Trial Outcomes & Findings for Treating Contact Lens Discomfort With Orthokeratology (NCT NCT03566680)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

46 participants

Primary outcome timeframe

1 Month Compared to Baseline

Results posted on

2020-08-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Orthokeratology Group 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.
Overall Study STARTED	46
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Orthokeratology Group 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.
Overall Study Pregnancy	1
Overall Study Lost to Follow-up	13
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Orthokeratology Group n=46 Participants 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.
Age, Continuous	24.22 Years n=46 Participants
Sex: Female, Male Female	34 Participants n=46 Participants
Sex: Female, Male Male	12 Participants n=46 Participants
Region of Enrollment United States	46 Participants n=46 Participants

PRIMARY outcome

Timeframe: 1 Month Compared to Baseline

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Orthokeratology Group n=29 Participants 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.
Contact Lens Comfort Baseline	22.03 Units on a Scale Standard Deviation 5.47
Contact Lens Comfort 1 Month	9.83 Units on a Scale Standard Deviation 5.37

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Orthokeratology Group n=29 Participants 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.
Contact Lens Comfort Baseline	11.72 score on a scale Standard Deviation 2.59
Contact Lens Comfort 1 week	7.44 score on a scale Standard Deviation 3.55

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Orthokeratology Group n=29 Participants 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.
Contact Lens Comfort Baseline	11.72 Score on a Scale Standard Deviation 2.59
Contact Lens Comfort 3 months	4.27 Score on a Scale Standard Deviation 3.52

SECONDARY outcome

Timeframe: 1 Month Compared to Baseline

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

Outcome measures

Outcome measures
Measure	Orthokeratology Group n=29 Participants 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.
Non-Invasive Tear Break-Up Time Baseline	12.25 Seconds Standard Deviation 6.28
Non-Invasive Tear Break-Up Time 1 month	12.60 Seconds Standard Deviation 5.67

SECONDARY outcome

Timeframe: 1 Month Compared to Baseline

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

Outcome measures

Outcome measures
Measure	Orthokeratology Group n=29 Participants 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.
Tear Meniscus Height Baseline	0.27 Millimeters Standard Deviation 0.09
Tear Meniscus Height 1 Month	0.26 Millimeters Standard Deviation 0.07

SECONDARY outcome

Timeframe: 1 Month Compared to Baseline

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

Outcome measures

Outcome measures
Measure	Orthokeratology Group n=29 Participants 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.
Phenol Red Thread Baseline	25.75 Millimeters Standard Deviation 9.19
Phenol Red Thread 1 Month	27.67 Millimeters Standard Deviation 8.57

Adverse Events

Orthokeratology Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Andrew Pucker

The University of Alabama at Birmingham

Phone: 920-579-2900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place