Ocular Surface SymptomPhase 1NCT06624384
Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024
A Phase 1 study testing Group 1 drug and Group 3: Drug and palcebo in people with Ocular Surface Symptom and Ocular Surface Disease, run by Mohsen Pourazizi at 1 site in Iran.
Trial summary
The goal of this clinical trial is to compare the administration of 2 drugs, cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before PRK, in reducing the ocular surface symptom of patients after PRK. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Symptom, Ocular Surface Disease, Eye Pain
- What is being tested?
- Group 1 drug and Group 3: Drug and palcebo
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIran
- Study dates
- 30 Oct 2024to 30 Dec 2024
- Phase
- Phase 1
- 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
- Age above 18 years Myopia and myopic astigmatism The stability of the patients refraction over the past year Not using contact lenses at least 3 weeks before the operation Absence of history of KCN and any type of corneal ectasia in the patient himself or his first degree family No history of previous eye surgery and eye trauma Absence of active eye diseases, corneal dystrophy, retinal diseases, glaucoma, dry eyes of any degree.
- Absence of systemic diseases that can potentially disrupt wound healing, including diabetes, vascular collagen diseases, and pregnancy.
- Not taking inhaled or systemic steroids actively or within 3 months before the procedure Absence of anisometropia Not using any systemic and topical analgesia during the last week
Who cannot join
- The patients lack of consent to continue the study Failure to visit the patient for follow-up The occurrence of any complications during the patients surgery
Trial locations and contacts
1 site in 1 country.
Iran1 site
Isfahan University of Medical Sciences, Feiz Hospital, Isfahan
Isfahan, Isfahan
Mohsen Pourazizi, Clinical Professor, 0098 + 09126532785, m.pourazizi@yahoo.com
About this study
Official title: Efficacy and Safety of Topical Cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) on the Ocular Surface Symptom After Photorefractive Keratectomy (PRK) in Feiz Hospital, Isfahan, 2024
The goal of this clinical trial is to compare the administration of 2 drugs, cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before PRK, in reducing the ocular surface symptom of patients after PRK. The main questions it aims to answer are:
1- Does the use of cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before photorefractive keratectomy surgery (PRK) reduce ocular surface symptom such as eye pain, redness, and inflammation in conjunctivitis in patients? Researchers will compare cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) to a placebo (Artelac artificial tears) to see if cyclosporine 0.05% and Lifitgrast works to reduce ocular surface symptom.
Read more
Participants will:
Take drug cyclosporine 0.05% and Lifitgrast or a Artelac 30 minutes before surgery Visit the clinic 6 hours, one day, three days and one week after photorefractive keratectomy (PRK) for checkups and tests
Read the detailed description
Considering the increasing importance of reducing eye symptoms of patients after PRK surgery and the impact of this issue on the quality of life of patients, as well as the lack of sufficient studies on the effect of different drugs in this field and comparing their effects, which ultimately lead to the decision and clinical application of this Regarding the category of drugs, the present study aims to compare the administration of 2 drugs, cyclosporine 0.05% and Lifitgrast before PRK, in reducing the eye symptoms of patients after PRK.
In this study, 15 minutes before the start of photorefractive keratectomy surgery, we divide the patients into 3 random groups and according to the following plan, we put the drops into the eyes of the patients.
The first group: one eye drop cyclosporine 0.05% - opposite eye drop Lifitgrast The second group: one eye with 0.05% cyclosporine drops - the opposite eye with Artlac artificial tear drops The third group: one eye with Liffitgrast drops - the opposite eye with Artlac artificial tear drops Patients will be evaluated and examined according to variables 6 hours, one day, three days and one week after the operation. To check the symptoms of patients from standard questionnaires including Ocular surface disease index (OSDI), visual analogue scale (VAS) Wong-Baker FACES, Efron is used.
