Visual Performance Investigation of Two Toric Soft Contact Lenses (CARDINAL)

Alcon

Status: Completed

Conditions: Myopia; Refractive Error; Astigmatism; Hyperopia

Treatments: Device: Comfilcon A toric contact lens; Device: Lotrafilcon B toric contact lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT01858701

P/438/13/L

A01335

Details and patient eligibility

About

The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Sign informed consent;
• Wears toric soft contact lenses;
• Can be successfully fit with study lenses within the power ranges available;
• Has cylinder of ≥ -0.75 diopter in both eyes;
• Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;
• Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Any ocular condition that would contraindicate contact lens wear;
• Use of medications for which contact lens wear could be contraindicated;
• Monocular (only 1 eye with functional vision) or fit with 1 lens;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Requires presbyopic correction;
• Use of rewetting/lubricating eye-drops more than twice a day;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

49 participants in 2 patient groups

AO for Astig / Biofinity Toric

Other group

Description:

Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.

Treatment:

Device: Lotrafilcon B toric contact lens

Device: Comfilcon A toric contact lens

Biofinity Toric / AO for Astig

Other group

Description:

Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2, as randomized. Each product will be worn bilaterally on a daily wear basis for 30 days, removed nightly. A minimum 1-day washout of no contact lens wear will precede each wear period.

Treatment:

Device: Lotrafilcon B toric contact lens

Device: Comfilcon A toric contact lens