NCT03544385

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

2 months

First QC Date

May 21, 2018

Last Update Submit

May 21, 2018

Conditions

Scleral Contact Lenses

Outcome Measures

Primary Outcomes (1)

  • length of scleral lens wear

    one month

Study Arms (2)

Treatment Group

EXPERIMENTAL
Drug: Ringers Solution

Placebo Group

PLACEBO COMPARATOR
Drug: Placebo - Concentrate

Interventions

Ringers SolutionDRUG

Treatment vs Placebo

Treatment Group
Placebo - ConcentrateDRUG

treatment vs placebo

Placebo Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Houston- College of Optometry

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Interventions

Ringer's Solution

Intervention Hierarchy (Ancestors)

Isotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Amy Conner, OD

CONTACT

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

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident, Optometry

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 1, 2018

Study Start

May 18, 2018

Primary Completion

July 25, 2018

Study Completion

October 25, 2018

Last Updated

June 1, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)