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Air Optix® Night and Day® Aqua Therapeutic Wear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05956535
Recruitment Status : Enrolling by invitation
First Posted : July 21, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Description
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Brief Summary:
The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.

Condition or disease Intervention/treatment
Bullous Keratopathy Corneal Erosion Entropion Corneal Edema Corneal Dystrophy Device: Lotrafilcon A contact lenses Device: Balafilcon A contact lenses

Detailed Description:
In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.
Study Design
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Study Type : Observational
Estimated Enrollment : 231 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Air Optix® Night and Day® Aqua Therapeutic Wear
Actual Study Start Date : September 26, 2023
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024
Groups and Cohorts
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Group/Cohort Intervention/treatment
AONDA contact lenses
Lotrafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.
 Device: Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
Other Names:
  • Air Optix® Night and Day® Aqua
  • AONDA
PV2 contact lenses
Balafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.
 Device: Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
Other Names:
  • PureVision® 2
  • PV2


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in corneal pain at the Follow-up Visit - Primary exposure [ Time Frame: Baseline, Follow-up Visit (up to 1 year following the Baseline 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 therapeutic contact lens was placed on eye as part of a treatment plan for a corneal condition. The Follow-up Visit is defined as the first visit where the 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. The primary exposure is defined as the first exposure to the study lens if, for example, there were multiple exposures to the study lens. The data collection period consists of any timeframe since and including 2009.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators will enroll charts following a pre-identified process.
Criteria

Inclusion Criteria:

  • Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
  • Baseline and Follow-up (up to 1 year from Baseline) charts available.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period.
  • Used systemic or ocular medication that would confound study results during the data collection period.
  • Other protocol-defined exclusion criteria may apply.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956535


Locations
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United States, Missouri
Koetting Associates
Saint Louis, Missouri, United States, 63144
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Clinical Trial Lead, CRD Vision Care Alcon Research, LLC
More Information
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT05956535    
Other Study ID Numbers: CLD265-N001
First Posted: July 21, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Alcon Research:
Bandage lens
Additional relevant MeSH terms:
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Corneal Dystrophies, Hereditary
Corneal Edema
Entropion
Corneal Diseases
 Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Eyelid Diseases