CLINICAL INVESTIGATION ON THE USE OF PHTHALMIC SOLUTION BASED ON HYALURONATE SODIUM PHOSPHATE IN TREATMENT OF EYE DISCOMFORT
Study Details
Study Description
Brief Summary
The puropose of this study is to assess the performance and safety resulting from the treatment of an ophthalmic solution for the ocular discomfort and in particular in presence of ocular dryness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Multicenter, prospective, observational, open-label, non- interventional clinical investigation evaluating the performance and safety of 4 daily instillations of the ophthalmic solution in the treatment of mild irritation of the ocular surface.
Study Design
Outcome Measures
Primary Outcome Measures
- Tear film break-up time with fluorescein (TFBUT) [Evaluated at day 35 ± 4 of treatment versus baseline]
30% increase of Tear film break-up time with fluorescein (TFBUT)
Secondary Outcome Measures
- Fluorescein staining [Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline]
Evaluation of the change in total score resulting from the sum of the corneal staining score and conjunctival. staining score with fluorescein using the National Eye Institute Scale (NEI)
- SANDE [Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline]
Change in intensity and frequency of dry eye symptoms assessed by completing the questionnaire SANDE.
- Patients satisfaction (0 to 100 mm on the VAS scale) [Evaluated at day 35 ± 4 of treatment]
Evaluation of the degree of satisfaction to the treatment reported by patients through the use of the visual analogue scale (VAS)
- Assessment of the quality of life (QOL) [Evaluated at baseline and day 35 ± 4 of treatment]
Assessment of the quality of life (QOL) by "Questionnaire about Eye Symptoms and Daily Life" (DEQS) at Study Termination Visit compared to Visit 1
- Tear film break-up time with fluorescein (TFBUT) [Evaluated at day 14 ± 2 of treatment versus day 35 ± 4 of treatment]
Evaluation of the change in total score resulting from the sum of the corneal staining score and conjunctival. staining score with fluorescein using the National Eye Institute Scale (NEI)
- Best Corrected Visual Acuity (BCVA) [Evaluated at day 14± 2 and 35 ± 4 of treatment versus baseline]
Changes about Best Corrected Visual Acuity (BCVA) measured by the "Early Treatment Diabetic Retinopathy Study" (ETDRS)
- Investigator Global Assessment of Safety (IGAS) [Evaluated at day 35 ± 4 of treatment]
Investigator Global Assessment of Safety (IGAS): using the 4-point scale:1= very good safety, 2 =good safety, 3 = moderate safety and 4 = poor safety.
- Assess safety [During the treatment period]
Evaluation of reported adverse effects/incidents
- Evaluation of intraocular pressure (IOP) [Evaluated at baseline, day 14± 2 and 35 ± 4 of treatment]
Evaluation of intraocular pressure (IOP)
- Evaluation of compliance [Evaluated at baseline and at day 35 ± 4 of treatment]
Evaluation of compliance through verification of correct instillation of the medical device, counting of single dose containers and boxes
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects (male or female) must be ≥ 18 years of age;
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Subject able to provide Informed Consent, in compliance with the good clinical practice and local laws (thus, subject able to comprehend the full nature and purpose of the study, including possible risks and side effects);
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Subjects with ocular discomfort resulting from mild to moderate dry eye in one or both eyes determined by:
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Scoring of ocular surface staining with fluorescein using the National Eye Institute (NEI) scale. Total score per single eye range 6-33 summing the score of cornea and conjunctiva. (Considering a normal score of 0-33);
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Tear film break-up time with fluorescein (TFBUT) ≤ 10 seconds; The TFBUT value will be recorded as the average of 3 measurements;
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Symptom Assessment in Dry Eye (SANDE) questionnaire ≥ 35.
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Subject able to be compliant with the requirements of the clinical investigation plan, according to the Investigator;
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Subject who qualifies for Hyalistil Bio PF treatment according to the approved indication;
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Subject who in physician's opinion will benefit from this treatment.
Exclusion Criteria:
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Corneal injuries or abrasions of traumatic origin in the eye of study;
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Ocular infection or clinically significant inflammation (such as Herpes Simplex infection, corneal virus infection, bacterial, viral or fungal conjunctivitis, tuberculosis and mycosis of the eye, purulent and herpetic blepharitis, stye);
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Sjögren's syndrome;
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Stevens-Johnson syndrome;
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Systemic lupus erythematosus;
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Pathologies associated with corneal thinning;
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Taking drugs that may interfere with tear gland secretion (beta -blockers);
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Patients using any topical therapies such as non-steroidal antiinflammatory drugs, cortisone, cyclosporine, vasoconstrictor, artificial tears (different than the investigated product) the eye of study;
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Treatment with topical or systemic corticosteroids in the 4 weeks preceding the study;
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Known or potential hypersensitivity and/or history of allergic reactions to one of the components of the topical medical device.
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Participation in another clinical trial within the previous 30 days;
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Evidence of severe or uncontrolled systemic disease or any other significant disorders, which in the opinion of the Investigator does not allow the participation in the study or could compromise the results.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | P.O. San Marco, Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" Oculistica, | Catania | CT | Italy | 951251 |
| 2 | U.O. di Oculistica, Presidio Belmonte, Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone" | Palermo | Italy | 90142 |
Sponsors and Collaborators
- SIFI SpA
Investigators
- Principal Investigator: Davide Scollo, M.D., U.O.S. Oculistica "San Marco" A.O.U. Policlinico "G.Rodolico-San Marco" Catania, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 052/SI Hyalistil Bio PF Mono