Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear (EW23)

May 1, 2017 updated by: Meng C. Lin, University of California, Berkeley

Effects of Daily Irrigation on Corneal Epithelial Permeability and Adverse Events With Silicone Hydrogel Contact Lens Continuous Wear

This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 39 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spectacle prescriptions between -1.00 diopter sphere (DS) and -10.00 DS;
  • less than 0.75 diopters (D) of astigmatism;
  • free of any ocular disease or systemic disease with ocular manifestation;

Exclusion Criteria:

  • history of contact lens wear within the past year;
  • history of ocular surgery or serious injury;
  • presence of corneal scarring;
  • frequent swimming, smoking, or use of medications w/ ocular side effects;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 30-day SiH CW, No Daily Irrigation
Control group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines with no daily morning irrigation of the eyes with sterile saline solution
Device: 30-day SiH CW
30-day continuous wear of silicone hydrogel contact lenses
OTHER: 30-day SiH CW, Daily Irrigation
Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening
Device: 30-day SiH CW
30-day continuous wear of silicone hydrogel contact lenses
Drug: Daily irrigation
Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens
Other Names:
  • Unisol 4 (Alcon Laboratories, Inc., Fort Worth, TX)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal epithelial permeability (Pdc) at Baseline
Time Frame: Baseline
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses
Baseline
Corneal epithelial permeability (Pdc) Post-1-Day CW
Time Frame: Post-1-Day CW of SiH contact lenses
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW
Post-1-Day CW of SiH contact lenses
Corneal epithelial permeability (Pdc) Post-30-Day CW
Time Frame: Post-30-Day CW of SiH contact lenses
Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW
Post-30-Day CW of SiH contact lenses
Risk of adverse events
Time Frame: Post-30-day CW of SiH contact lenses
Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall
Post-30-day CW of SiH contact lenses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Berkeley

Investigators

  • Principal Investigator: Meng C Lin, OD, PhD, FAAO, University of California, Berkeley

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 15, 2012

Primary Completion (ACTUAL)

October 15, 2012

Study Completion (ACTUAL)

October 15, 2012

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (ACTUAL)

May 4, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2017

Last Update Submitted That Met QC Criteria

May 1, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UCBCRCEW23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Corneal Epithelial Permeability

Clinical Trials on 30-day SiH CW

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe