduce IOP.
The secondary purpose is to assess the effects of both latanoprost and timolol maleate on the fluorophotometric outflow facility (Cflu), and episcleral venous pressure (Pev) and on all parameters over time.
Subjects eligible to participate will be at least 19 years of age and diagnosed with bilateral ocular hypertension or primary open angle glaucoma and have intraocular pressure between 20 and 35 mmHg in both eyes on Day 0. Subjects will be treated with either latanoprost or timolol for 6 weeks and then crossover and be treated similarly with the alternate drug for an additional 6 weeks. There will be a screening visit and a total of 6 study visits in which aqueous humor flow, uveoscleral outflow, and fluorophotometric outflow facility will be determined using an instrument called a fluorophotometer. The fluorophotometer scans the eye for fluorescein dye allowing the investigator to measure and calculate the above variables. There will be 7 scans taken during each study day and additionally IOP will be measured after the completion of each scan. An Exit exam will be performed at the time of exit to ensure the ocular health of the subject.
Subjects will be monitored for adverse events throughout the course of the study and subjects may discontinue from the study at any time for any reason, or may be discontinued if, in the opinion of the investigator, there is a risk to the subject.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 30 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
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Exclusion Criteria:
Systemic Conditions:
Ocular Conditions:
Women:
Evaluating the Effects of Latanoprost on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue)
Drug: Latanoprost
Evaluating the Effects of Timolol on Aqueous Humor Dynamics in Ocular Hypertensive Patients (prostaglandin analogue)
Drug: Timolol
dosage form:eye drops, dosage: One drop in each eye twice a day
dosage form:eye drops, dosage: One drop in each eye twice a day
Comparison of Latanoprost and Timolol in lowering ocular pressure
Two drugs, Latanoprost and Timolol, will be compared in ocular hypertensive patients in their ability to lower ocular pressure at six months using a Goldmann applanation tonometer (GAT).
Time frame: 6 months
This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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University of Nebraska