Corneal DiseasePhase 4NCT05045053
Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking
A Phase 4 study testing Xiidra 5% Ophthalmic Solution in people with Corneal Disease, run by Benha University at 1 site in United Arab Emirates.
Trial summary
dry eye disease after corneal collagen cross linking affect ocular function leading to reduced vision, photophobia, glare, halos, and foreign body sensation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Disease
- What is being tested?
- Xiidra 5% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Feb 2021to Jan 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- corneal collagen cross linking
Who cannot join
- systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
INMC
Abu Dhabi, 46266
TAREK R ELHAMAKY, MD
About this study
Official title: Efficacy of Xiidra in the Management Dry Eye Disease After Corneal Collagen Cross Linking
dry eye disease after corneal collagen cross linking affect ocular function leading to reduced vision, photophobia, glare, halos, and foreign body sensation.
Read the detailed description
first group of patients were treated with 0.5 % xiidra twice daily and artificial tears for 6 months.Second group treated with artificial tears for 6 months. the treatment starts after corneal collagen cross linking in both groups ,Baseline and post-treatment full ophthalmic examination was done.
- Conditions
- Corneal Disease
- Being tested
- Xiidra 5% Ophthalmic Solution
- Keywords
- dry eye, cross linking, xiidra
- Medical subject headings
- Corneal Diseases, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiidra 5% Ophthalmic SolutionDrug
Also called lifitegrast
lifitegrast 0.5% ia applied twice daily after corneal collagen cross linking
| Study group | Role | What they receive |
|---|---|---|
| xiidra group | Experimental | patients are treated with 0.5 % xiidra twice daily and artificial tears for 6 months after corneal collagen cross linking Receives: Drug: Xiidra 5% Ophthalmic Solution |
| control group | No intervention | patient are treated with artificial tears for 6 months after corneal collagen cross linking in both groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Break up Time
fluorescein sodium stripes will be used for measurement of Break up Time in seconds at baseline and during the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Feb 2021
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
- Investigators
- Tarek Elhamaky, Principal investigator, Benha university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045053
- Sponsor's protocol ID
- Hamaky17
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Xiidra in the Management Dry Eye Disease After Corneal Collagen Cross Linking
- ClinicalTrials.gov ID
- NCT05045053
- Acronym / sponsor ID
- Hamaky17
- Conditions
- Corneal Disease
- Keywords
- dry eye, cross linking, xiidra
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 16 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.
dry eye disease after corneal collagen cross linking affect ocular function leading to reduced vision, photophobia, glare, halos, and foreign body sensation.
Detailed description
first group of patients were treated with 0.5 % xiidra twice daily and artificial tears for 6 months.Second group treated with artificial tears for 6 months. the treatment starts after corneal collagen cross linking in both groups ,Baseline and post-treatment full ophthalmic examination was done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| xiidra group | Experimental | Drug: Xiidra 5% Ophthalmic Solutionpatients are treated with 0.5 % xiidra twice daily and artificial tears for 6 months after corneal collagen cross linking |
| control group | No intervention | –patient are treated with artificial tears for 6 months after corneal collagen cross linking in both groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- corneal collagen cross linking
Key exclusion criteria (1 listed)
- systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers
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 |
|---|---|---|
| Xiidra 5% Ophthalmic SolutionAlso: lifitegrastlifitegrast 0.5% ia applied twice daily after corneal collagen cross linking | Drug | xiidra group |
Primary outcome
Change in Break up Time
Time frame: 6 months
fluorescein sodium stripes will be used for measurement of Break up Time in seconds at baseline and during the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
Related trials for Corneal Disease
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, Fuchs Dystrophy
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
Keratitis Bacterial, Keratitis Fungal
Not yet recruiting
A Single-Center Clinical Study Evaluating the Efficacy and Safety of Allogeneic Natural Killer (NK) Cell Transplantation for Mooren's Ulcer
Cornea Disease
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
Tarek Elhamaky principal investigator
Benha university faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiidra 5% Ophthalmic Solution in people with Corneal Disease, run by Benha University at 1 site in United Arab Emirates.
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 1 inclusion and 1 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 16 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 United Arab Emirates. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Tarek R Elhamaky, M.D. (+971 503207889, dr_thamakyy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Break up Time (time frame: 6 months). 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 16 Sep 2021.