Evaporative Dry Eye DiseasePhase 4NCT06686368
Comparative Efficacy Study to Demonstrate the Non-inferiority of I-DROP® MGD Versus 2 Competitor Eye Drops in Managing Evaporative Dry Eye
A Phase 4 study testing I-DROP MGD, Theloze Duo and Systane Complete PF in people with Evaporative Dry Eye Disease, run by I-MED Pharma.
Trial summary
A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaporative Dry Eye Disease
- What is being tested?
- I-DROP MGD, Theloze Duo and Systane Complete PF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 31 Mar 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and signed an information consent form.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:
- OSDI ≥ 13
- And TBUT < 10 seconds
- And >5 spots of corneal fluorescein staining OR > 9 conjunctival spots
- Meibomian Gland score of 1 or higher using NEI grading criteria.
Who cannot join
- Is participating in any concurrent clinical or research study.
- Is wears contact lenses.
- Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.
- Has undergone eye surgery involving the cornea or conjunctiva.
- Aqueous deficient DED patients.
- Is currently or has used any of the study drops in the last 3 months.
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- Has any known allergy or intolerance to any of the study drops.
- Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease).
- Has known sensitivity to sodium fluorescein.
- Is pregnant, lactating or planning a pregnancy at the time of enrolment?
- Unwilling to stop using their habitual artificial tears for the study.
- Has been fitted with punctal plugs within 30 days before the study screening visit.
- Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Efficacy of I-DROP®MGD Versus Competing Eye Drops in Managing Evaporative Dry Eye: A Pilot Randomized Controlled Trial
A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye
Read the detailed description
Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye
- Conditions
- Evaporative Dry Eye Disease
- Being tested
- I-DROP MGD, Theloze Duo, Systane Complete PF
- Keywords
- Dry Eye Disease, Lubricant eye drops, Meibomian Gland Dysfunction, Evaporative dry eye
- Medical subject headings
- Dry Eye Syndromes, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-DROP MGDDevice
All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
Theloze DuoDevice
All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
Systane Complete PFDevice
All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
| Study group | Role | What they receive |
|---|---|---|
| I-DROP MGD | Experimental | High Molecular weight hyaluronic acid + PC containing lubricant eye drop Receiving lubricant eye drops with high molecular weight hyaluronic acid Receives: Device: I-DROP MGD |
| Thealoz Duo | Active comparator | Low Molecular weight hyaluronic acid + Trehalose containing lubricant eye dropReceiving lubricant eye drops with low molecular weight hyaluronic acid Receives: Device: Theloze Duo |
| Systane Complet PF | Active comparator | No hyaluronic acid containing lubricant eye drop Receiving lubricant eye drops without hyaluronic acid Receives: Device: Systane Complete PF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescein Tear Break-Up Time (FTBUT) in seconds
The primary outcome of the study is FBUT at 30 minutes post-installation
Measured: Day 1 - 30 minutes post installation
Secondary outcomes (5)
Fluorescein Tear Break-Up Time (FTBUT) in seconds
One of the secondary endpoints is FTBUT at day 7 and day 28
Measured: Day 7 - day 28
Tear Meniscus Height (TMH) in milimiters
One of the secondary endpoints is TMH at day 1 (30 minutes post-installation), 7 and day 28
Measured: Day 1 - Day 7 - day 28
Osmolarity in mOsm/L
One of the secondary endpoints is osmolarity at day 1 (30 minutes post-installation), 7 and day 28
Measured: Day 1 - Day 7 - day 28
Number of Corneal and Conjunctival spots
One of the secondary endpoints is Corneal and conjunctival spots at day 7 and day 28
Measured: Day 7 - day 28
Ocular Surface and Disease Index (OSDI) score
One of the secondary endpoints is OSDI score at day 7 and day 28
Measured: Day 7 - day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaporative Dry Eye DiseaseStudies 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
- Model description
- in vivo, human patient with confirmed Evaporative dry eye disease
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I-MED Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686368
- Sponsor's protocol ID
- CR001-2024
- Status last verified
- Nov 2024
- First submitted
- 23 Oct 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of I-DROP®MGD Versus Competing Eye Drops in Managing Evaporative Dry Eye: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06686368
- Acronym / sponsor ID
- CR001-2024
- Conditions
- Evaporative Dry Eye Disease
- Keywords
- Dry Eye Disease, Lubricant eye drops, Meibomian Gland Dysfunction, Evaporative dry eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- I-MED PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 13 Nov 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.
A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye
Detailed description
Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- in vivo, human patient with confirmed Evaporative dry eye disease
| Arm | Type | Receives |
|---|---|---|
| I-DROP MGD | Experimental | Device: I-DROP MGDHigh Molecular weight hyaluronic acid + PC containing lubricant eye drop Receiving lubricant eye drops with high molecular weight hyaluronic acid |
| Thealoz Duo | Active comparator | Device: Theloze DuoLow Molecular weight hyaluronic acid + Trehalose containing lubricant eye dropReceiving lubricant eye drops with low molecular weight hyaluronic acid |
| Systane Complet PF | Active comparator | Device: Systane Complete PFNo hyaluronic acid containing lubricant eye drop Receiving lubricant eye drops without hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and signed an information consent form.
- Is willing and able to follow instructions and maintain the appointment schedule.
- Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye:
Key exclusion criteria (14 listed)
- Is participating in any concurrent clinical or research study.
- Is wears contact lenses.
- Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity.
- Has undergone eye surgery involving the cornea or conjunctiva.
- Aqueous deficient DED patients.
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 |
|---|---|---|
| I-DROP MGDAll drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30 | Device | I-DROP MGD |
| Theloze DuoAll drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30 | Device | Thealoz Duo |
| Systane Complete PFAll drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30 | Device | Systane Complet PF |
Primary outcome
Fluorescein Tear Break-Up Time (FTBUT) in seconds
Time frame: Day 1 - 30 minutes post installation
The primary outcome of the study is FBUT at 30 minutes post-installation
5 secondary outcomes
Fluorescein Tear Break-Up Time (FTBUT) in seconds
Time frame: Day 7 - day 28
Tear Meniscus Height (TMH) in milimiters
Time frame: Day 1 - Day 7 - day 28
Osmolarity in mOsm/L
Time frame: Day 1 - Day 7 - day 28
Number of Corneal and Conjunctival spots
Time frame: Day 7 - day 28
Ocular Surface and Disease Index (OSDI) score
Time frame: Day 7 - day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing I-DROP MGD, Theloze Duo and Systane Complete PF in people with Evaporative Dry Eye Disease, run by I-MED Pharma.
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 8 inclusion and 14 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: opening soon, as of the sponsor's last update on 13 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Fahmy, Ph.D. (1-800-463-1008, kfahmy@imedpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluorescein Tear Break-Up Time (FTBUT) in seconds (time frame: Day 1 - 30 minutes post installation). 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 13 Nov 2024.