N/A
N=41
SENSIMED Triggerfish Safety and Tolerability
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT01319617 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Sep 2013
Primary outcome: Primary: Ocular Discomfort — 25.5 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SENSIMED Triggerfish (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sensimed AG
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Discomfort |
25.5 | — |
Summary
The purpose of this investigation is to study the safety and tolerability of SENSIMED Triggerfish, a soft contact lens-based device intended to continuously record relative changes in intraocular pressure (IOP). The investigation enrols glaucoma patients and glaucoma suspects. All subjects receive two 24-hour recording sessions with the device in an ambulatory setting and at weekly interval. The level of discomfort in the study eye after 24 hours and side effects are the main endpoints of the investigation.
Eligibility Criteria
Inclusion Criteria
- Subject is able to comply with the study procedures
- Subject is 18-80 years old
- Glaucoma patient, with glaucomatous optic neuropathy based on clinical assessment of stereoscopic optic disc photographs and/or repeatable abnormal standard automated perimetry (SAP) visual fields at baseline, defined as a pattern standard deviation with P 21 mmHg) but normal and reliable SAP visual fields at baseline
- Subject has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
- Visual acuity of 20/200 or better in the study eye
- Ability of subject to understand the character and individual consequences of the study
- For women with childbearing potential, adequate contraception
Exclusion Criteria
- Subjects with contraindications for wearing contact lenses
- Severe dry eye syndrome
- Keratoconus or other corneal abnormality
- Conjunctival or intraocular inflammation
- Eye surgery prior to and throughout the study, except prior uncomplicated cataract surgery a minimum of 3 months prior to the investigation
- Full frame metal glasses during SENSIMED Triggerfish® recording
- Known hypersensitivity to silicone, plaster or ocular anesthesia
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
Data sourced from ClinicalTrials.gov (NCT01319617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.