Dry EyeNCT03566680
Treating Contact Lens Discomfort With Orthokeratology
A study testing Orthokeratology in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Contact Lens Complication
- What is being tested?
- Orthokeratology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
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.
Read the 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.
- Conditions
- Dry Eye, Contact Lens Complication
- Being tested
- Orthokeratology
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthokeratologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology Group | Experimental | All subjects will be fit in orthokeratology contact lenses. Receives: Device: Orthokeratology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month Compared to Baseline
Secondary outcomes (5)
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).
Measured: 1 Week Compared to Baseline
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).
Measured: 3 Month Compared to Baseline
Non-Invasive Tear Break-Up Time
This is a measure of tear stability (Measured in seconds with higher amounts of time being better).
Measured: 1 Month Compared to Baseline
Tear Meniscus Height
This is a measure of tear volume (Measured in millimeters with higher heights being better).
Measured: 1 Month Compared to Baseline
Phenol Red Thread
This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better).
Measured: 1 Month Compared to Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start7 Aug 2018
- Primary completion15 Apr 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Pucker, University of Alabama at Birmingham
- Investigators
- Andrew D Pucker, OD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566680
- Sponsor's protocol ID
- OAN 000520524
- Status last verified
- Aug 2020
- First submitted
- 11 Jun 2018
- Last updated
- 17 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The data will be shared in aggregate as a published manuscript.
Publications
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.
PubMed 32097182
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Contact Lens Discomfort With Orthokeratology
- ClinicalTrials.gov ID
- NCT03566680
- Acronym / sponsor ID
- OAN 000520524
- Conditions
- Dry Eye, Contact Lens Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Posted 5 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology Group | Experimental | Device: OrthokeratologyAll subjects will be fit in orthokeratology contact lenses. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OrthokeratologyOrthokeratology 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. | Device | Orthokeratology Group |
Primary outcome
Contact Lens Comfort
Time frame: 1 Month Compared to Baseline
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.
5 secondary outcomes
Contact Lens Comfort
Time frame: 1 Week Compared to Baseline
Contact Lens Comfort
Time frame: 3 Month Compared to Baseline
Non-Invasive Tear Break-Up Time
Time frame: 1 Month Compared to Baseline
Tear Meniscus Height
Time frame: 1 Month Compared to Baseline
Phenol Red Thread
Time frame: 1 Month Compared to Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32097182Duong 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.
- Individual participant dataSharing planned: No. The data will be shared in aggregate as a published manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew D Pucker, OD, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthokeratology in people with Dry Eye and Contact Lens Complication, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contact Lens Comfort (time frame: 1 Month Compared to Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03566680, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.