On-Eye Evaluation of Contact Lens Axis Location

Alcon Research50 enrolled

Overview

The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark \[TEST1 (T1), TEST3 (T3), TEST5 (T5)\], worn on the right eye, and 1 lens without embossed mark \[TEST2 (T2), TEST4 (T4), and TEST6 (T6)\] worn on the left eye.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Myopia Astigmatism Refractive Error

Interventions

Delefilcon A toric contact lens T1DEVICE

Iteration 2-87-1 with embossed mark

Delefilcon A toric contact lens T2DEVICE

Iteration 2-87-1 without embossed mark

Delefilcon A toric contact lens T3DEVICE

Iteration 2-87-2 with embossed mark

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Sign written Informed Consent. * Best corrected distance visual acuity greater than or equal to 20/25 in each eye. * Other protocol-defined inclusion criteria may apply. Exclusion Criteria: * History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study. * Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear. * History of herpetic keratitis. * Slit-lamp findings at baseline as specified in the protocol. * Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear. * Clinically significant dry eye not responding to treatment. * History of refractive surgery. * Other protocol-defined exclusion criteria may apply.

Outcomes

Primary Outcomes

Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear

Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).

Time frame: Day 1

Secondary Outcomes

Lens Awareness

Lens awareness was assessed by the participant on a 5-point scale (0=none and 4=severe) within the first 5 minutes of wear for each eye separately.

Time frame: Day 1

Handling on Removal

Handling on removal (after 30 minutes of wear) was assessed by the participant on a scale from 1 to 10 (1=poor and 10=excellent). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).

Time frame: Day 1

Data from ClinicalTrials.gov

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