This is a multicenter, prospective, observational, open-label, non-interventional study evaluating the clinical performance and the safety of 4 daily instillations of the ophthalmic solution in the treatment of eye discomfort, in particular due to eye dryness
Primary objective ▪ To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline. Secondary objectives * To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the NEI scale after 14 days of treatment and after 3 months of treatment compared to baseline. * To evaluate conjunctival hyperemia index assessed by OCULUS Keratograph after 14 days, 1 month and 3 months of treatment compared to baseline. * To evaluate the tear film stability as objectified by the tear film break-up time (TFBUT) test after 14 days, 1 month and 3 months of study treatment initiation compared to baseline. * To evaluate the changes on the Best Corrected Visual Acuity (BCVA) measured by the "Early Treatment Diabetic Retinopathy Study" (ETDRS) after 14 days, 1 month and 3 months of study treatment initiation compared to baseline. * To compare patients reported outcomes with baseline, using specifically: * the patient's reported Symptom Assessment questionnaire iN Dry Eye (SANDE) after 1 and 3 months of treatment; * the patient's Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire after 1 and 3 months of treatment. * To evaluate the safety and compliance of the medical device throughout the entire study period.
Study Type
OBSERVATIONAL
Enrollment
35
Instillation of study drug in both eyes: preservative-free ophthalmic solution based on sodium hyaluronate and xanthan gum
Oftalvist
Alicante, Spain
Hospital Arruzafa
Córdoba, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital Nuestra Señora de Gracia
Zaragoza, Spain
Keratitis lesions
To evaluate the clinical performance of Eyestil SYNFO® as detected by the reduction of keratitis lesions objectified by corneal and conjunctival staining tests with fluorescein using the National Eye Institute (NEI) scale after 1 month of treatment compared to baseline.
Time frame: 1 month
Keratitis Lesions
To evaluate the mean change of the corneal and conjunctival staining score with fluorescein using the National Eye Institute scale compared to baseline.
Time frame: Day 14 and at 3 months
Conjuctival Hyperemia
To evaluate conjunctival hyperemia index by OCULUS keratograph
Time frame: Day 14, 1 month and 3 months
Best Corrected Visual Acuity
To evaluate changes in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score.
Time frame: Day 14, 1 month and 3 months
Tear Film Stability Break-Up time
The conjunctival tear film stability break-up time (TFBUT) will be evaluated after the instillation of 5 µl of a 2% preservative-free sodium fluorescein solution into the inferior conjunctival cul-de-sac- of each eye. The TFBUT value will be the average of 3 measurements.
Time frame: Day 14, 1 month and 3 months
SANDE Questionnaire
To compare patients reported outcomes with baseline, using the Symptom Assessment questionnaire iN Dry Eye (SANDE) questionnaire
Time frame: 1 and 3 months
DEQS Questionnaire
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To compare patients reported outcomes with baseline, using the Dry Eye-Related Quality-of-Life Score (DEQS) questionnaire
Time frame: 1 and 3 months
Number of Adverse Events
To evaluate the safety through general assessment of adverse events
Time frame: From date of randomization up to 3 months
Investigator Global Assessment Score
To evaluate the safety using the Investigator Global Assessment Score
Time frame: From date of randomization up to 3 months
Intra Ocular Pressure
To evaluate the safety using the measurement of the intraocular pressure
Time frame: From date of randomization up to 3 months
Number and status (empty/unused) of returned devices
To evaluate compliance based on treatment administration and returned medical devices
Time frame: Day 14, 1 month and 3 months