Evaluation of Contact Lenses and Conjunctival Staining in Normal Patients

Alcon

Status: Completed

Conditions: Conjunctival Staining

Treatments: Device: Complete Easy Rub; Device: ReNu MultiPlus; Device: Clear Care; Device: Contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799422

M-08-02

Details and patient eligibility

About

The purpose of this study was to investigate contact lens fit, lens parameters, and conjunctival staining in a sample of subjects with various contact lens/solution combinations.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successfully wearing hydrogel and/or silicone hydrogel contact lenses;
• Read, sign, and date informed consent/HIPAA document;
• Vision correctable to 20/30 (Snellen) or better in each eye at distance with habitual spectacles;
• Willing and able to discontinue contact lens wear when requested during the study;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Evidence or history of ocular disease or pathology;
• One functional eye or a monofit lens;
• Use of concomitant topical ocular prescription or over-the-counter ocular medications;
• History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear;
• Other protocol-defined exclusion criteria may apply.

Trial design

26 participants in 3 patient groups

ReNu MultiPlus

Active Comparator group

Description:

ReNu MultiPlus used as specified in the protocol for contact lens care. In this crossover study, ReNu MultiPlus was dispensed in randomized order with Complete Easy Rub and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Treatment:

Device: Contact lenses

Device: ReNu MultiPlus

Complete Easy Rub

Active Comparator group

Description:

Complete Easy Rub used as specified in the protocol for contact lens care. In this crossover study, Complete Easy Rub was dispensed in randomized order with ReNu MultiPlus and Clear Care. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Treatment:

Device: Contact lenses

Device: Complete Easy Rub

Clear Care

Active Comparator group

Description:

Clear Care used as specified in the protocol for contact lens care. In this crossover study, Clear Care was dispensed in randomized order with Complete Easy Rub and ReNu MultiPlus. Each product was used for one week with a fresh pair of Acuvue Oasys contact lenses. A 36-hour washout preceded each usage period.

Treatment:

Device: Contact lenses

Device: Clear Care