Treating Contact Lens Discomfort With Orthokeratology

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT03566680
• Collaborator: (none)
• Enrollment: 46
• Location: 1
• Arm: 1
• Actual Duration (Months): 10.3
• Patients Per Site Per Month: 4.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye; Contact Lens Complication	Device: Orthokeratology	N/A

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

• Study Type: Interventional
• Actual Enrollment: 46 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All subjects will be fit in orthokeratology contact lenses and be monitored for three months.All subjects will be fit in orthokeratology contact lenses and be monitored for three months.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treating Contact Lens Discomfort With Orthokeratology
• Actual Study Start Date: Aug 7, 2018
• Actual Primary Completion Date: Apr 15, 2019
• Actual Study Completion Date: Jun 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Orthokeratology Group All subjects will be fit in orthokeratology contact lenses.	Device: Orthokeratology; 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.

Outcome Measures

Primary Outcome Measures

1. Contact Lens Comfort [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.

Secondary Outcome Measures

1. Contact Lens Comfort [1 Week Compared to Baseline]

   Contact lens comfort was measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).

2. Contact Lens Comfort [3 Month Compared to Baseline]

   Eye comfort will be measured with the Contact Lens Dry Eye Questionnaire-4 (Range = 0 to 18 with lower scores being better).

3. Non-Invasive Tear Break-Up Time [1 Month Compared to Baseline]

   This is a measure of tear stability (Measured in seconds with higher amounts of time being better).

4. Tear Meniscus Height [1 Month Compared to Baseline]

   This is a measure of tear volume (Measured in millimeters with higher heights being better).

5. Phenol Red Thread [1 Month Compared to Baseline]

   This is a measure of tear volume (Range = 0 to 75 millimeters with higher values being better).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233

Sponsors and Collaborators

• University of Alabama at Birmingham

Investigators

• Principal Investigator: Andrew D Pucker, OD, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Apr 1, 2020

More Information

Publications

None provided.

• Responsible Party: Andrew Pucker, Assistant Professor, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03566680
• Other Study ID Numbers: OAN 000520524
• First Posted: Jun 25, 2018
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Dry Eye Syndromes

Study Results

Participant Flow

Recruitment Details	Subjects were recruited if they were in the 18-45 had significant Contact lens dry eye questionnaire 8 (cldeq-8) scores (12 or greater), subjects also had to be previous spectacle or contact lens wearers, and had relatively healthy meidcal history, as well as being able to be fit within the approved fda range for orthok (orthokeratology) lenses.

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
Period Title: Overall Study
STARTED	46
COMPLETED	29
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: 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.
Overall Participants	46
Age (Years) [Mean (Full Range) ]
Mean (Full Range) [Years]	24.22
Sex: Female, Male (Count of Participants)
Female	34 73.9%
Male	12 26.1%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Number) [Number]
United States	46 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Participants recruited for this study were required to be within the age ranges of 18-45 with good overall health. Subjects were required to need vision correction, and willing to come in for multiple in person visits during the first month of enrollment.

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
Measure Participants	29
Baseline	22.03 (5.47)
1 Month	9.83 (5.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Orthokeratology Group
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
Measure Participants	29
Baseline	11.72 (2.59)
1 week	7.44 (3.55)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Orthokeratology Group
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
Measure Participants	29
Baseline	11.72 (2.59)
3 months	4.27 (3.52)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Orthokeratology Group
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
Measure Participants	29
Baseline	12.25 (6.28)
1 month	12.60 (5.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Orthokeratology Group
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	0.73
	Comments
	Method	t-test, 2 sided
	Comments

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
Measure Participants	29
Baseline	0.27 (0.09)
1 Month	0.26 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Orthokeratology Group
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
Measure Participants	29
Baseline	25.75 (9.19)
1 Month	27.67 (8.57)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Orthokeratology Group
	Comments
	Type of Statistical Test	Equivalence
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	Subjects were required to come in for four in person visits over the course of the first month of this study. However an email containing a survey was sent out after 3 months prior to the subject being exited from the study. During this time subjects were encouraged to contact the Pucker laboratory directly regarding any issues or questions they had about their orthok lenses or their general vision.
Arm/Group Title	Orthokeratology Group
Arm/Group Description	All subjects will be fit in orthokeratology contact lenses. Orthokeratology: Orthokeratology lenses are a type of lens that can be worn overnight while a patient is sleeping, during this time the cornea is reshaped by the lens thus reducing the refractive error. This allows subjects to have corrected vision during the day, this would prevent the need of wearing contact lenses or glasses throughout the course of the day.
All Cause Mortality
	Orthokeratology Group
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Serious Adverse Events
	Orthokeratology Group
	Affected / at Risk (%)	# Events
Total	0/46 (0%)
Other (Not Including Serious) Adverse Events
	Orthokeratology Group
	Affected / at Risk (%)	# Events
Total	0/46 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.