NCT01961193: COMLENPLSTAN

A Comparison Between Bandage Contact Lens, Punctal Plugs and Standard Measures in Preventing Corneal Injuries Related to Exposure in Patients Admitted to the General Intensive Care Unit.

Status unknown NA Last updated 10 October 2013

What this trial tests

NA trial testing contact lens in Contact Lens and Punctal Plug in Preventing Corneal Injuries in 105 participants. Status unknown.

Timeline

1 May 2015

Primary endpoint
1 July 2015

1 July 2015

Quick facts

Lead sponsor	Rabin Medical Center
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	105
Start date	1 May 2015
Primary completion	1 July 2015
Estimated completion	1 July 2015
Sites	1 location across Israel

Drugs / interventions tested

• contact lens
• punctal plug

Conditions studied

• Contact Lens and Punctal Plug in Preventing Corneal Injuries — all drugs for Contact Lens and Punctal Plug in Preventing Corneal Injuries →

Sponsor

Rabin Medical Center

Who can join

18 and older, any sex, with Contact Lens and Punctal Plug in Preventing Corneal Injuries. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Presence or absence of corneal damage
  Time frame: From date of randomization until date of dischrage from ICU or date of death from any cause whichever came first assessed up to 2 months.
  To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.

Sponsor's own description

Study Rationale:

The insertion of a bandage contact lens or punctal plug in a defined group of patients admitted to the ICU may be more effective than standard care in decreasing the incidence of corneal injuries.

Study Objectives:

1. To document the effect of a contact bandage lens and punctal plug in preventing corneal injuries in critically ill patients admitted to the ICU.
2. To assess the safety of a contact bandage lens and punctal plug in critically ill patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Conjunctival microbiology cultures in sedated, ventilated patients in the intensive care unit.
   Tiosano A, Naftali Ben Haim L, Bendavid I, Cohen JD, et al · · 2022 · cited 1× · PMID 35082390 · DOI 10.1038/s41433-021-01903-5