Effect of Ocular Hygiene on Scleral Lens Wear

University of Houston

Status and phase: Unknown; Early Phase 1

Conditions: Scleral Contact Lenses

Treatments: Drug: Ringers Solution; Drug: Placebo - Concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03544385

STUDY00000851

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Treatment:

Drug: Ringers Solution

Placebo Group

Placebo Comparator group

Treatment:

Drug: Placebo - Concentrate