Contact Lens ComplicationEYEBRIDNCT05036954
Observational Study on the Efficacy and Tolerance of EYEBRID Lenses
An observational study of Contact Lens Complication, run by University Hospital, Caen at 1 site in France.
Trial summary
Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Contact Lens Complication
- What is being tested?
- EyeBrid Excel hybrid lenses
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 30 Sep 2021to 30 Jul 2022
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Contact lens wearers, cohort of 60 patients
Who may be able to join
- o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or
- Wear rigid lenses and have objective intolerances (damage to surfaces related to rigid lenses) or
- Are new wearers of lenses and presenting a strong ametropia (Strong myopia from -5.00 to -30.00d, strong hyperopia from + 4.50d to + 30.00d, strong astigmatism from 2.50d to 12.00d), with or without presbyopia (Addition of 0.75d to 3.50d)
- Any patient diagnosed with Keratoconus stages 1 to 3.
- Be affiliated to the social security system
Who cannot join
- Patient with contraindications to wearing contact lenses
- Pregnant or breastfeeding woman
- Any minor or over 80 years old
- Any infection, inflammation or abnormality of the anterior segments
- Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
- Use of systemic or ocular treatment products for which the wearing of contact lenses would be discouraged;
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- History of any herpetic keratitis;
- History of any refractive surgery or any irregular cornea (except in cases where the contact lenses examined may be worn by a subject with an irregular cornea, suffering from keratoconus or having undergone refractive surgery);
- Slit lamp observations of greater than grade 1 gravity;
- Vascularization of the cornea with a penetration greater than 1 mm;
- Case of pathological dry eye;
- When a subject has participated in a clinical trial on contact lenses or contact lens care products within the past 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.
This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.
- Conditions
- Contact Lens Complication
- Being tested
- EyeBrid Excel hybrid lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeBrid Excel hybrid lensesDevice
new lenses
| Study group | Role | What they receive |
|---|---|---|
| no arm | Not described Receives: Device: EyeBrid Excel hybrid lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
tolerance assesment
scale of discomfort when using contact lenses
Measured: 3 month
Secondary outcomes (2)
Improvement of visual acuity
measurement of visual acuity by the ETDRS charts
Measured: 3 month
Assessment and quantification of complications
note the number of abscesses
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start30 Sep 2021 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Jul 2022 (estimated)
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.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036954
- Sponsor's protocol ID
- 21-0045
- Acronym
- EYEBRID
- Status last verified
- Jul 2021
- First submitted
- 12 Jun 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Efficacy and Tolerance of EYEBRID Lenses
- ClinicalTrials.gov ID
- NCT05036954
- Acronym / sponsor ID
- EYEBRID / 21-0045
- Conditions
- Contact Lens Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 8 Sep 2021 (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.
Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.
This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no arm | – | Device: EyeBrid Excel hybrid lenses |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Contact lens wearers, cohort of 60 patients
Key inclusion criteria (5 listed)
- o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or
- Any patient diagnosed with Keratoconus stages 1 to 3.
- Be affiliated to the social security system
Key exclusion criteria (12 listed)
- Patient with contraindications to wearing contact lenses
- Pregnant or breastfeeding woman
- Any minor or over 80 years old
- Any infection, inflammation or abnormality of the anterior segments
- Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
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 |
|---|---|---|
| EyeBrid Excel hybrid lensesnew lenses | Device | no arm |
Primary outcome
tolerance assesment
Time frame: 3 month
scale of discomfort when using contact lenses
2 secondary outcomes
Improvement of visual acuity
Time frame: 3 month
Assessment and quantification of complications
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contact Lens Complication, run by University Hospital, Caen at 1 site in France.
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 5 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 8 Sep 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Claude Quintyn, MD, PhD (00 33 2 31 06 46 30, quintyn-jc@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tolerance assesment (time frame: 3 month). 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 Sep 2021.