Dry EyePhase 4NCT05159284
Efficacy and Safety of Topical Hydrocortisone on Signs and Symptoms of Dry Eye Associated to Meibomian Gland Dysfunction
A Phase 4 study testing Hydrocortisone Ophthalmic, MGD Rx EyeBag® eyelid warming device and Lephanet® lid wipes in people with Dry Eye and Meibomian Gland Dysfunction, run by Laboratorios Thea, Spain at 1 site in Spain.
Trial summary
The purpose of this study is assess the efficacy and safety of topical hydrocortisone (Softacort) for treatment of clinical signs and symptoms of dry eye disease when associated with moderate meibomian gland dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Meibomian Gland Dysfunction
- What is being tested?
- Hydrocortisone Ophthalmic, MGD Rx EyeBag® eyelid warming device and Lephanet® lid wipes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteSpain
- Study dates
- 9 Nov 2021to Mar 2025
- 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
- Age ≥ 18 years
- Documented diagnosis of DE defined by TBUT value ≤ 5 seconds and Schirmer I test value < 10 mm/5 min
- Normal ophthalmic findings except dry eye disease and meibomian gland dysfunction
- OSDI score > 23 (moderate symptoms)
- Documented diagnosis of MGD grade 2 to 3
- Patient who can understand the instructions and adhere to medications
- Patient who receives complete information regarding the study objectives, authorize their participation in the study and sign an informed consent form before entering in the study
Who cannot join
- Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag® or Softacort®
- Ocular surgery in the past 6 months
- Ocular hypertension or glaucoma
- Cicatricial MGD
- Atopic condition including ocular allergy
- Suspect demodex lid infestation as evidenced by the presence of collarettes
Show all 19Show fewer
- Intraocular inflammation
- Confirmed infection with COVID-19 in the last 3 months
- Systemic autoimmune disorder
- Use of contact lenses during the month prior to inclusion in the study or during the study
- Punctal occlusion
- Intraocular pressure > 22 mmHg
- Patient who has received topical or systemic anti-inflammatory treatments including corticosteroids and nonsteroidal anti-inflammatory drugs (NSAIDS) within 3 months prior to be included in the study or with a prescription for receiving topical / systemic anti-inflammatory treatments for the next 3 months
- In the investigator´s opinion, use of systemic medications that could affect the function of the meibomian gland and tear production within 3 months prior to be included in the study
- Any ocular or systemic disease known to affect the tear film other than MGD
- Patient with any situation or state that in the opinion of the investigator discourages their participation in the study
- Patient participating in any other interventional or non-interventional study or who have participated in another study within 30 days prior to inclusion in this study
- Women who are pregnant, planning to become pregnant or breastfeeding
- Patient who will not be able to complete the study (e.g., not willing to attend the follow-up visits, way of life interfering with compliance)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital La Fe
Valencia, 46026
Ana Hervas, MD, +34 961244063, fom@gva.es
About this study
Official title: Prospective Evaluation of the Efficacy and Safety of Topical Hydrocortisone Treatment on Clinical Signs and Symptoms of Dry Eye Disease Associated With Moderate Meibomian Gland Dysfunction
The purpose of this study is assess the efficacy and safety of topical hydrocortisone (Softacort) for treatment of clinical signs and symptoms of dry eye disease when associated with moderate meibomian gland dysfunction.
Read the detailed description
This is a prospective, interventional, randomized (1:1), single blind, of parallel groups and two treatment arms clinical trial (phase IV).
All patients diagnosed with dry eye disease (DED) associated with moderate MGD may participate in the study if they meet all the selection criteria.
Patients (or their representatives) will provide informed consent (IC) prior to the enrolment in the study and to the start of data collection. Patients must meet all the inclusion criteria and not meet any of the exclusion criteria.
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Being tested
- Hydrocortisone Ophthalmic, MGD Rx EyeBag® eyelid warming device, Lephanet® lid wipes, Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%
- 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.
Hydrocortisone OphthalmicDrug
Also called Softacort®
1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop, for a total of 14 days of treatment. Repeat on day 28: 1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop. Patients in the intervention arm will receive two 14-day cycles of hydrocortisone.
