NCT05741398
Recruiting
Not Applicable
Evaluation of the Efficacy and Safety of Optical System in the Treatment of - Dry Eye Disease (DED) Pilot Study
Demaod Ltd1 site in 1 country15 target enrollmentStarted: June 1, 2023Last updated:
ConditionsDry Eye Syndromes
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Demaod Ltd
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 4 weeks TBUT change from baseline
Overview
Brief Summary
Single-center, Prospective, Open Label, with Before-After Study Design, to evaluate the safety and efficacy of the optical system in the treatment of dry eye disease.
Detailed Description
Single-center, Prospective, Open Label, with Before-After Study Design. Up to 15 subjects will be enrolled in the study to provide at least 10 evaluable subjects.
All subjects will undergo 3 treatments two weeks apart (2 weeks (+/-3 days) from the previous treatment).
Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
no masking during this study.
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years and older of any gender or race.
- •Provide written informed consent before study participation.
- •Willingness and ability to return for all study visits.
- •Ocular Surface Disease Index (OSDI) questionnaire and a score of ≥ 23 at the baseline visit.
- •Tear break-up time (TBUT) \<10 seconds in both eyes.
- •Agreement/ability to abstain from dry eye/MGD medications for the time between the treatment visit/s and the final study visit. Ocular lubricants are allowed if no changes are made during the study.
- •History of ocular surgery including intraocular, oculoplastic, corneal or refractive surgery within 1 year.
- •Patients with giant papillary conjunctivitis.
- •Patients with punctal plugs or who have had punctal cautery.
- •Ocular injury or trauma, chemical burns, or limbal stem cell deficiency within 3 months of the baseline examination.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
4 weeks TBUT change from baseline
Time Frame: up to 4 weeks post last treatment
Change from baseline to the 4-week follow-up exam in Tear Break Up Times (TBUT), as assessed by a rater.
Secondary Outcomes
- OSDI changes from baseline to 4 and 12 weeks FU(up to 12 weeks post last treatment)
- 12 weeks TBUT change from baseline(12 weeks post last treatment)
Investigators
Study Sites (1)
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