Contact Lens ComplicationNCT05290727
Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort
A study testing Aquoral Lipo (Esteve) and Hyabak (Thea) in people with Contact Lens Complication, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Contact Lens Complication
- What is being tested?
- Aquoral Lipo (Esteve) and Hyabak (Thea)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2022to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
In order to alleviate contact lens discomfort, 47% of professionals refit another contact lens of a different material or replacement frequency. 22% of professionals recommend the use of lubricants or moisturizers, and 15% change the maintenance system.
The use of artificial tears improves contact lens discomfort, mainly by instilling them prior to contact lens insertion, since it provides the moisturizing factor that maintenance solutions lack. During contact lens wear, they also improve comfort, visual quality, and reduce the production of contact lens deposits.
Aquoral Lipo is a preservative-free lubricant and antioxidant ophthalmic solution based on sodium salt of cross-linked hyaluronic acid, liposomes, and crocin. It provides good hydration and a long permanence time on the ocular surface.
Hypothesis:
"Aquoral Lipo" artificial tears are more effective than control artificial tears to improve symptomatology in contact lens wearers that suffer from discomfort symptoms.
Objective:
To compare the efficacy of Aquoral Lipo artificial tears with a product with 0.15% hyaluronic acid after 15 days of use in subjects with contact lens discomfort, and exposed to normal and adverse controlled conditions created in a controlled environment chamber.
Study plan:
Participants will perform a total of 5 visits (in 5 days): an inclusion visit (V0), two basal visits (V1 and V3), and two study visits (V2 and V4).
V0: Recruitment visit. Contact lens wearers will be recruited after checking inclusion and exclusion criteria. If eligible, participants will sign the informed consent and will be scheduled for V1 within the next 7 days.
V1: Baseline visit. Participants will come to the visit with a new pair of contact lenses and having worn them for at least 2 hours. Participants will enter the environmental chamber at the Controlled Environment Laboratory (CELab), where they will be exposed for 30 minutes to a normal controlled environment (23 degrees Celsius and 50 percentage relative humidity). Then, tests will be performed, and one of the study products will be dispensed to the subject randomly to be instilled 3-6 times a day until the next visit. Participants will come to the next visit within 15 days.
V2: Study visit (V2 NE - V2 AE). Participants will come to the visit having worn the contact lenses the same number of hours as in V1, and they will be exposed for 30 minutes to a normal controlled environment at CELab (V2 NE). Then, tests will be performed, and they will be exposed for 90 minutes to an adverse controlled environment (23 degrees Celsius and 10 percentage relative humidity) at CELab (V2 AE). Test will be repeated at 30, 60, and 90 minutes of the adverse environmental exposure. Subjects will not use artificial tears until the next visit, within the next 7 days.
V3: Baseline visit. The same procedures as in V1 will be followed, but the other study product will be dispensed to participants to be instilled 3-6 times a day until the next visit, within 15 days.
V4: Study visit (V4 NE - V4 AE). The same procedures as in V2 will be followed.
Clinical evaluation:
- Contact lens discomfort symptoms questionnaires
- Visual Acuity measurement
- Tear film lipid layer thickness measurement (interferometry)
- Blinking measurement
- Evaporimetry
- Non Invasive Break Up Time (NIBUT)
- Anterior pole biomicroscopy
- Tear Break Up Time with fluorescein (TBUT)
- Corneal staining with fluorescein
- Conjunctival staining with lissamine green
Data analysis:
Means and standard deviations will be calculated for the quantitative variables of the study. For ordinal variables, medians and interquartile ranges will be calculated. Qualitative variables will be summarized using percentages together with their confidence intervals.
For primary efficacy endpoint, CLDEQ-8 comparisons between V1 and V2 NE, and V3 and V4 NE will be performed by t-Student test for two paired samples.
The evolution of all variables over time will be analyzed through an ANOVA for repeated measures. Their evolution after the exposure to adverse environments will be analyzed through Student's t-test for paired samples (quantitative variables) and McNemar's test (ordinal variables).
- Conditions
- Contact Lens Complication
- Being tested
- Aquoral Lipo (Esteve), Hyabak (Thea)
- Keywords
- Contact lens, Discomfort, Artificial tears
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquoral Lipo (Esteve)Other
Also called 0.15% Hyaluronic Acid crosslinked with liposomes and crocin
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
Hyabak (Thea)Other
Also called 0.15% Hyaluronic Acid
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
| Study group | Role | What they receive |
|---|---|---|
| 0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea) | Other | 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 Receives: Other: Aquoral Lipo (Esteve); Other: Hyabak (Thea) |
| 0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve) | Other | 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 Receives: Other: Aquoral Lipo (Esteve); Other: Hyabak (Thea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After the use of the study product (15 days from treatment start)
Secondary outcomes (13)
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.
Measured: After the use of the study product (15 days from treatment start)
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.
Measured: After the use of the study product (15 days from treatment start)
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).
Measured: After the use of the study product (15 days from treatment start)
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.
Measured: After the use of the study product (15 days from treatment start)
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.
Measured: After the use of the study product (15 days from treatment start)
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.
Measured: After the use of the study product (15 days from treatment start)
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.
Measured: After the use of the study product (15 days from treatment start)
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.
Measured: After the use of the study product (15 days from treatment start)
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.
Measured: After the use of the study product (15 days from treatment start)
Hours of contact lens wear
Significant changes in the time of contact lens wear will be evaluated.
Measured: After the use of the study product (15 days from treatment start)
Comfortable hours of contact lens wear
Significant changes in the number of hours the patient is comfortable with contact lens wear.
Measured: After the use of the study product (15 days from treatment start)
Number of daily instillations of the products
Significant changes in the number of daily products instillations.
Measured: After the use of the study product (15 days from treatment start)
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".
Measured: After the use of the study product (15 days from treatment start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start1 Mar 2022
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Low intervention level, prospective, crossover, double masked, randomized, single center clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA
- Sponsor type
- University, hospital or other
- Collaborators
- Esteve
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290727
- Sponsor's protocol ID
- IOBA-2021-54
- Status last verified
- Oct 2024
- First submitted
- 22 Feb 2022
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of "Aquoral Lipo" Artificial Tears in Contact Lens Wearers With Discomfort Symptoms
- ClinicalTrials.gov ID
- NCT05290727
- Acronym / sponsor ID
- IOBA-2021-54
- Conditions
- Contact Lens Complication
- Keywords
- Contact lens, Discomfort, Artificial tears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBAUniversity, hospital or other
- Collaborators
- Esteve
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
In order to alleviate contact lens discomfort, 47% of professionals refit another contact lens of a different material or replacement frequency. 22% of professionals recommend the use of lubricants or moisturizers, and 15% change the maintenance system.
The use of artificial tears improves contact lens discomfort, mainly by instilling them prior to contact lens insertion, since it provides the moisturizing factor that maintenance solutions lack. During contact lens wear, they also improve comfort, visual quality, and reduce the production of contact lens deposits.
Aquoral Lipo is a preservative-free lubricant and antioxidant ophthalmic solution based on sodium salt of cross-linked hyaluronic acid, liposomes, and crocin. It provides good hydration and a long permanence time on the ocular surface.
Hypothesis:
"Aquoral Lipo" artificial tears are more effective than control artificial tears to improve symptomatology in contact lens wearers that suffer from discomfort symptoms.
Objective:
To compare the efficacy of Aquoral Lipo artificial tears with a product with 0.15% hyaluronic acid after 15 days of use in subjects with contact lens discomfort, and exposed to normal and adverse controlled conditions created in a controlled environment chamber.
Study plan:
Participants will perform a total of 5 visits (in 5 days): an inclusion visit (V0), two basal visits (V1 and V3), and two study visits (V2 and V4).
V0: Recruitment visit. Contact lens wearers will be recruited after checking inclusion and exclusion criteria. If eligible, participants will sign the informed consent and will be scheduled for V1 within the next 7 days.
