IOP Patterns in Ocular Hypertensive Patients Newly Converted to Glaucoma vs Stable Ocular Hypertensive Patients

Sensimed

Status: Terminated

Conditions: Ocular Hypertension

Treatments: Device: Sensimed Triggersfish® (TF)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02030886

TF-1302

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Ocular hypertension subjects

Other group

Description:

All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.

Treatment:

Device: Sensimed Triggersfish® (TF)