This study is a pilot, exploratory study to check safety and efficacy of DM-28 device, a new medical device intended to treat moderate to severe ocular dryness.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
1 drop in each eye, 4 to 6 times per day
Eurofins Dermscan Poland
Gdansk, Poland
Tu sie Leczy
Gdansk, Poland
Incidence of adverse device effects
Adverse device effects will be evaluated via ocular examination and ocular symptoms after instillation reported by the subjects
Time frame: Day 35
Cornea and conjunctiva staining (Oxford scale) (performance)
Main change from baseline of cornea and conjunctiva staining (Oxford scale form 0 to 15, 15 meaning a worse outcome) in the worse eye
Time frame: Day 35
Far best corrected visual acuity (FBCVA)
Change from baseline of FBCVA
Time frame: Day 35
General safety
Collection and description of ocular and systemic Adverse Events
Time frame: Day 35
Cornea and conjunctiva staining (Oxford scale)
Main change from baseline of cornea and conjunctiva staining (Oxford scale from 0 to 15, 15 meaning a worse outcome) in the contralateral eye
Time frame: Day 35
OSDI (questionnaire)
Main change from baseline of Ocular Surface Disease Index (OSDI) score
Time frame: Day 35
Schirmer test
Main change from baseline of Schirmer test result in the worse eye and contralateral eye
Time frame: Day 35
Tear-Film Break Up Time (TBUT)
Main change from baseline of Tear-Film Break Up Time (TBUT) in the worse eye and contralateral eye
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 35
Conjunctival hyperaemia
Main change from baseline of conjunctival hyperaemia using the McMonnies scale (from 0 to 5, 5 meaning a worse outcome) in the worse eye and contralateral eye
Time frame: Day 35
Global performance by the investigator
Global performance assessment by the investigator using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: Day 35
Global performance by the patient
Global performance assessment by the patient using a 4-point scale (Unsatisfactory, Not very satisfactory, Satisfactory, Very satisfactory)
Time frame: Day 35
Comfort upon device administration
Evaluation of the comfort upon device administration by the patient using a 5-points scale (from very uncomfortable to very comfortable)
Time frame: Day 4, Day 11, Day 18, Day 25, Day 32
Patient satisfaction on device performance
Evaluation of patient satisfaction on 5 Visual Analogical Scales (VAS) from 0 to 100 and calculation of the total score
Time frame: Day 0, Day 7, Day 14, Day 21, Day 28, Day 35