NCT00455455

Corneal and Conjunctival Sensitivity and Staining Study

Completed Phase 4 Results posted Last updated 9 June 2010

What this trial tests

Phase 4 trial testing Optifree RepleniSH Multipurpose Disinfecting Solution in Myopia in 50 participants. Completed in 1 December 2008.

Timeline

1 March 2007

Primary endpoint
1 December 2008

1 December 2008

Quick facts

Lead sponsor	University of Waterloo
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	1 March 2007
Primary completion	1 December 2008
Estimated completion	1 December 2008
Sites	1 location across Canada

Drugs / interventions tested

• Optifree RepleniSH Multipurpose Disinfecting Solution — full drug profile →
• ReNu Multiplus Multipurpose Solution

Conditions studied

• Myopia — all drugs for Myopia →
• Hyperopia — all drugs for Hyperopia →

Sponsor

University of Waterloo

Who can join

Adults 17 to 45, any sex, with Myopia or Hyperopia. Healthy volunteers can join.

What's being measured

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

• Corneal Sensitivity
  Time frame: baseline
  The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
• Corneal Sensitivity
  Time frame: day 7
  The detection threshold, the lowest level at which a stimulus to the cornea in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
• Conjunctival Sensitivity
  Time frame: baseline
  The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.
• Conjunctival Sensitivity
  Time frame: day 7
  The detection threshold, the lowest level at which a stimulus to the conjunctiva in a unit of percent CO2 can be detected was measured. Sensitivity is the reciprocal of the detection threshold.

Sponsor's own description

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

Publications & conference data

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

1. Effects of silicone hydrogel contact lens wear on ocular surface sensitivity to tactile, pneumatic mechanical, and chemical stimulation.
   Situ P, Simpson TL, Jones LW, Fonn D. · · 2010 · cited 38× · PMID 20592230 · DOI 10.1167/iovs.09-4807