Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT06004895
Eligibility Criteria:
Inclusion Criteria:
* Individuals with dry eye disease symptoms (Ocular Surface Disease Index questionnaire (OSDI) score ≥ 13 or Dry Eye Questionnaire (DEQ5) score \> 6) and signs (tear film instability measured with non-invasive tear break-up time \< 10 s or ocular surface damage measured using special dyes placed on the front surface of the eyes that temporarily stains any aggravated or damaged cells: \> 5 corneal spots, \> 9 conjunctival spots or lid margin staining ≥ 2mm in length and ≥ 25% in width) (Wolffsohn et al., 2017)
* Individuals need to also have Meibomian gland dysfunction. The diagnosis of Meibomian gland dysfunction depends on how many of 5 glands in the central lower eyelid can express oil, and the quality of the oil. A diagnosis is made if there is decreased expressibility (grade 1-3 on the Pflugfelder scale) and reduced quality of oil (grade 1-3 on Bron scale). Any presence of gland blockage and/or loss of oil glands grade 2 to grade 4 of either eyelid \[Pult and Reide-Pult, 2013\]) will also justify a diagnosis of Meibomian gland dysfunction
* Age ≥ 18 years, male or female
* Able to provide written consent in English
* Able to attend multiple visits (4 treatment visits) and followed up for 2 weeks and 3 months after final treatment
Exclusion Criteria:
* Pregnancy
* Contraindications to IPL treatment (Individuals with darker skin types - Fitzpatrick skin type V or VI, photosensitive epilepsy, tattoos, implants, electrical or acoustic prosthetics, semi-permanent make-up, pigmented lesions or skin cancer in the treatment area, pacemakers, use of photosensitising medication the past 3 months or during treatment period)
* Facial or ocular IPL or LLLT treatment within the past 6 months or during study period in addition to those provided in the study
* Use of topical medical eyedrops in the past 3 months or during study period
* Contact lens wear in the past 2 weeks or during study period
* Systemic conditions that can cause dry eye disease or corneal nerve loss including diabetes and Sjögren's syndrome
* Other active ocular surface diseases or history of ocular surgery or corneal infections
* Individuals with 1 eye
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06004895
Study Brief:
Protocol Section:
NCT06004895