Treating Contact Lens Discomfort With Orthokeratology

NCT03566680 | Completed Results FDA Device

• 1 other identifier: OAN 000520524
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Contact Lens Complication

Outcome Measures

Primary Outcomes (1)

• 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.

  1 Month Compared to Baseline

Secondary Outcomes (5)

• Contact Lens Comfort

  1 Week Compared to Baseline

• Contact Lens Comfort

  3 Month Compared to Baseline

• Non-Invasive Tear Break-Up Time

  1 Month Compared to Baseline

• Tear Meniscus Height

  1 Month Compared to Baseline

• Phenol Red Thread

  1 Month Compared to Baseline

Study Arms (1)

Orthokeratology Group

EXPERIMENTAL

All subjects will be fit in orthokeratology contact lenses.

Device: Orthokeratology

Interventions

Orthokeratology DEVICE

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.

Orthokeratology Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 32097182 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Andrew Pucker
• Organization: The University of Alabama at Birmingham

apucker@uab.edu

920-579-2900

Study Officials

• Andrew D Pucker, OD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All subjects will be fit in orthokeratology contact lenses and be monitored for three months.

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 25, 2018
• Study Start: August 7, 2018
• Primary Completion: April 15, 2019
• Study Completion: June 15, 2019
• Last Updated: August 17, 2020
• Results First Posted: May 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)