Must be PRK CandidatePhase 4NCT02974387
Safety and Efficacy of Lotemax Versus FML in Subjects Undergoing PRK for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
A Phase 4 study testing Fluorometholone(FML) and Loteprednol (Lotemax) in people with Must be PRK Candidate, run by Dr Salouti Eye Research Center.
Trial summary
STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy (PRK) surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Must be PRK Candidate
- What is being tested?
- Fluorometholone(FML) and Loteprednol (Lotemax)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Nov 2017
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female patients, 18-45 yrs of age, in good general health
- PRK candidate(Subjects willing and able to undergo bilateral PRK for the correction of their myopia. )
- Refractive error -1 to -8 diopters (spherical equivalent) at baseline
- Females of childbearing age must have a negative pregnancy test result at baseline. A female considered to be of non-childbearing potential is she is postmenopausal (no menses for 12 consecutive months) or is without a uterus.
- Ability to follow study instructions and likely to complete the entire course of the study(Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period. )
- Written informed consent will be obtained
Show all 9Show fewer
- Written HIPPA authorization will be obtained
- Subjects with MRSE <6.0 D, with less than 2.0 D of astigmatism.
- Stable prescription in both eyes as defined by <0.25 D change over the preceding 2 years.
Who cannot join
- Uncontrolled systemic disease you mean if someone has controlled DM or rheumatic disease can be included
- Any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular pathologies
- History of serious eye disease, trauma, or previous ocular surgery
- History of unstable myopia
- History of herpes keratitis
- Known allergy or hypersensitivity to the study medication
Show all 26Show fewer
- Anticipated wearing of contact lenses in addition to the required bandage contact lens post-PRK. Patients who wear soft contact lenses should discontinue wearing them at least 7 days prior to baseline visit. Patients wearing RGP or hard contact lenses should discontinue wearing them at least 3 weeks prior to baseline visit.
- Females who are pregnant, breastfeeding, or trying to conceive.
- Keratoconus or keratoconus suspect
- Any condition or situation which, in the investigator's opinion, may put patient at significant risk or may confound the study results
- Subjects who have a past or present disease, which as judged by the investigator may affect the safety of the subject or the outcome of the study.
- Subjects who have previously had corneal surgery.
- Subjects with any ocular disease or corneal abnormality, including but not limited to:
- Decreased corneal sensation / neurotrophic cornea;
- Corneal vascularization;
- Keratoconus;
- Keratoconjunctivitis sicca requiring chronic treatment;
- Lagophthalmos;
- Blepharitis;
- History of infectious keratitis;
- History of glaucoma or intraocular pressure of >21 mmHg or use of glaucoma medications;
- Significant dry eye disease that requires regular topical treatment;
- Corneal thickness <480 µm at the thinnest point, and
- Posterior elevation >40 micron.
- Subjects who require any topical ophthalmic medication other than the pre- and postoperative regimen defined in the study protocol.
- Subjects who are taking amiodarone, long acting anticholinergics, e.g., atropine, scopolamine, or medications or agents that can cause dry eye.
Trial locations and contacts
No sites are listed yet.
Payam Peymani, Pharm.D, PhD contact
Mohammadreza Razeghinejad, M.D., Ophthalmologist contact
About this study
Official title: Randomized, Single Blinded Controlled Trial for Evaluation of the Safety and Efficacy of Loteprednol Versus Fluorometholone After Photorefractive Keratectomy for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy (PRK) surgery.
OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for one month, 3 x a day for one month and 2 x a day for one month Study medication will be administered to the randomized eye through post op days according to mention protocol. Visit Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal re-epithelialization).
- Conditions
- Must be PRK Candidate
- Being tested
- Fluorometholone(FML), Loteprednol (Lotemax)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorometholone(FML)Drug
Loteprednol (Lotemax)Drug
| Study group | Role | What they receive |
|---|---|---|
| Fluorometholone(FMl) | Active comparator | Patients will be randomized to the eye and will receive FML in one eye. Receives: Drug: Fluorometholone(FML) |
| Loteprednol (Lotemax) | Active comparator | Patients will be randomized to the eye and will receive Lotemax in contralateral eye. Receives: Drug: Loteprednol (Lotemax) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to re-epithelialization
Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.