- Being tested
- Group 1 drug, Group 2: Drug and placebo, Group 3: Drug and palcebo
- Keywords
- PRK- ocular surface symptom - cyclosporine 0.05% - Lifitgrast (Xiidra)
- Medical subject headings
- Eye Pain, Endophthalmitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 drugDrug
Also called drug
Group 1: In this group, the aim is to compare 2 drugs, cyclosporine 0.05% and Lifitgrast . In one eye, cyclosporine 0.05% eye drops are randomly poured and in the opposite eye, Lifitgrast eye drops are poured.
Group 2: Drug and placeboDrug
Group 2: In this group, the aim is to compare 2 drugs, cyclosporine 0.05% and Artelac artificial tear as a placebo. In one eye, cyclosporine 0.05% eye drops are randomly poured, and in the opposite eye, Artelac artificial tear are poured.
Group 3: Drug and palceboDrug
Group 3: In this group, the aim is to compare 2 drugs, Lifitgrast and Artelac artificial tear as a placebo. In one eye, Lifitgrast eye drops are randomly poured, and in the opposite eye, Artelac artificial tear are poured.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Drug group (topical cyclosporine 0.05% and Lifitgrast) | Active comparator | Group 1: In this group, cyclosporine 0.05% drops are poured into one eye and Lifitgrast drops are poured into the opposite eye. Receives: Drug: Group 1 drug |
| Group 2: drug and placebo (cyclosporine 0.05%-Artlac) | Active comparator | Group 2: In this group, cyclosporine 0.05% drops are poured into one eye and artelac drops are poured into the opposite eye. Receives: Drug: Group 2: Drug and placebo |
| Group 3: drug and placebo (Lifitgrast-Artlac) | Active comparator | Group 3: In this group, Lifitgrast drops are poured into one eye and artelac drops are poured into the opposite eye. Receives: Drug: Group 3: Drug and palcebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
average eye inflammatory symptoms in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy.
The average inflammatory symptoms of the ocular surface symptoms including pain, burning and itching, redness and conjunctivitis in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy(PRK) using a standard questionnaire including Ocular Surface Disease Index (OSDI), Visual Analogue Scale (VAS), Wang Baker FACES and Efron is measured.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface SymptomStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohsen Pourazizi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohsen Pourazizi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624384
- Sponsor's protocol ID
- IR.MUI.MED.REC.1403.129
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Topical Cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) on the Ocular Surface Symptom After Photorefractive Keratectomy (PRK) in Feiz Hospital, Isfahan, 2024
- ClinicalTrials.gov ID
- NCT06624384
- Acronym / sponsor ID
- IR.MUI.MED.REC.1403.129
- Keywords
- PRK- ocular surface symptom - cyclosporine 0.05% - Lifitgrast (Xiidra)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mohsen PouraziziUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 Oct 2024 (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.
The goal of this clinical trial is to compare the administration of 2 drugs, cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before PRK, in reducing the ocular surface symptom of patients after PRK. The main questions it aims to answer are:
1- Does the use of cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before photorefractive keratectomy surgery (PRK) reduce ocular surface symptom such as eye pain, redness, and inflammation in conjunctivitis in patients? Researchers will compare cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) to a placebo (Artelac artificial tears) to see if cyclosporine 0.05% and Lifitgrast works to reduce ocular surface symptom.
Participants will:
Take drug cyclosporine 0.05% and Lifitgrast or a Artelac 30 minutes before surgery Visit the clinic 6 hours, one day, three days and one week after photorefractive keratectomy (PRK) for checkups and tests
Detailed description
Considering the increasing importance of reducing eye symptoms of patients after PRK surgery and the impact of this issue on the quality of life of patients, as well as the lack of sufficient studies on the effect of different drugs in this field and comparing their effects, which ultimately lead to the decision and clinical application of this Regarding the category of drugs, the present study aims to compare the administration of 2 drugs, cyclosporine 0.05% and Lifitgrast before PRK, in reducing the eye symptoms of patients after PRK.
In this study, 15 minutes before the start of photorefractive keratectomy surgery, we divide the patients into 3 random groups and according to the following plan, we put the drops into the eyes of the patients.
