NCT05984290

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

Completed NA Results posted Last updated 24 August 2025

What this trial tests

NA trial testing orthokeratology lens in Myopia in 90 participants. Completed in 27 June 2024.

Timeline

11 July 2023

Primary endpoint
27 June 2024

27 June 2024

Quick facts

Lead sponsor	Bausch & Lomb Incorporated
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	11 July 2023
Primary completion	27 June 2024
Estimated completion	27 June 2024
Sites	6 locations across United States

Drugs / interventions tested

• orthokeratology lens

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

12 and older, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Rate of Serious Adverse Events at the Subject Level Primary · Assessed from dispensing through 3 months

Group	Value	95% CI
Safety and Effectiveness of the Arise Orthokeratology Lens	0

Percentage of Subjects Who Achieve Monocular Uncorrected Distance Visual Acuity (UDVA) of 20/40 or Better in Both Eyes Primary · 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

Group	Value	95% CI
Safety and Effectiveness of the Arise Orthokeratology Lens	42

The Rate of Serious Adverse Events at the Eye Level Primary · Assessed from dispensing through 3 months

Group	Value	95% CI
Safety and Effectiveness of the Arise Orthokeratology Lens	0

Adverse events — posted to ClinicalTrials.gov

Time frame: AE data collected over all scheduled follow-up visits approximately 3 months after study lens dispensed. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Safety and Effectiveness of the Arise Orthokeratology Lens

Serious: 0/76 (0%)

Deaths: 0/76

Other adverse events (1 terms — click to expand)

Reaction	System	Safety and Effectiveness o…
Corneal abrasion	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT05984290 adverse events section.

Sponsor's own description

The objective of this orthokeratology study is to evaluate the safety and effectiveness of the Arise Orthokeratology Lens with non-spherical posterior peripheral curves

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.