Clinical trial NCT02030886: IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients
Official title: A Single-center, Open Label, Prospective Study Assessing the 24-hour IOP Patterns Using SENSIMED Triggerfish® in Ocular Hypertensive Patients Newly Converted to Glaucomatous Disease Versus Stable Ocular Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ocular Hypertension
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2014-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to assess the relationship between IOP pattern as recorded over 24 hours by using Triggerfish and quantified by acrophase scored dichotomously, and conversion to glaucoma in OHT patients (conversion status). Elevation of IOP above normal range is called "ocular hypertension" (OHT). In a previous study, it has been shown that OHT patients who progress to glaucoma (converters) have at baseline and prior to any conversion, IOP patterns that more closely resemble those of established early primary open-angle glaucoma (POAG) patients, while stable OHT patients (non-converters) have IOP patterns closer to those of healthy control subjects. The study has been planned to recruit at least 48 eligible patients (24 converters and 24 non-converters).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of OHT (IOP \>21 mmHg on 2 consecutive visits) in the study eye
* No IOP-lowering drug treatment in the study eye; otherwise, a 4-week wash-out period prior to study day 0 (SD0) and throughout the study
* Aged ≥ 18 years, of either sex
* Not more than 6 diopters spherical equivalent in the study eye
* Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Narrow iridocorneal angle or any other concomitant ocular conditions (except cataract) in the study eye
* History of ocular surgery on the study eye (except cataract extraction)
* History of laser treatment on the study eye
* Corneal or conjunctival abnormality in the study eye, precluding contact lens adaptation
* Severe dry eye syndrome
* Subjects with irregular sleep schedules
* Subjects who are current smokers
* Subjects with allergy to corneal anesthetic
* Subjects with contraindications for silicone contact lens wear
* Subjects not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
* Any other contra-indication listed in the TF user manual

Primary outcomes:
measure: Relationship Between Intraocular Pressure (IOP) Pattern as Recorded by TF, and Quantified by Acrophase Scored Dichotomously, and Conversion to Glaucoma in Ocular Hypertension (OHT) Patients (Conversion Status)
timeFrame: 24 hours
Secondary outcomes:
measure: Acrophase Scored Continuously (i.e. Actual Time of TF Peak Occurrence)
timeFrame: 24 hours
measure: Amplitude of Best-fitting Cosine Curve to 24-hour TF Measurements
timeFrame: 24 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Medical School
state: Connecticut
Study officials:
affiliation: Yale University
name: Ji Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: