An observational study in Skin Laxity and Meibomian Gland Dysfunction, sponsored by Ophthalmic Consultants of Long Island. Status unknown at 1 site in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-12.
Sponsored by Ophthalmic Consultants of Long Island · Observational
Among 63 studies in Meibomian Gland Dysfunction with a site in United States — 7 open to participants now, 10 under way, none of them phase 3. Meibomian Gland Dysfunction · United States.
Among the 63 studies in Meibomian Gland Dysfunction with a site in United States, this one is one of 3 that started in 2017, is one of 2 observational ones, and was the 22nd registered.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
Browse Meibomian Gland Dysfunction studies →7 of the 63 studies in Meibomian Gland Dysfunction with a site in United States are open now. Recruiting first, the newest first:
Cleveland Eye Clinic · Sites in United States
University of Alabama at Birmingham · Sites in United States
University of California, Berkeley · Sites in United States
University of Houston · Sites in United States
Illinois College of Optometry · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Meibomian Gland Dysfunction studies recruiting now, 10 (77%) set no upper age limit and 1 (8%) stop at 75 or younger; 1 take children under 18; 1 take healthy volunteers.
This study: 40 Years to 70 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 11 · Phase 4 7
First in 2008; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 65 across 25 observational studies indexed under Meibomian Gland Dysfunction.
Median enrollment 44 across the 61 interventional studies, 33 across the 2 observational. Of the 44 that completed or were terminated, 29 (66%) have results posted.
This tab as a report to print or save as PDF → With an account.
29 of 63 have an industry lead sponsor. The 10 most frequent:
Ophthalmic Consultants of Long Island is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Ophthalmic Consultants of Long Island has 1 study filed under Meibomian Gland Dysfunction — fewer than ten, so there is no comparison to draw.
6 of the studies in Meibomian Gland Dysfunction with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07928986Cleveland Eye ClinicA Multi Center Evaluation of TearCare on Surgical Measurements Before Cataract Surgery | 2026-12 |
| NCT07229001Illinois College of OptometryTreating Meibomian Gland Disease in a Pediatric Population | 2026-12-30 |
| NCT07606625University of California, BerkeleyOcular Surface Health and Tear Film Stability With a Nasal Spray Dry Eye Treatment | 2026-12-31 |
| NCT07224529University of Alabama at BirminghamEfficacy of Vevye Ophthalmic Solution for the Treatment of Meibomian Gland Dysfunction | 2027-02-01 |
| NCT07579156University of Alabama at BirminghamTearCare in Young Adults | 2027-08-01 |
Among the 63 studies in Meibomian Gland Dysfunction with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This protocol will evaluate THERMIeyes® for its ability to treat periorbital skin laxity and wrinkles and monitor ocular surface changes and their effect on evaporative dry eye associated with MGD.
Subjects with skin laxity and evaporative dry eye will be recruited for enrollment in this study. Subjects must present with subjective and objective indicators for periorbital skin laxity and wrinkle grade of 2 or greater out of a 4 point scale. To qualify, subjects must present with high symptoms score on subjective Ocular Surface Disease Index© (OSDI©) Questionnaires (scores≥ 15); Rapid Tear Break up (\< 5 seconds) and Grade ≥ 1 of Flourescein Staining in one area of the cornea. Each of these parameters are to be assessed prior to treatment and at each follow up visit. Treatment is to be performed on periorbital skin only around one eye of the subject using the THERMIeyes® standard protocol. This may result in some redness of the periorbital skin. Subjects are to be seen and treated 2-3 weeks apart for a total of 3 treatments. Subjects will be followed at 6 and 12 weeks after the final treatment. A Validated Grading Scale for Crow's Feet will be used to evaluate changes in skin wrinkles and dry eye signs and symptoms scores will be compared with pre-treatment findings.
Subjects presenting with a Crow Feet Grading score of 2 or greater for skin laxity around their periorbital area and an OSDI score of 15 or greated
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who present with signs of skin laxity \& evaporation dry eye will receive 3 treatments with the THERMIeyes® 20 RF System and monitored for improvements in the conditions for which they have presented.
Device: THERMIeyes® 20 RF System
The masked evaluating physician will be blinded as to which eye is treated. The evaluation on all visits will be performed on both eyes by the masked physician who will not know which eye has been treated with the THERMIeyes® 20 RF System. The treating technician will be aware of the treated eye so as to ensure all treatments are performed to the same eye.
Skin Laxity
Subjective and Objective improvement in skin laxity and wrinkles using the validation Grading Scale for Crow's Feet • To identify an improvement in the signs of dry eye defined as a decrease in total corneal staining after treatment compared with pre-treatment findings.
Time frame: 5 Months
Ocular Surface changes
Improvement in dry eye symptoms defined by a decrease in the OSDI score by 25% and decrease in total corneal staining
Time frame: 3 Months
Plan to share: No — We will not be sharing individual participant data with other researchers but do plan to present the total findings of the study.
No publications or documents are linked to this record.
Started Jul 2017 (actual). Primary completion is estimated for Jul 2018, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ophthalmic Consultants of Long Island