Recruiting
Early Phase 1

Ocular Hygiene

Sponsor:

University of Houston

Code:

NCT03544385

Conditions

Scleral Contact Lenses

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Ringers Solution

Placebo - Concentrate

Study Details

Brief summary:

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.

Conditions

Scleral Contact Lenses

Study ID

NCT03544385

Start date

May 18, 2018

Status verified date

May, 2018

Completion date

Oct 25, 2018

Anticipated

Primary completion date

Jul 25, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Treatment Group

placebo comparator: Placebo Group

Interventions

Ringers Solution

Treatment vs Placebo

Placebo - Concentrate

treatment vs placebo

Primary outcome measure

  • length of scleral lens wear [ Time Frame: one month ]

Central Contacts and Locations

Central contacts

Amy Conner, OD

713-743-7636abconne2@central.uh.edu

Locations

University of Houston- College of Optometry

Recruiting

Houston, Texas, United States, 77204

Principal Investigator:

Jan Bergmanson, OD

More Information

Sponsor

University of Houston

Last update posted

Jun 1, 2018

Last verified

May, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Houston on 2018-06-01.