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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05891106
Other study ID # CLD265-P002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 28, 2023
Est. completion date July 10, 2023

Study information

Verified date July 2023
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will be used to support assessment of AIR OPTIX® NIGHT & DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.


Description:

In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date July 10, 2023
Est. primary completion date July 10, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Key Inclusion Criteria: - Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as a therapeutic contact lens was placed on one or both eye(s) at Baseline. - Baseline and Follow-up (up to 1 year from Baseline) charts available. - Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: - Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic contact lens wear or confounds study results during the data collection period, as determined or known by the Investigator. - Used systemic or ocular medication that would confound study results during the data collection period, as determined or known by the Investigator. - Other protocol-defined exclusion criteria may apply.

Study Design


Intervention

Device:
Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses

Locations

Country Name City State
United States Franklin Park Eye Center PC Franklin Park Illinois
United States Optometry Group, PLLC Memphis Tennessee
United States Vision Health Institute Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in corneal pain at the Follow-up Visit The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits. Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)
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