Comparison of Two Contact Lens Designs

Southern College of Optometry

Status: Completed

Conditions: Accommodation; Computer Vision Syndrome

Treatments: Device: Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens

Study type: Interventional

Funder types: Other

Identifiers

NCT07488208

SCO IRB00006733

Details and patient eligibility

About

The proposed study will address this gap by comparing the efficacy of two novel stenfilcon A contact lens designs in alleviating accommodative burden associated with digital device usage.

The primary outcomes are measured with the following:

• Computer vision syndrome questionnaire
• Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm.
• Binocular range of clear vision
• Subjective assessment of accommodation
• Objective assessment of accommodation Subjects will be randomly assigned to wear one contact lens design for 5 days. Then crossed over tot he opposing design after a three day washout period, and again asked to wear the lens for 5 days.

Full description

Digital device use is associated with symptoms known as Computer Vision Syndrome (CVS), which may include eye strain, dryness, blurred vision, and headaches. Contact lens wearers may experience increased symptoms during prolonged near-focus activities. New contact lens designs have been developed to help reduce accommodative stress during digital device use; however, clinical evidence comparing their performance remains limited.

This randomized, double-masked, crossover study will compare two daily disposable stenfilcon A contact lenses. Each participant will wear both lens designs for five days each, separated by a three-day washout. Primary outcomes include subjective symptoms, visual acuity, range of clear vision, subjective accommodative performance, and objective accommodative response. The study is designed to provide evidence regarding the relative performance of the two lens designs in reducing visual discomfort and accommodative burden during digital device use.

Enrollment: 30 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Score of >6 on CVS-Q
• Male or female
• Age >18 years to 35 years of age
• Experienced, well-adapted contact lens wearers
• Spherical equivalent refractive error between ±6.00DS with astigmatism < -0.75D
• Normal stereopsis and binocular status

Exclusion criteria

• Monovision
• History of refractive surgery
• Binocular vision abnormalities
• Current ocular or systemic disease that may affect the eye
• Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

30 participants in 2 patient groups

Initial assignment to MyDay

Other group

Description:

Subject assigned to MyDay contact lens then crossed over to MyDay Energys

Treatment:

Device: Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens

Initial assignment to MyDay Energys

Other group

Description:

Subject assigned to MyDay Energys contact lens then crossed over to MyDay contact lens.

Treatment:

Device: Stenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens