AOSEPT (CLEAR CARE) PLUS Study

Alcon

Status: Withdrawn

Conditions: Contact Lens Care

Treatments: Device: AOSEPT Plus and AOCup lens case; Device: AOSEPT Plus with HydraGlyde and AOCup lens case; Device: Habitual contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT06588400

LCT783-P001

Details and patient eligibility

About

The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.

Full description

Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subject and parent/legally authorized representative able to understand and sign an Institution Review Board approved informed consent/assent form.
• Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
• Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any ocular disease or condition that would contraindicate contact lens wear.
• Use of systemic or ocular medication that would contraindicate contact lens wear.
• Any known sensitivity to any ingredients in the study products.
• Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
• Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
• Other protocol-specified exclusion criteria may apply.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

AOSEPT Plus (CC)

Experimental group

Description:

AOSEPT Plus and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.

Treatment:

Device: Habitual contact lenses

Device: AOSEPT Plus and AOCup lens case

AOSEPT Plus with HydraGlyde (CCP)

Experimental group

Description:

AOSEPT Plus with HydraGlyde and AOCup lens case used as instructed with habitual contact lenses for 90 days. It is expected that the habitual contact lenses will be worn for at least 8 hours per day for at least 5 days per week during study participation.

Treatment:

Device: Habitual contact lenses

Device: AOSEPT Plus with HydraGlyde and AOCup lens case