Clinical Trials Logo
  1. Home
  2. Healthy Volunteers
  3. NCT01972997
  4. Details
NCT01972997 Clinical Trial

SENSIMED Triggerfish Sensor Sizes

Healthy Volunteers Clinical Trial

Official title:
A Single-center, Randomized, Double-blinded, Prospective Study to Assess the Changes in the 24-hour IOP (Intraocular Pressure) Pattern in Relation to SENSIMED Triggerfish® Sensor Sizes in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01972997
Other study ID # TF-1220
Secondary ID
Status Completed
Phase Phase 4
First received July 26, 2013
Last updated November 16, 2015
Start date July 2013
Est. completion date March 2014

Study information
Verified date November 2015
Source Sensimed AG
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial Summary

This is a study investigating the effect of various SENSIMED Triggerfish sensor lens sizes on the recorded IOP related patterns in 10 healthy volunteers. Each volunteers receives 4 24-hours sessions of pattern recording on one selected eye (study eye). Each of the sensor lens sizes is placed on the eye in the different sessions. Subjects visit the study site for installation and removal of the device and accompanying exams, but remain ambulatory during the recording.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date March 2014
Est. primary completion date March 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Healthy subject without previous ocular disease

- Aged = 18 years, of either sex

- Central corneal radius (flat meridian) between 7.75 mm and 8.25 mm in at least one eye

- Not more than 6 diopters spherical equivalent in the study eye

- Having given written informed consent, prior to any investigational procedures

Exclusion Criteria:

- Corneal or conjunctival abnormality precluding contact lens adaptation

- Severe dry eye syndrome

- 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• SENSIMED Triggerfish

Locations
Country Name City State
Spain Hospital Clinico San Carlos Madrid

Sponsors (1)
Lead Sponsor Collaborator
Sensimed AG

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary The effect of the sensor lens size on IOP patterns as recorded by TF (SENSIMED Triggerfish) as compared to the recommended sensor lens fit 24 hours No
See also
  Status Clinical Trial Phase
Completed NCT05001152 - Taste Assessment of Ozanimod Phase 1
Completed NCT05029518 - 3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability Phase 1
Completed NCT04493255 - A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants Phase 1
Completed NCT03457649 - IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers Phase 1
Completed NCT00995891 - Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
Completed NCT05043766 - Evaluation of Oral PF614 Relative to OxyContin Phase 1
Completed NCT05050318 - Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively Phase 4
Completed NCT04466748 - A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects Phase 1
Completed NCT00746733 - Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC Phase 1
Recruiting NCT05929651 - Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy Phase 4
Completed NCT05954039 - Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect N/A
Completed NCT05045716 - A Study of Subcutaneous Lecanemab in Healthy Participants Phase 1
Active, not recruiting NCT02747927 - Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children Phase 3
Completed NCT05533801 - A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants Phase 1
Not yet recruiting NCT03931369 - Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST) Phase 2
Completed NCT03279146 - A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects Phase 1
Completed NCT06027437 - A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants Phase 1
Recruiting NCT05619874 - Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity N/A
Completed NCT05553418 - Investigational On-body Injector Clinical Study N/A
Completed NCT04092712 - Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers Phase 1