Trial Outcomes & Findings for Ocular Effects of Scleral Lens Wear on Dry Eye Patients (NCT NCT05079321)

NCT ID: NCT05079321

Last Updated: 2025-05-06

Results Overview

Mean corneal thickness as measured with Pentacam HR (µm)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: At screening
• Results posted on: 2025-05-06

Participant Flow

Participants were recruited at a single site between April 2022 and October 2022. The first participant was enrolled on April 14, 2022 and the last participant was enrolled on October 25, 2022.

Of 30 enrolled participants, 28 met inclusion criteria and 25 were randomized to treatment.

Participant milestones

Measure	Coated/Uncoated Scleral Lens Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Overall Study STARTED	12	13
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Coated/Uncoated Scleral Lens Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Overall Study Withdrawal by Subject	2	2
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Ocular Effects of Scleral Lens Wear on Dry Eye Patients

Baseline characteristics by cohort

Measure	Overall Group n=28 Participants All suitable participants eligible to take part in the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.79 years STANDARD_DEVIATION 7.61 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	12 Participants n=5 Participants
Race/Ethnicity, Customized Race · Caucasian	8 Participants n=5 Participants
Race/Ethnicity, Customized Race · African/Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Indian	4 Participants n=5 Participants
Race/Ethnicity, Customized Race · Arab	2 Participants n=5 Participants
Region of Enrollment Canada	28 participants n=5 Participants

PRIMARY outcome

Timeframe: At screening

Mean corneal thickness as measured with Pentacam HR (µm)

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=12 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=13 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Mean Corneal Thickness	570.54 microns Standard Deviation 38.97	560.73 microns Standard Deviation 31.48

PRIMARY outcome

Timeframe: After 4 weeks wear of coated lens

Mean corneal thickness as measured with Pentacam HR (µm)

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Mean Corneal Thickness	552.70 microns Standard Deviation 26.96	559.85 microns Standard Deviation 35.31

PRIMARY outcome

Timeframe: After 4 weeks wear of uncoated lens

Mean corneal thickness as measured with Pentacam HR (µm)

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Mean Corneal Thickness	556.91 microns Standard Deviation 29.83	556.87 microns Standard Deviation 29.92

PRIMARY outcome

Timeframe: After 2 weeks of wear of coated lens

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	14.10 score on a scale Standard Deviation 7.92	20.30 score on a scale Standard Deviation 5.56

PRIMARY outcome

Timeframe: After 2 weeks of wear of uncoated lens

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	19.40 score on a scale Standard Deviation 7.34	17.20 score on a scale Standard Deviation 6.55

PRIMARY outcome

Timeframe: After 4 weeks of wear of coated lens

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	13.50 score on a scale Standard Deviation 7.07	19.50 score on a scale Standard Deviation 6.64

PRIMARY outcome

Timeframe: After 4 weeks of wear of uncoated lens

The CLDEQ-8 is a validated questionnaire used to quantify symptoms experienced by the contact lenses (CLs) wearer. The participants were asked to respond to 8 questions about how their CLs performed over the preceding 2-week period. 4 questions (Eye discomfort, Eye dryness, Changeable blurry vision and Closing your eyes) answered on a scale of 0=Never to 4=Constantly; 3 questions about the end of wearing time (Discomfort, Dryness, Changeable blurry vision) answered on a scale of 0=Never have it to 5=Very Intense and 1 question (Removing your lenses) on a scale of 1=Never to 6=Several times a day for a total possible score of 1(best) to 37 (worst).

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Contact Lens Dry Eye Questionnaire (CLDEQ-8) Score	18.60 score on a scale Standard Deviation 7.99	15.10 score on a scale Standard Deviation 7.65

PRIMARY outcome

Timeframe: At screening

Tear film osmolarity measures with a Tearlab Osmolarity System

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=12 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=13 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Tear Film Osmolarity	313.29 mOsm/l Standard Deviation 22.18	309.69 mOsm/l Standard Deviation 16.32

PRIMARY outcome

Timeframe: After 4 weeks of wear of uncoated lens

Tear film osmolarity measures with a Tearlab Osmolarity System

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Tear Film Osmolarity	300.00 mOsm/l Standard Deviation 12.87	306.05 mOsm/l Standard Deviation 12.87

PRIMARY outcome

Timeframe: After 4 weeks of wear of coated lens

Tear film osmolarity measures with a Tearlab Osmolarity System

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Tear Film Osmolarity	304.40 mOsm/l Standard Deviation 8.48	303.90 mOsm/l Standard Deviation 11.57

PRIMARY outcome

Timeframe: After 4 weeks of wear of uncoated lens

This self-administered Contact Lens Impact on Quality of Life (CLIQ) questionnaire uses 28-item questions which are categorized into five main parameters: daily activities, eye symptoms, functional vision, psychometric properties, and refractive correction. Each question has a five-step response scale (none = 1; little = 2; moderate = 3; extreme = 4 and unable = 5). The responses are computed using the formula: CLIQperson measure = 34.41 × log (CLIQraw score/5 - CLIQraw score) + 26.69. This is then analyzed on a scale from 0 to 100, where higher scores indicate better QoL.

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score	37.66 score on a scale Standard Deviation 13.37	39.67 score on a scale Standard Deviation 9.78

PRIMARY outcome

Timeframe: After 4 weeks of wear of coated lens

This self-administered Contact Lens Impact on Quality of Life (CLIQ) questionnaire uses 28-item questions which are categorized into five main parameters: daily activities, eye symptoms, functional vision, psychometric properties, and refractive correction. Each question has a five-step response scale (none = 1; little = 2; moderate = 3; extreme = 4 and unable = 5). The responses are computed using the formula: CLIQperson measure = 34.41 × log (CLIQraw score/5 - CLIQraw score) + 26.69. This is then analyzed on a scale from 0 to 100, where higher scores indicate better QoL.

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Contact Lens Impact on Quality of Life (CLIQ) Questionnaire Score	40.70 score on a scale Standard Deviation 9.49	40.54 score on a scale Standard Deviation 11.31

PRIMARY outcome

Timeframe: At screening

Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=12 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=13 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	83.33 percentage of participants	84.62 percentage of participants

PRIMARY outcome

Timeframe: After 4 weeks of wear of coated lens

Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	80 percentage of participants	70 percentage of participants

PRIMARY outcome

Timeframe: After 4 weeks of wear of uncoated lens

Percentage of participants with a positive MMP-9 test, as measured by InflammaDry

Outcome measures

Measure	Coated/Uncoated Scleral Lens n=10 Participants Participants wear first wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated) Participants then wear uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated)	Uncoated/Coated Scleral Lens n=10 Participants Participants wear first uncoated (control) lenses. Uncoated: Zen™ RC scleral lenses (non-coated Participants wear then wear lenses coated with Hydra-PEG. Hydra-PEG: Zen™ RC scleral lenses (Hydra-PEG coated)
Percentage of Participants With MMP-9 Inflammatory Marker in Tear Film	50 percentage of participants	60 percentage of participants

Adverse Events

Coated Scleral Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Uncoated Scleral Lens

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

Lyndon Jones

Centre for Ocular Research and Education

Phone: (519) 888-4567

Email: lwjones@uwaterloo.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place