Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort

Summary

There are more than 140 million contact lens wearers in the world. However, contact lens use can cause discomfort symptoms in up to 50% of wearers. And these symptoms can lead to contact lens abandonment in 12-51% of symptomatic wearers.

Contact lens discomfort is defined by the Tear Film \& Ocular Surface Society (TFOS) as a condition characterized by episodic or persistent adverse ocular sensations related to contact lens wear, either with or without visual disturbance, resulting from reduced compatibility between the contact lens and the ocular environment, which can lead to decreased wearing time and discontinuation of contact lens wear.

The most common cause of contact lens discontinuation is discomfort and dryness symptoms. This symptomatology is associated with visual acuity alterations, increased risk of ocular surface desiccation, or decreased contact lens wearing time. But the different signs found in contact lens wearers who present discomfort with contact lenses do not always correlate with the symptoms they report. In addition, different factors negatively impact contact lens discomfort such as low relative humidity environments.

In order to alleviate contact lens discomfort, the first option chosen by professionals is fitting another contact lens with different replacement frequency or material. The second option is recommending the use of lubricants or moisturizers, and the third one is changing the maintenance system.

The use of artificial tears is an effective way to improve contact lens discomfort, mainly by instilling them prior to contact lens insertion, since it provides the moisturizing factor that maintenance solutions lack. In addition, it improves comfort, visual quality, and reduces the production of deposits on the contact lens.

The hypothesis of this clinical trial is that "Aquoral Lipo" artificial tears are more effective than control artificial tears to improve symptomatology in contact lens wearers with discomfort symptoms.

The study will compare the effect of both "Aquoral Lipo" and control artificial tears under controlled normal and adverse environmental conditions.

Conditions

• Contact Lens Complication

Interventions

OTHER

Aquoral Lipo (Esteve)

15-day randomized treatment period of each of the clinical trial products (experimental and control) with a 1-week washout period prior to use of the study products

OTHER

Hyabak (Thea)

15-day randomized treatment period of each of the clinical trial products (experimental and control) with a 1-week washout period prior to use of the study products

Sponsors & Collaborators

• Esteve

  collaborator OTHER

• Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-01

Primary Completion

2024-07-12

Completion

2024-07-12

Countries

• Spain

Study Locations