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Treating Contact Lens Discomfort With Orthokeratology

Primary Purpose

Dry Eye, Contact Lens Complication

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Orthokeratology
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • A completed comprehensive eye exam within the past two years
  • Contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months
  • Able to wear the Emerald™ Contact Lens (Oprifocon A, Euclid Systems Corporation)
  • Refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder
  • Keratometry values between 40.00 D and 46.00 D

Exclusion Criteria:

  • Past orthokeratology use
  • Ocular surgery within the past 12 months
  • History of severe ocular trauma
  • Active ocular infection or inflammation
  • Ocular disease other than dry eye
  • Accutane or ocular medication use
  • Pregnant or breast feeding
  • A condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Orthokeratology Group

Arm Description

All subjects will be fit in orthokeratology contact lenses.

Outcomes

Primary Outcome Measures

Contact Lens Comfort
Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-8 (Range = 0 to 28 with lower scores being better). Subjects were required to have Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores of 12 or greater in order to participate in this study.

Secondary Outcome Measures

Contact Lens Comfort
Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).
Contact Lens Comfort
Eye comfort will be measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).
Non-Invasive Tear Break-Up Time
This is a measure of tear stability (Measured in seconds with higher amounts of time being better).
Tear Meniscus Height
This is a measure of tear volume (Measured in millimeters with higher heights being better).
Phenol Red Thread
This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better).

Full Information

First Posted
June 11, 2018
Last Updated
August 13, 2020
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03566680
Brief Title
Treating Contact Lens Discomfort With Orthokeratology
Official Title
Treating Contact Lens Discomfort With Orthokeratology
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
June 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this study is to understand if orthokeratology can be used to improve contact lens comfort and the secondary aim is understand patient adaptation to orthokeratology.
Detailed Description
Orthokeratology has yet to be fully explored for the treatment of contact lens discomfort (CLD), though some support for this practice exists in the literature. Carracedo et al., Lipson et al., and Garcia-Porta et al. found that orthokeratology resulted in better ocular comfort than soft contact lenses. Nevertheless, all three studies excluded subjects who had been diagnosed with dry eye and all three studies used symptoms surveys that were not specific to assessing CLD. Garcia-Porta et al.'s study was also limited by including both neophytes and established contact lens wearers. Yet, these studies overall suggest that orthokeratology could be used as a treatment for CLD, and one case report has even found that orthokeratology is a viable option for treating contact lens intolerance. To date, there has yet to be a study fully investigating orthokeratology as an alternative to soft contact lens use in patients with CLD. Therefore, the purpose of this study is to formally investigate if orthokeratology is a good alternative to soft contact lenses for patients who are experiencing CLD or for patients who have dropped out of contact lenses because of CLD. This study will also simultaneously evaluate the neophyte orthokeratology wearing experience with hopes of finding additional means for improving contact lens comfort. Knowing the success of orthokeratology in wearers with CLD will allow practitioners to better help and prescribe for those who may have experienced or at risk for experiencing CLD. It may also be a way to allow patients additional years of contact lens wear.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Contact Lens Complication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Orthokeratology Group
Arm Type
Experimental
Arm Description
All subjects will be fit in orthokeratology contact lenses.
Intervention Type
Device
Intervention Name(s)
Orthokeratology
Intervention Description
Orthokeratology is a type of contact lens that is worn over night to reduce refractive error, so patients do not need to wear vision correction during the day.
Primary Outcome Measure Information:
Title
Contact Lens Comfort
Description
Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-8 (Range = 0 to 28 with lower scores being better). Subjects were required to have Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) scores of 12 or greater in order to participate in this study.
Time Frame
1 Month Compared to Baseline
Secondary Outcome Measure Information:
Title
Contact Lens Comfort
Description
Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).
Time Frame
1 Week Compared to Baseline
Title
Contact Lens Comfort
Description
Eye comfort will be measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).
Time Frame
3 Month Compared to Baseline
Title
Non-Invasive Tear Break-Up Time
Description
This is a measure of tear stability (Measured in seconds with higher amounts of time being better).
Time Frame
1 Month Compared to Baseline
Title
Tear Meniscus Height
Description
This is a measure of tear volume (Measured in millimeters with higher heights being better).
Time Frame
1 Month Compared to Baseline
Title
Phenol Red Thread
Description
This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better).
Time Frame
1 Month Compared to Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A completed comprehensive eye exam within the past two years Contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months Able to wear the Emerald™ Contact Lens (Oprifocon A, Euclid Systems Corporation) Refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder Keratometry values between 40.00 D and 46.00 D Exclusion Criteria: Past orthokeratology use Ocular surgery within the past 12 months History of severe ocular trauma Active ocular infection or inflammation Ocular disease other than dry eye Accutane or ocular medication use Pregnant or breast feeding A condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Pucker, OD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be shared in aggregate as a published manuscript.
Citations:
PubMed Identifier
32097182
Citation
Duong K, McGwin G Jr, Franklin QX, Cox J, Pucker AD. Treating Uncomfortable Contact Lens Wear With Orthokeratology. Eye Contact Lens. 2021 Feb 1;47(2):74-80. doi: 10.1097/ICL.0000000000000690.
Results Reference
derived

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Treating Contact Lens Discomfort With Orthokeratology

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