Clinical utility of Quantum Molecular Resonance treatment for dry eye disease

Not Applicable

• Conditions: Meibomian gland dysfunction; Aqueous deficiency dry eye; Evaporative dry eye; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12621001187831
• Lead Sponsor: The University of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-03
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Participants with symptomatic dry eye caused by evaporative causes (e.g. meibomian gland dysfunction) or aqueous deficient causes (e.g. Sjögren's syndrome).

Participants will be required to:
• Meet TFOS DEWS II criteria for dry eye diagnosis
• Be willing and able to follow the protocol accurately
• Be willing to minimise application of dry eye treatments beyond the study treatment

TFOS DEWS II dry eye diagnosis:
Adult participants meeting the criteria for dry eye disease according to the TFOS DEWS II diagnostic criteria (symptoms: OSDI greater or equal to 13, DEQ-5 greater or equal to 6; plus one or more signs: non-invasive breakup time (NIBUT) less than 10s, osmolarity greater than 308 or interocular diff of greater or equal to 8; greater than 5 spots corneal staining with NaFl, greater than 9 spots conjunctival staining with lissamine green, lid margin staining (lid wiper epitheliopathy) of greater or equal to 2mm in length and greater or equal to 25% lid margin width will be recruited.

Subclassification according to dry eye status (ADDE, EDE or mixed) and severity (mild-moderate vs moderate-severe) will be determined according to established cut-offs.

For EDE: Clinically significant signs of MGD: (eyelid margin or mucocutaneous junction abnormalities, meibomian gland orifice capping, and/or decreased expressed meibum quality).

For ADDE: reduced tear meniscus height (less than 0.2mm).

Exclusion Criteria

Exclusion Criteria:
• OPAS score greater than 70% on questions 1, 4 or 7 indicating possible ocular neuropathic pain that may be unresponsive to treatment
• Contact lens wear, or application of topical therapies other than dry eye drops within two weeks of the eligibility assessment or during the trial
• Use of systemic medications known to affect the ocular surface or tear production
• Current or planned pregnancy or lactation during the study
• History of major systemic, dermatologic or ocular conditions
• Ocular surgery or dermatologic treatments in the previous three months or planned during the treatment period.
• Unwillingness to refrain from dye drop application on study visit days
• Use of warm compresses or lid hygiene unless applied regularly as part of a stable regime for greater than 3 months and continued throughout trial, but not within 24 hours of study visits
• LipiFlow, IPL (Intense Pulsed Light) or investigational treatment for dry eye disease within 6 months of study start
• Lid debridement or therapeutic meibomian gland expression within 1 month of study start

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in non-invasive tear breakup time (NIBUT) as measured by the Oculus Keratograph 5M.<br>[Measurements will be recorded at baseline, then on 1 month, 2 month, and 3 month follow-up visits after the conclusion of the intervention treatment course (4 treatments performed weekly over a month period).<br><br>Primary timepoint is the 3 month follow-up visit.<br>]