MGD Rx EyeBag® eyelid warming deviceDevice
Also called Blepha EyeBag®
Eyelid warming device used once daily for 10 minutes followed by lid massage for 12 weeks by patients in both control and intervention arm.
Lephanet® lid wipesDevice
Also called Blephaclean®
Lid hygiene with Lephanet® lid wipes used twice daily for 3 weeks followed by once daily for 9 more weeks by patients in both control and intervention arm.
Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%Device
Artificial tear supplementation with Thealoz Duo® 4 times daily for 12 weeks by patients in both control and intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag® Receives: Drug: Hydrocortisone Ophthalmic; Device: MGD Rx EyeBag® eyelid warming device; Device: Lephanet® lid wipes; Device: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15% |
| Control group | Other | Lephanet® Thealoz Duo® MGD Rx EyeBag® Receives: Device: MGD Rx EyeBag® eyelid warming device; Device: Lephanet® lid wipes; Device: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy endpoint: Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) at 14 days
Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) calculated by the sum of the Visual Analogue scale (VAS) score assigned by the patient on a scale from 0 (no symptoms) to 100 (worst symptoms) in the following symptoms: itching, dry eye sensation, burning, foreign body sensation and ocular redness.
Measured: Day 0 and Day 14
Safety endpoint: Incidence of increased intraocular pressure and change from baseline at Day 0, Day 14, Day 28 and Day 84
Mean of 3 measures of intraocular pressure measured with Goldmann tonometer in each eye on Day 0, Day 14, Day 28 and Day 84. Increased intraocular pressure defined as >21 mmHg.
Measured: Day 0, Day 14, Day 28 and Day 84
Secondary outcomes (17)
Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire at Day 14, Day 28 and Day 84
12-item questionnaire related to vision-related function, ocular symptoms, and environmental triggers of dry eye. Response on a 0 to 4 scale that ranges from "none of the time" to "all of the time". The final score is calculated by multiplying the sum of all the scores by 25 and then dividing the total by the number of questions answered. Scores range from 0 to 100 with 0 to 12 representing normal, 13 to 22 mild DED, 23 to 32 moderate DED, and 33 severe DED
Measured: Day 0, Day 14, Day 28 and Day 84.
Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score at Day 14, Day 28 and Day 84
Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) calculated by the sum of the VAS score assigned by the patient on a scale from 0 (no symptoms) to 100 (worst symptoms) in the following symptoms: itching, dry eye sensation, burning, foreign body sensation and ocular redness.
Measured: Day 0, Day 14, Day 28 and Day 84.
Change from baseline in ocular symptoms Visual Analogue scale (VAS) questionnaire at Day 14, Day 28 and Day 84
VAS score assigned by the patient on a scale from 0 (no symptoms) to 100 (worst symptoms) in each of the following symptoms: itching, dry eye sensation, burning, foreign body sensation, ocular redness, ocular fatigue, and blurry vision.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in hyperemia score (McMonnies-Chapman scale) at Day 14, Day 28 and Day 84.
Inferior conjunctival hyperemia will be estimated by comparison with the photographic conjunctival hyperemia reference scale covering six grades, with highest grade as worst hyperemia.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Tear break up time (TBUT) at Day 14, Day 28 and Day 84
Number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film observed with slit-lamp after instillation of fluorescein. A TBUT under 10 seconds is considered abnormal
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in corneal and conjunctival staining with fluorescein (Oxford grading scale) at Day 14, Day 28 and Day 84
After instillation of fluorescein in conjunctival sac a comparison to the Oxford chart panels A to E, with E being the worst outcome.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in corneal and conjunctival staining with lissamine green (Van Bijsterveld scale) at Day 14, Day 28 and Day 84
Scoring system that divides the ocular surface into three zones: nasal bulbar conjunctiva, temporal bulbar conjunctiva, and cornea. Each zone is evaluated on a scale of 0 to 3, with 0 indicating no staining and 3 indicating confluent staining; the maximum possible worse outcome score with this system is 9.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in meniscus height at Day 14, Day 28 and Day 84
Measured with anterior segment optical coherence tomography. The lower the tear meniscus height the worst outcome.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Schirmer I test at Day 14, Day 28 and Day 84
Folded edge Schirmer strip is placed over the rim of the lower eyelid and the eyes are then lightly closed. The amount of wetting after 5 minutes on the strip is measured in mm. Normal more than 10 mm / 5 min
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in MGD grading at Day 14, Day 28 and Day 84
Grading of MGD: 0 to 4 where 0 is no meibomian gland dropout and expressed meibum with clear appearance and 4 is with gland dropout of more than half the lid margin or complete keratinization of the ducts and no expression of meibum. Higher grade is a worse outcome.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in lid abnormalities at Day 14, Day 28 and Day 84
Lid margin irregularity (presence or absence), thickness, and plugging of the meibomian orifices. A scale from 0 to 2, with 0 = no findings, 1 = mild findings, and 2 = severe findings.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Eyelid telangiectasia score at Day 14, Day 28 and Day 84
Eyelid telangiectasia score from 0 to 3, where 0 is no findings and 3 is severe findings.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Lissamine green staining score at Day 14, Day 28 and Day 84
Mean of longitudinal staining of upper lid margin after instilation with lissamine green graded from 0 to 3 and sagittal staining graded from 0 to 3 estimated by comparison with standard chart. Higher grade is a worse outcome.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Meibomian gland expressibility score at Day 14, Day 28 and Day 84
Express each of 5 glands in temporal, central and lower lid and grade each gland on a scale from 0 to 3, with 3 = clear liquid secretion, 2 = cloudy liquid secretion, 1 = inspissated / toothpaste consistency, and 0 = no secretion. Total score range from 0 to 45. A lower grade is a worse outcome.
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in tear inflammatory cytokines at Day 14
Levels of 8 inflammatory cytokines in tears will be determined 2 micro liter samples taken from each eye.
Measured: Day 0 and Day 14.
Incidence of adverse events and serious adverse events occurred during the study.
Report of any untoward medical occurrence in a patient during the study
Measured: Day 0, Day 14, Day 28 and Day 84
Change from baseline in ETDRS visual acuity at Day 14, Day 28 and Day 84
Best corrected visual acuity in each eye measured with the ETDRS optotype.
Measured: Day 0, Day 14, Day 28 and Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start9 Nov 2021
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Phase IV, interventional, prospective, randomized, single blind, of parallel groups with two treatment arms clinical trial in one center.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Thea, Spain
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ana Hervas Ontiveros, Dr, Principal investigator, anheront@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159284
- Sponsor's protocol ID
- THEA_HLF_1/21
- Status last verified
- Mar 2024
- First submitted
- 25 Oct 2021
- Last updated
- 13 Mar 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of the Efficacy and Safety of Topical Hydrocortisone Treatment on Clinical Signs and Symptoms of Dry Eye Disease Associated With Moderate Meibomian Gland Dysfunction
- ClinicalTrials.gov ID
- NCT05159284
- Acronym / sponsor ID
- THEA_HLF_1/21
- Conditions
- Dry Eye, Meibomian Gland Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Laboratorios Thea, SpainIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 Dec 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.
The purpose of this study is assess the efficacy and safety of topical hydrocortisone (Softacort) for treatment of clinical signs and symptoms of dry eye disease when associated with moderate meibomian gland dysfunction.
Detailed description
This is a prospective, interventional, randomized (1:1), single blind, of parallel groups and two treatment arms clinical trial (phase IV).
All patients diagnosed with dry eye disease (DED) associated with moderate MGD may participate in the study if they meet all the selection criteria.
