Effect of Ocular Hygiene on Scleral Lens Wear

This is a study to evaluate the performance of Lid Scrubs when added to the daily regimen of scleral lens wear. Lid Scrubs contain surfactants and chemically developed Ringer's solution with microbial attributes. Lid Scrubs are typically used in the treatment of blepharitis. This study is geared towards showing added benefits to scleral lens patients when adding Lid Scrubs to their daily regimens. This study will also show if Lid Scrubs are capable of antimicrobial properties on scleral lens accessories.

Study Overview

• Status: Unknown
• Conditions: Scleral Contact Lenses
• Intervention / Treatment: Drug: Ringers Solution; Drug: Placebo - Concentrate

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • Recruiting
      • University of Houston- College of Optometry
      • Contact: Amy Conner, OD
      • Principal Investigator: Jan Bergmanson, OD
      • Sub-Investigator: Amy Conner, OD
      • Sub-Investigator: Maria Walker, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Age: 18 years old to - 85 years old Scleral Lens Correction criteria: Patients should be habitual scleral lens wearers. Patients should use scleral lenses for at least 8 hours a day and for at least 5 days of the week

Exclusion Criteria:

• Exclusions to participate in the study include: adults unable to consent, age restrictions, pregnant women, prisoners, non-english speaking patients (as consent forms are only available in the English language), current optometry students and faculty as these patients may be biased to which products they are using.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group	Drug: Placebo - Concentrate; treatment vs placebo
Experimental: Treatment Group	Drug: Ringers Solution; Treatment vs Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
length of scleral lens wear	one month

Collaborators and Investigators

• Sponsor: University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Anticipated): July 25, 2018
• Study Completion (Anticipated): October 25, 2018

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00000851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No