The first group: one eye drop cyclosporine 0.05% - opposite eye drop Lifitgrast The second group: one eye with 0.05% cyclosporine drops - the opposite eye with Artlac artificial tear drops The third group: one eye with Liffitgrast drops - the opposite eye with Artlac artificial tear drops Patients will be evaluated and examined according to variables 6 hours, one day, three days and one week after the operation. To check the symptoms of patients from standard questionnaires including Ocular surface disease index (OSDI), visual analogue scale (VAS) Wong-Baker FACES, Efron is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Drug group (topical cyclosporine 0.05% and Lifitgrast) | Active comparator | Drug: Group 1 drugGroup 1: In this group, cyclosporine 0.05% drops are poured into one eye and Lifitgrast drops are poured into the opposite eye. |
| Group 2: drug and placebo (cyclosporine 0.05%-Artlac) | Active comparator | Drug: Group 2: Drug and placeboGroup 2: In this group, cyclosporine 0.05% drops are poured into one eye and artelac drops are poured into the opposite eye. |
| Group 3: drug and placebo (Lifitgrast-Artlac) | Active comparator | Drug: Group 3: Drug and palceboGroup 3: In this group, Lifitgrast drops are poured into one eye and artelac drops are poured into the opposite eye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18 years Myopia and myopic astigmatism The stability of the patients refraction over the past year Not using contact lenses at least 3 weeks before the operation Absence of history of KCN and any type of corneal ectasia in the patient himself or his first degree family No history of previous eye surgery and eye trauma Absence of active eye diseases, corneal dystrophy, retinal diseases, glaucoma, dry eyes of any degree.
- Absence of systemic diseases that can potentially disrupt wound healing, including diabetes, vascular collagen diseases, and pregnancy.
- Not taking inhaled or systemic steroids actively or within 3 months before the procedure Absence of anisometropia Not using any systemic and topical analgesia during the last week
Key exclusion criteria (1 listed)
- The patients lack of consent to continue the study Failure to visit the patient for follow-up The occurrence of any complications during the patients surgery
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 |
|---|---|---|
| Group 1 drugAlso: drugGroup 1: In this group, the aim is to compare 2 drugs, cyclosporine 0.05% and Lifitgrast . In one eye, cyclosporine 0.05% eye drops are randomly poured and in the opposite eye, Lifitgrast eye drops are poured. | Drug | Group 1: Drug group (topical cyclosporine 0.05% and Lifitgrast) |
| Group 2: Drug and placeboGroup 2: In this group, the aim is to compare 2 drugs, cyclosporine 0.05% and Artelac artificial tear as a placebo. In one eye, cyclosporine 0.05% eye drops are randomly poured, and in the opposite eye, Artelac artificial tear are poured. | Drug | Group 2: drug and placebo (cyclosporine 0.05%-Artlac) |
| Group 3: Drug and palceboGroup 3: In this group, the aim is to compare 2 drugs, Lifitgrast and Artelac artificial tear as a placebo. In one eye, Lifitgrast eye drops are randomly poured, and in the opposite eye, Artelac artificial tear are poured. | Drug | Group 3: drug and placebo (Lifitgrast-Artlac) |
Primary outcome
average eye inflammatory symptoms in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy.
Time frame: 1 week
The average inflammatory symptoms of the ocular surface symptoms including pain, burning and itching, redness and conjunctivitis in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy(PRK) using a standard questionnaire including Ocular Surface Disease Index (OSDI), Visual Analogue Scale (VAS), Wang Baker FACES and Efron is measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Group 1 drug and Group 3: Drug and palcebo in people with Ocular Surface Symptom and Ocular Surface Disease, run by Mohsen Pourazizi at 1 site in Iran.
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 3 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 3 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 Iran. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Mohsen Pourazizi, Clinical Professor (0098 + 09126532785, m.pourazizi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average eye inflammatory symptoms in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy. (time frame: 1 week). 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 3 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.