Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density a… (NCT03931317) | Clinical Trial Compass
CompletedNot Applicable
Study Comparing the Effects of Latanoprostene Bunod and Timolol on Retinal Blood Vessel Density and Visual Acuity
United States70 participantsStarted 2018-12-03
Plain-language summary
The purpose of this research study is to compare the effect of Latanoprostene Bunod and Timolol on eye pressure and blood vessels of the back of the eye.
Who can participate
Age range40 Years – 90 Years
SexALL
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Inclusion Criteria:
* Subjects must be between 40 to 90 years of age, inclusive, on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
* Subjects must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved ICF. Only English speakers will be enrolled.
* Subjects who are able and willing to comply with all treatment and follow-up/study procedures.
* Female subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at Visit 1 (Screening) and Visit 3 (Randomization, Week 1).
* Females of childbearing potential, defined as a female who is fertile following menarche, must have a negative serum pregnancy test at screening and agree to use an acceptable method of contraception throughout their participation in the study.
Exclusion Criteria:
* Subjects participating in any drug or device clinical investigation within 30 days prior to Visit 1 (Screening) for subjects requiring a washout period, or 30 days prior to Visit 3 (Randomization, Week 1) for treatment naïve subjects.
* Subjects who anticipate participating in any other drug or device clinical investigation within the duration of this study.
* Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
* Female subjects who are pregna…
What they're measuring
1
retinal blood vessel density (peripapillary and macular)
Timeframe: Through study completion, an average of 11 to 19 weeks