Contact Lens Adaptation in Neophytes (CLAN)

The Ohio State University

Status: Completed

Conditions: Contact Lens Comfort

Treatments: Device: senofilcon A

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02148263

K08EY023264 (U.S. NIH Grant/Contract)

2014H0074

Details and patient eligibility

About

Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice. This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day). The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively. The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear. Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys. Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home. All subjects will learn how to wear and take care of contact lenses. They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.

Enrollment: 25 patients

Sex: All

Ages: 8+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Has had a completed comprehensive eye exam within the past 6 months
• Able to wear spherical senofilcon A contact lenses
• Able to use Opti-Free PureMoist contact lens solution

Exclusion criteria

• Any prior contact lens use
• Topical eye drops within the last two hours of the study visit
• Known systemic health conditions known to alter tear film physiology
• History of severe ocular trauma
• Active ocular infection
• Active ocular inflammation
• Known hypersensitivity to diagnostic eye drops
• Pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Full-Time Senofilcon A Contact Lens Wear

Experimental group

Description:

This group will start wearing contact lenses 8 or more hours per day on the first day of wear

Treatment:

Device: senofilcon A

Graduated Senofilcon A Contact Lens Wear

Experimental group

Description:

This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours).

Treatment:

Device: senofilcon A