V1: Baseline visit. Participants will come to the visit with a new pair of contact lenses and having worn them for at least 2 hours. Participants will enter the environmental chamber at the Controlled Environment Laboratory (CELab), where they will be exposed for 30 minutes to a normal controlled environment (23 degrees Celsius and 50 percentage relative humidity). Then, tests will be performed, and one of the study products will be dispensed to the subject randomly to be instilled 3-6 times a day until the next visit. Participants will come to the next visit within 15 days.
V2: Study visit (V2 NE - V2 AE). Participants will come to the visit having worn the contact lenses the same number of hours as in V1, and they will be exposed for 30 minutes to a normal controlled environment at CELab (V2 NE). Then, tests will be performed, and they will be exposed for 90 minutes to an adverse controlled environment (23 degrees Celsius and 10 percentage relative humidity) at CELab (V2 AE). Test will be repeated at 30, 60, and 90 minutes of the adverse environmental exposure. Subjects will not use artificial tears until the next visit, within the next 7 days.
V3: Baseline visit. The same procedures as in V1 will be followed, but the other study product will be dispensed to participants to be instilled 3-6 times a day until the next visit, within 15 days.
V4: Study visit (V4 NE - V4 AE). The same procedures as in V2 will be followed.
Clinical evaluation:
- Contact lens discomfort symptoms questionnaires
- Visual Acuity measurement
- Tear film lipid layer thickness measurement (interferometry)
- Blinking measurement
- Evaporimetry
- Non Invasive Break Up Time (NIBUT)
- Anterior pole biomicroscopy
- Tear Break Up Time with fluorescein (TBUT)
- Corneal staining with fluorescein
- Conjunctival staining with lissamine green
Data analysis:
Means and standard deviations will be calculated for the quantitative variables of the study. For ordinal variables, medians and interquartile ranges will be calculated. Qualitative variables will be summarized using percentages together with their confidence intervals.
For primary efficacy endpoint, CLDEQ-8 comparisons between V1 and V2 NE, and V3 and V4 NE will be performed by t-Student test for two paired samples.
The evolution of all variables over time will be analyzed through an ANOVA for repeated measures. Their evolution after the exposure to adverse environments will be analyzed through Student's t-test for paired samples (quantitative variables) and McNemar's test (ordinal variables).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Low intervention level, prospective, crossover, double masked, randomized, single center clinical trial
| Arm | Type | Receives |
|---|---|---|
| 0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea) | Other | Other: Aquoral Lipo (Esteve), Other: 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 |
| 0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve) | Other | Other: Aquoral Lipo (Esteve), Other: 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquoral Lipo (Esteve)Also: 0.15% Hyaluronic Acid crosslinked with liposomes and crocin15-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 | 0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea), 0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve) |
| Hyabak (Thea)Also: 0.15% Hyaluronic Acid15-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 | 0.15% Aquoral Lipo (Esteve) and 0.15% Hyabak (Thea), 0.15% Hyabak (Thea) and 0.15% Aquoral Lipo (Esteve) |
Primary outcome
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.
13 secondary outcomes
The CLDEQ-8
Time frame: After the use of the study product (15 days from treatment start)
The Contact Lens Discomfort Index
Time frame: After the use of the study product (15 days from treatment start)
Comfort and dryness Visual Assessment Scales
Time frame: After the use of the study product (15 days from treatment start)
Tear film stability
Time frame: After the use of the study product (15 days from treatment start)
Tear film evaporimetry
Time frame: After the use of the study product (15 days from treatment start)
Tear film interferometry
Time frame: After the use of the study product (15 days from treatment start)
Number of blinks
Time frame: After the use of the study product (15 days from treatment start)
Corneal staining
Time frame: After the use of the study product (15 days from treatment start)
Conjunctival staining
Time frame: After the use of the study product (15 days from treatment start)
Hours of contact lens wear
Time frame: After the use of the study product (15 days from treatment start)
Comfortable hours of contact lens wear
Time frame: After the use of the study product (15 days from treatment start)
Number of daily instillations of the products
Time frame: After the use of the study product (15 days from treatment start)
User satisfaction with the products
Time frame: After the use of the study product (15 days from treatment start)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquoral Lipo (Esteve) and Hyabak (Thea) in people with Contact Lens Complication, run by Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) (time frame: After the use of the study product (15 days from treatment start)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.