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Status unknownNCT03544385Updated Jun 1, 2018

Effect of Ocular Hygiene on Scleral Lens Wear

An Early Phase 1 interventional study of Ringers Solution and Placebo - Concentrate in Scleral Contact Lenses, sponsored by University of Houston. Status unknown at 1 site in United States. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-01.

Sponsored by University of Houston · Early Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

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Conditions studied

  • Scleral Contact Lenses
03

In context

Lead sponsor

University of Houston is the lead sponsor of 101 studies on the registry; 17 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
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Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Treatment Group

    Drug: Ringers Solution

  • Placebo comparator
    Placebo Group

    Drug: Placebo - Concentrate

Interventions

  • DrugRingers Solution

    Treatment vs Placebo

  • DrugPlacebo - Concentrate

    treatment vs placebo

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What researchers measure

Primary outcomes

  1. length of scleral lens wear

    Time frame: one month

07

Study locations

1 of 1 sites recruiting
  • University of Houston- College of Optometry
    Houston, Texas 77204, United States
    • Amy Conner, OD · Contact
    • Jan Bergmanson, OD · Principal investigator
    • Amy Conner, OD · Sub investigator
    • Maria Walker, OD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03544385
Lead sponsor
University of Houston
Responsible party
Amy B. Conner (Resident, Optometry, University of Houston) — Principal investigator
First posted
Jun 1, 2018
Start date
May 18, 2018
Primary completion
Jul 25, 2018 (estimated)
Completion
Oct 25, 2018 (estimated)
Last update
Jun 1, 2018

Study contacts

Amy Conner, OD
Contact
abconne2@central.uh.edu
713-743-7636

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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