Ocular Comfort and OCT Observation of Post Lens Clearance and Ocular Tissue Compression

Ciba Vision

Status: Completed

Conditions: Ocular Comfort

Treatments: Device: Ultra-High Resolution Optical Coherence Tomographer (OCT); Device: Lotrafilcon A test contact lens; Device: Lotrafilcon A control contact lens

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01423773

P-367-C-800

Details and patient eligibility

About

The purpose of this study was to compare the fit and comfort of two types of contact lenses.

Full description

The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be of legal age of consent and sign Informed Consent document.
• Normal binocularity.
• Be able to wear soft contact lenses.
• Willing to comply with the wear and study visit schedule.
• Spherical contact lens prescription within 0.50 diopter of the available lens powers.
• Spectacle cylinder less than or equal to 1.50 diopter.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Eye injury or surgery within twelve weeks of enrollment.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Currently enrolled in any clinical trial.
• Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of accessory solutions as determined by the investigator.
• Other protocol-defined exclusion criteria may apply.

Trial design

20 participants in 2 patient groups

Lotrafilcon A test/lotrafilcon A control

Other group

Description:

Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.

Treatment:

Device: Lotrafilcon A control contact lens

Device: Lotrafilcon A test contact lens

Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)

Lotrafilcon A control/lotrafilcon A test

Other group

Description:

Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2.

Treatment:

Device: Lotrafilcon A control contact lens

Device: Lotrafilcon A test contact lens

Device: Ultra-High Resolution Optical Coherence Tomographer (OCT)