Evaluation of the Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Study Overview
Brief 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.
Detailed Description
Justification:
The number of contact lens wearers is increasing every year. It is estimated that there are approximately more than 140 million wearers worldwide. However, around 50% of them suffer from discomfort while wearing their lenses, and 12-51% of them stop wearing contact lenses. The most common experienced symptoms are dry eye, redness, foreign body sensation, poor vision, or sensitivity to light.
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.
Symptoms related to contact lens discomfort can be associated with visual acuity alterations, increased risk of ocular surface desiccation, or decreased contact lens wearing time. But the majority of subjects who develop discomfort with contact lenses do not have associated ocular pathology or damage.
Contact lens discomfort can be caused by factors associated with the contact lens itself, such as material, design, and maintenance systems; and factors associated with the environment surrounding the contact lens, such as those of the wearer or environmental conditions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study and control products will lack any identification label, except that concerning the assignment code. The product together with the instillation instructions will be delivered in a sealed envelope which will contain an identification label of the assignment code.
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea)
Dosage form: topical administration multidose ophthalmic eye drops Product usage order will be determined through randomization Duration: 15 days + 15 days Frequency: dosage between 3 and 6 drops per day
Intervention: Aquoral Lipo (Esteve) (Other)
0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea)
Dosage form: topical administration multidose ophthalmic eye drops Product usage order will be determined through randomization Duration: 15 days + 15 days Frequency: dosage between 3 and 6 drops per day
Intervention: Hyabak (Thea) (Other)
0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve)
Dosage form: topical administration multidose ophthalmic eye drops Product usage order will be determined through randomization Duration: 15 days + 15 days Frequency: dosage between 3 and 6 drops per day
Intervention: Aquoral Lipo (Esteve) (Other)
0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve)
Dosage form: topical administration multidose ophthalmic eye drops Product usage order will be determined through randomization Duration: 15 days + 15 days Frequency: dosage between 3 and 6 drops per day
Intervention: Hyabak (Thea) (Other)
Outcomes
Primary Outcomes
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)
Time Frame: After the use of the study product (15 days from treatment start)
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.
Secondary Outcomes
- The Contact Lens Discomfort Index(After the use of the study product (15 days from treatment start))
- Conjunctival staining(After the use of the study product (15 days from treatment start))
- User satisfaction with the products(After the use of the study product (15 days from treatment start))
- Number of blinks(After the use of the study product (15 days from treatment start))
- Comfortable hours of contact lens wear(After the use of the study product (15 days from treatment start))
- Tear film evaporimetry(After the use of the study product (15 days from treatment start))
- Tear film stability(After the use of the study product (15 days from treatment start))
- Tear film interferometry(After the use of the study product (15 days from treatment start))
- Hours of contact lens wear(After the use of the study product (15 days from treatment start))
- The CLDEQ-8(After the use of the study product (15 days from treatment start))
- Comfort and dryness Visual Assessment Scales(After the use of the study product (15 days from treatment start))
- Corneal staining(After the use of the study product (15 days from treatment start))
- Number of daily instillations of the products(After the use of the study product (15 days from treatment start))