Trial Outcomes & Findings for Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens (NCT NCT05984290)

NCT ID: NCT05984290

Last Updated: 2025-08-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: Assessed from dispensing through 3 months
• Results posted on: 2025-08-24

Participant Flow

Unit of analysis: Eyes

Participant milestones

Measure	Safety and Effectiveness of the Arise Orthokeratology Lens Treatment effect of overnight orthokeratology over a 3-month period orthokeratology lens: Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
Dispensing STARTED	90 180
Dispensing COMPLETED	76 152
Dispensing NOT COMPLETED	14 28
Study Treatment STARTED	76 152
Study Treatment COMPLETED	46 92
Study Treatment NOT COMPLETED	30 60

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens

Baseline characteristics by cohort

Measure	Safety and Effectiveness of the Arise Orthokeratology Lens n=76 Participants Treatment effect of overnight orthokeratology over a 3-month period orthokeratology lens: Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
Age, Continuous	29.6 years STANDARD_DEVIATION 10.72 • n=5 Participants
Sex/Gender, Customized Female	48 Participants n=5 Participants
Sex/Gender, Customized Male	28 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	9 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic and Not Latino	67 Participants n=5 Participants
Race/Ethnicity, Customized White	51 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	10 Participants n=5 Participants
Race/Ethnicity, Customized Asian	11 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or not reported	2 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed from dispensing through 3 months

Outcome measures

Measure	Safety and Effectiveness of the Arise Orthokeratology Lens n=76 Participants Treatment effect of overnight orthokeratology over a 3-month period orthokeratology lens: Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
The Rate of Serious Adverse Events at the Subject Level	0 Participants

PRIMARY outcome

Timeframe: Assessed at 3 month follow up visit

Using the high contrast distance UDVA collected at the 3-Month Follow-up Visit, subjects with non-missing Snellen VA of 20/40 or less in both eyes will be classified as "20/40 or Better". Subjects with at least one missing value at the 3-Month Follow-up Visit will not be classified and their classification value will be assigned as a missing value. The denominator for percentages will be the number of non-missing values

Outcome measures

Measure	Safety and Effectiveness of the Arise Orthokeratology Lens n=45 Participants Treatment effect of overnight orthokeratology over a 3-month period orthokeratology lens: Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
Percentage of Subjects Who Achieve Monocular Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better in Both Eyes	42 Participants

PRIMARY outcome

Timeframe: Assessed from dispensing through 3 months

Outcome measures

Measure	Safety and Effectiveness of the Arise Orthokeratology Lens n=152 Eyes Treatment effect of overnight orthokeratology over a 3-month period orthokeratology lens: Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
The Rate of Serious Adverse Events at the Eye Level	0 Eyes

Adverse Events

Safety and Effectiveness of the Arise Orthokeratology Lens

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Safety and Effectiveness of the Arise Orthokeratology Lens n=76 participants at risk Treatment effect of overnight orthokeratology over a 3-month period orthokeratology lens: Each subject will wear the study lenses in both eyes overnight for approximately 3 months.
Injury, poisoning and procedural complications Corneal abrasion	7.9% 6/76 • AE data collected over all scheduled follow-up visits approximately 3 months after study lens dispensed

Additional Information

Director, Medical Affairs, Vision Care R&D

Bausch & Lomb Incorporated

Phone: 585-413-6397

Email: marjorie.rah@bausch.com

Results disclosure agreements

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