SENSIMED Triggerfish Safety and Tolerability

NCT01319617 | Completed Results

• 1 other identifier: 10/05
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• Ocular Discomfort

  Ocular discomfort in the study eye is reported by patients on a 100-mm visual analog scale (left end 0 mm, no discomfort; right end 100 mm, very severe discomfort) as the distance from the left end to the patient's mark after wearing the device for 24 hours at two occasions separated by one week. Values for both sessions were averaged.

  After 24 hours of device wear

Study Arms (1)

SENSIMED Triggerfish

EXPERIMENTAL

Device: SENSIMED Triggerfish

Interventions

SENSIMED Triggerfish DEVICE

Soft contact lens-based device intended for continuous recording of relative changes in IOP

SENSIMED Triggerfish

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\<0.05 or a glaucoma Hemifield test "outside normal limits
• Glaucoma suspect, with suspicious optic disc appearance (as determined by subjective assessment on the baseline visit) or elevated IOP (\>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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sensimed AG: lead

Study Sites (1)

University of California San Diego

San Diego, California, 92093-0946, United States

Location

Related Publications (3)

• Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/jamaophthalmol.2013.1350.

  PMID: 23229696 DERIVED

• Mansouri K, Liu JH, Weinreb RN, Tafreshi A, Medeiros FA. Analysis of continuous 24-hour intraocular pressure patterns in glaucoma. Invest Ophthalmol Vis Sci. 2012 Dec 13;53(13):8050-6. doi: 10.1167/iovs.12-10569.

  PMID: 23139273 DERIVED

• Mansouri K, Medeiros FA, Tafreshi A, Weinreb RN. Continuous 24-hour monitoring of intraocular pressure patterns with a contact lens sensor: safety, tolerability, and reproducibility in patients with glaucoma. Arch Ophthalmol. 2012 Dec;130(12):1534-9. doi: 10.1001/archophthalmol.2012.2280.

  PMID: 22892888 DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Results Point of Contact

• Title: Felipe Medeiros
• Organization: UCSD

fmedeiros@glaucoma.ucsd.edu

858 82245-92

Study Officials

• Felipe Medeiros, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2011
• First Posted: March 21, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 9, 2013
• Results First Posted: September 9, 2013

Record last verified: 2013-09

Locations

US (1)