Patients (or their representatives) will provide informed consent (IC) prior to the enrolment in the study and to the start of data collection. Patients must meet all the inclusion criteria and not meet any of the exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Phase IV, interventional, prospective, randomized, single blind, of parallel groups with two treatment arms clinical trial in one center.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Hydrocortisone Ophthalmic, Device: MGD Rx EyeBag® eyelid warming device, Device: Lephanet® lid wipes, Device: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%Softacort® Lephanet® Thealoz Duo® MGD Rx EyeBag® |
| Control group | Other | Device: MGD Rx EyeBag® eyelid warming device, Device: Lephanet® lid wipes, Device: Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%Lephanet® Thealoz Duo® MGD Rx EyeBag® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Documented diagnosis of DE defined by TBUT value ≤ 5 seconds and Schirmer I test value < 10 mm/5 min
- Normal ophthalmic findings except dry eye disease and meibomian gland dysfunction
- OSDI score > 23 (moderate symptoms)
- Documented diagnosis of MGD grade 2 to 3
Key exclusion criteria (19 listed)
- Any contraindication or known allergies to Lephanet®, Thealoz Duo®, MGD Rx EyeBag® or Softacort®
- Ocular surgery in the past 6 months
- Ocular hypertension or glaucoma
- Cicatricial MGD
- Atopic condition including ocular allergy
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 |
|---|---|---|
| Hydrocortisone OphthalmicAlso: Softacort®1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop, for a total of 14 days of treatment. Repeat on day 28: 1 drop 4 times daily for 12 days, followed by twice daily for 2 days and stop. Patients in the intervention arm will receive two 14-day cycles of hydrocortisone. | Drug | Intervention group |
| MGD Rx EyeBag® eyelid warming deviceAlso: Blepha EyeBag®Eyelid warming device used once daily for 10 minutes followed by lid massage for 12 weeks by patients in both control and intervention arm. | Device | Control group, Intervention group |
| Lephanet® lid wipesAlso: Blephaclean®Lid hygiene with Lephanet® lid wipes used twice daily for 3 weeks followed by once daily for 9 more weeks by patients in both control and intervention arm. | Device | Control group, Intervention group |
| Thealoz Duo® artificial tear with trehalose 3% and sodium hyaluronate 0.15%Artificial tear supplementation with Thealoz Duo® 4 times daily for 12 weeks by patients in both control and intervention arm. | Device | Control group, Intervention group |
Primary outcome
Efficacy endpoint: Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) at 14 days
Time frame: Day 0 and Day 14
Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) calculated by the sum of the Visual Analogue scale (VAS) score assigned by the patient on a scale from 0 (no symptoms) to 100 (worst symptoms) in the following symptoms: itching, dry eye sensation, burning, foreign body sensation and ocular redness.
Safety endpoint: Incidence of increased intraocular pressure and change from baseline at Day 0, Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Mean of 3 measures of intraocular pressure measured with Goldmann tonometer in each eye on Day 0, Day 14, Day 28 and Day 84. Increased intraocular pressure defined as >21 mmHg.
17 secondary outcomes
Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84.
Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84.
Change from baseline in ocular symptoms Visual Analogue scale (VAS) questionnaire at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in hyperemia score (McMonnies-Chapman scale) at Day 14, Day 28 and Day 84.
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Tear break up time (TBUT) at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in corneal and conjunctival staining with fluorescein (Oxford grading scale) at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in corneal and conjunctival staining with lissamine green (Van Bijsterveld scale) at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in meniscus height at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Schirmer I test at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in MGD grading at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in lid abnormalities at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Eyelid telangiectasia score at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Lissamine green staining score at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in Meibomian gland expressibility score at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in tear inflammatory cytokines at Day 14
Time frame: Day 0 and Day 14.
Incidence of adverse events and serious adverse events occurred during the study.
Time frame: Day 0, Day 14, Day 28 and Day 84
Change from baseline in ETDRS visual acuity at Day 14, Day 28 and Day 84
Time frame: Day 0, Day 14, Day 28 and Day 84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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. This study is not recruiting at the moment.
Ana Hervas Ontiveros, Dr principal investigator
anheront@gmail.com
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 Hydrocortisone Ophthalmic, MGD Rx EyeBag® eyelid warming device and Lephanet® lid wipes in people with Dry Eye and Meibomian Gland Dysfunction, run by Laboratorios Thea, Spain at 1 site in Spain.
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 7 inclusion and 19 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 13 Mar 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 Spain. 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 Maria Beatriz Greaves, Dr (+34934766810 ext. 126, maría.greaves@theapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy endpoint: Change from baseline in Meibomian Gland Dysfunction Dry Eye symptom score (MGD-DE) at 14 days (time frame: Day 0 and Day 14). The study lists 2 primary outcomes in all. 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 Mar 2024.