Use of an Ocular Telemetry Sensor in Diamox Treated Patients

S

Sensimed

Status

Completed

Conditions

Glaucoma
Ocular Hypertension

Treatments

Device: SENSIMED Triggerfish

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT01028664
09/05

Details and patient eligibility

About

A soft contact lens integrating a Sensor is placed on subjects with high intraocular pressure (IOP) after administration of an IOP-lowering drug to investigate the device's capacity to detect the induced IOP reduction.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of glaucoma or ocular hypertension
  • IOP of ≥ 15 mmHg.
  • Patients of either gender.
  • Older than 18 years.
  • Patients who accept signing an informed consent approved by the Ethics Committee.

Exclusion criteria

  • Patients not able to understand the nature of the research
  • Patients under tutorship
  • Corneal abnormalities in both eyes
  • Subjects with contraindications for wearing contact lenses
  • History of ocular surgery within the last 3 months
  • Known hypersensitivity to Diamox® or to any of its excipients
  • Pregnancy and lactation
  • Simultaneous participation in other clinical research
  • Patients with evidence of ocular infection or inflammation
  • History of renal or hepatic impairment, hypokalemia and hyponatremia

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Glaucoma or ocular hypertension patients
Experimental group
Treatment:
Device: SENSIMED Triggerfish

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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