Contact Lens Complication Clinical Trial
Official title:
Evaluation of the Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort Symptoms
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.
Status | Recruiting |
Enrollment | 41 |
Est. completion date | December 2023 |
Est. primary completion date | November 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - Age > 18 years - Signature of informed consent form - Regular hydrophilic contact lens wearers: at least 4 times a week and at least 4 hours a day - Contact lens discomfort measured as a Contact Lens Dry Eye Questionnaire-8 score higher than 11 points Exclusion Criteria: - Known sensitivity or intolerance to some of the products used in the study - Habitual non-compliance of the contact lens replacement frequency - Any systemic disease or treatment that alters the eye - Any ocular surgery, infection, inflammation, or active eye disease, in the last year - Autoimmune dry eye - Participation in a clinical trial within 30 days prior to entry into this study - Pregnancy or breastfeeding |
Country | Name | City | State |
---|---|---|---|
Spain | IOBA - University of Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA | Esteve |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Visual acuity | Changes of at least one line of visual acuity not improvable with correction or instillation of artificial tears.
Visual acuity will be measured monocularly using the Age-Related Eye Disease Study (AREDS) Study Group modification of the Diabetic Retinopathy Early Treatment Study Group (ETDRS) method, at a distance of 4 meters. |
45 days after screening visit | |
Other | Presence of ocular or periorbital adverse events | The frequency of adverse events between the two study products (experimental and control) and the percentage of events that involves the withdrawal of patients from the study will be determined. | 45 days after screening visit | |
Primary | The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) | Significant changes of at least 3 points in the questionnaire between the two products (study and control).
This questionnaire quantifies the symptoms of ocular discomfort during the use of contact lenses. Values up to 37 points are obtained, with higher values representing greater symptomatology. |
After the use of the study product (15 days from treatment start) | |
Secondary | The CLDEQ-8 | Significant changes after exposure to normal and adverse environments. This questionnaire quantifies the symptoms of ocular discomfort during the use of contact lenses. Values up to 37 points are obtained, with higher values representing greater symptomatology. | After the use of the study product (15 days from treatment start) | |
Secondary | The Contact Lens Discomfort Index | Significant changes after exposure to normal and adverse environments. This questionnaire allows establishing the presence of contact lens discomfort according to its symptoms. Values up to 18 points are obtained, with higher values representing greater symptomatology. | After the use of the study product (15 days from treatment start) | |
Secondary | Comfort and dryness Visual Assessment Scales | Significant changes after exposure to normal and adverse environments. Visual Assessment Scales evaluate ocular comfort and dryness during contact lens wear by using a horizontal straight line of 100 mm that allows assessment on a scale of 0 to 100 points (higher values indicating greater symptoms). | After the use of the study product (15 days from treatment start) | |
Secondary | Tear film stability | Significant changes after exposure to normal and adverse environments. Tear break up time will be evaluated by instilling fluorescein sodium in the inferior conjunctival fornix. Tear film pattern will be observed through a slit lamp with the cobalt blue filter, and through a #12 Wratten yellow filter. The time between the last blink and the moment when the first black spot appears will be noted in seconds. | After the use of the study product (15 days from treatment start) | |
Secondary | Tear film evaporimetry | Significant changes after exposure to normal and adverse environments. Tear evaporation rate (g/m²h) will be evaluated using a closed chamber evaporimeter without ventilation, the Eye Vapometer. The subject will be asked to blink normally and remain in the primary gaze position while measurements are taken with the eyes open and closed. | After the use of the study product (15 days from treatment start) | |
Secondary | Tear film interferometry | Significant changes after exposure to normal and adverse environments. The value of the lipid layer thickness obtained through the interferometric pattern of the tear film will be observed and measured in a scale of 0-100 nm. | After the use of the study product (15 days from treatment start) | |
Secondary | Number of blinks | Significant changes after exposure to normal and adverse environments. Number of times the subject blinks during a period of 20 seconds will be counted. | After the use of the study product (15 days from treatment start) | |
Secondary | Corneal staining | Significant changes in corneal staining after adverse environments. To assess corneal staining, fluorescein sodium will be instilled in the inferior conjunctival fornix. The surface of the cornea will be examined under a slit lamp through the cobalt blue and a #12 Wratten yellow filters. The intensity of the corneal fluorescein staining will be graded on a scale of 0 to 4 degrees according to the Oxford scale. | After the use of the study product (15 days from treatment start) | |
Secondary | Conjunctival staining | Significant changes in conjunctival staining after adverse environments. Lissamine green strips will be used and moistened with physiological serum. They will be instilled by impregnating the superior bulbar conjunctiva. Nasal and temporal conjunctival areas will be evaluated and assessed on a scale of 0 to 4 degrees according to the Oxford scale. | After the use of the study product (15 days from treatment start) | |
Secondary | Hours of contact lens wear | Significant changes in the time of contact lens wear will be evaluated. | After the use of the study product (15 days from treatment start) | |
Secondary | Comfortable hours of contact lens wear | Significant changes in the number of hours the patient is comfortable with contact lens wear. | After the use of the study product (15 days from treatment start) | |
Secondary | Number of daily instillations of the products | Significant changes in the number of daily products instillations. | After the use of the study product (15 days from treatment start) | |
Secondary | User satisfaction with the products | Significant changes in the products satisfaction. Satisfaction with the products will be assessed on a horizontal line of 100 mm and graded between 0-10 points. The left end indicates the subject is extremely dissatisfied and the right end indicates the subject is extremely satisfied. The evaluation will be carried out by measuring with a millimeter ruler the distance from the left end, giving it a value of "zero", to the right with a value of "one hundred". | After the use of the study product (15 days from treatment start) |
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