Measured: 3-7 days
Secondary outcomes (3)
Time to zero pain
Study subject will complete a questionnaire about their comfort levels at each postoperative visit, up to an including the 3-7 days post op exam.
Measured: 3-7 days
Occurrence of enhancements
Will document the number of requested/recommended enhancement procedures at the 3 month postoperative visit.
Measured: 3 months post operative
Incidence of adverse events
Measured: Day 1 up to day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startApr 2017
- Primary completionAug 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Must be PRK CandidateStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Salouti Eye Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974387
- Sponsor's protocol ID
- SERCCT1
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single Blinded Controlled Trial for Evaluation of the Safety and Efficacy of Loteprednol Versus Fluorometholone After Photorefractive Keratectomy for the Correction of Mild to Moderate Myopia, 3- Month Follow-up Study
- ClinicalTrials.gov ID
- NCT02974387
- Acronym / sponsor ID
- SERCCT1
- Conditions
- Must be PRK Candidate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Dr Salouti Eye Research CenterUniversity, hospital or other
- Collaborators
- Shiraz University of Medical Sciences
- Study start
- Apr 2017
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 28 Nov 2016 (estimated)
- 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.
STUDY OBJECTIVE: To evaluate and compare the safety and efficacy of (corneal Wound Healing and Intraocular Pressure) Fluorometholone and Loteprednol after photorefractive keratectomy (PRK) surgery.
OVERALL STUDY DESIGN: Structure: Single-center, randomized, single blinded, contralateral (one eye receives FML, one eye Lotemax) Treatment Group: Patients will be randomized to the eye and will receive FML in one eye, Lotemax in contralateral eye Duration: 3 months Dosage/Dose Regimen: All patients will receive each one of the steroid agents 4 x a day for one month, 3 x a day for one month and 2 x a day for one month Study medication will be administered to the randomized eye through post op days according to mention protocol. Visit Schedule: baseline-screening, postop days 1, 7, 30 and then month 3th (through corneal re-epithelialization).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluorometholone(FMl) | Active comparator | Drug: Fluorometholone(FML)Patients will be randomized to the eye and will receive FML in one eye. |
| Loteprednol (Lotemax) | Active comparator | Drug: Loteprednol (Lotemax)Patients will be randomized to the eye and will receive Lotemax in contralateral eye. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female patients, 18-45 yrs of age, in good general health
- PRK candidate(Subjects willing and able to undergo bilateral PRK for the correction of their myopia. )
- Refractive error -1 to -8 diopters (spherical equivalent) at baseline
- Females of childbearing age must have a negative pregnancy test result at baseline. A female considered to be of non-childbearing potential is she is postmenopausal (no menses for 12 consecutive months) or is without a uterus.
- Ability to follow study instructions and likely to complete the entire course of the study(Subjects who are able to comply with all study procedures, including wearing a soft bandage contact lens in the immediate postoperative period. )
Key exclusion criteria (26 listed)
- Uncontrolled systemic disease you mean if someone has controlled DM or rheumatic disease can be included
- Any active ocular disease, corneal abnormalities, lid abnormalities, or any ocular pathologies
- History of serious eye disease, trauma, or previous ocular surgery
- History of unstable myopia
- History of herpes keratitis
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 |
|---|---|---|
| Fluorometholone(FML) | Drug | Fluorometholone(FMl) |
| Loteprednol (Lotemax) | Drug | Loteprednol (Lotemax) |
Primary outcome
Time to re-epithelialization
Time frame: 3-7 days
Amount of days it takes for the cornea to re-epithelialize after PRK surgery, will be documented for each eye separately.
3 secondary outcomes
Time to zero pain
Time frame: 3-7 days
Occurrence of enhancements
Time frame: 3 months post operative
Incidence of adverse events
Time frame: Day 1 up to day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
- Individual participant dataSharing planned: No
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.
Payam Peymani, Pharm.D, PhD contact
Mohammadreza Razeghinejad, M.D., Ophthalmologist contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluorometholone(FML) and Loteprednol (Lotemax) in people with Must be PRK Candidate, run by Dr Salouti Eye Research Center.
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 9 inclusion and 26 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 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Payam Peymani, Pharm.D, PhD (peymani.payam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to re-epithelialization (time frame: 3-7 days). 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 28 Nov 2016.