Clinical Trial to Compare the Safety and Efficacy of Nanodrop® (PRO-176/I)
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|ClinicalTrials.gov Identifier: NCT04111965|
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : December 2, 2019
Phase I-II clinical trial, comparative, non-inferiority with active control, parallel groups, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects of the Nanodrop® group, if there are less than 20% of unexpected Events (EA), related to the research product, recruitment is continued until the sample is completed for efficacy analysis
objectives Security: Evaluate the safety of the ophthalmic application of Nanodrop® by quantifying the incidence of unexpected Adverse Events (EA) related to the research product (PI).
Effectiveness: Demonstrate the non-inferiority of Nanodrop® compared to Systane® Balance, in the efficacy of the treatment of patients with dry eye, by means of the Ocular Surface Disease Index (OSDI).
H0 = Nanodrop® is safe in its ophthalmic application as it presents an incidence of unexpected adverse events related to the research drug, less than 20% of the population of Nanodrop® safety group.
H1 = Nanodrop® is not safe in its ophthalmic application, as it presents an incidence of unexpected adverse events related to the research drug, exceeding 20% of the population of Nanodrop® safety group.
H0 = Nanodrop® is lower than Systane® Balance by more than 5 points in the OSDI test score.
H1 = Nanodrop® is lower than Systane® Balance by 5 points or less in the OSDI test score.
Number of subjects: n = 126 evaluable subjects 63 evaluable subjects per group (both eyes).
Main inclusion criteria: Dry eye diagnosis
Duration of intervention treatment: 28 days Approximate duration of the subject in the study: 35 days
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye||Drug: Nanodrop® Drug: Systane Balance||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Phase I-II clinical trial, comparative, non-inferiority with active control, double blind with randomisation. Safety analysis when completing the visits of the first 12 subjects|
|Masking:||Double (Participant, Investigator)|
Masking will be done through the primary and secondary packaging.
They will be identified by means of identical tags. Which, in compliance with current and applicable regulations, must contain at least:
|Official Title:||Phase I-II Clinical Trial to Compare the Safety and Efficacy of Nanodrop® Against Systane® Balance in the Treatment of Dry Eye Patients|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||July 30, 2020|
Experimental: Nanodrop® (PRO-176)
- Nanodrop®. 0.6% propylene glycol. Ophthalmic emulsion Laboratorios Sophia, S.A. from C.V. Route of administration: Ophthalmic.
minimum to meet 1 drop 4 times a day, both eyes
Active Comparator: Systane® Balance
Drug: Systane Balance
minimum to meet 1 drop 4 times a day, both eyes
Other Name: Propylene glycol 0.6%
- Ocular Surface Disease Index (OSDI) [ Time Frame: will be evaluated at the end of the treatment (day 29, final visit) ]OSDI is a questionnaire designed to measure eye surface irritation with Rasch analysis to produce estimates on a linear interval scale (ratings: 0-100). Similar to the index for ocular surface diseases, the ocular comfort index (OCI) evaluates symptoms. It contains items that focus on the discomfort associated with alterations of the ocular surface. Each of these questions has two parts, which concern separately the frequency and severity of symptoms.
- Incidence of unexpected events related to the research product [ Time Frame: during the 29 days of evaluation, including the safety call ]the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
- visual acuity (VA) [ Time Frame: will be evaluated at the end of the treatment (day 29, final visit) ]Visual acuity (VA) is a test of visual function. It will be evaluated at baseline, without refractive correction with the Snellen chart.Which will be located in a place with adequate lighting, natural or artificial and at a distance of 3meters from the subject to be evaluated. The snellen chart consists of a booklet with 11 lines composed of letters, each line has a different size and a different weighting. the subject is placed at a safe distance and the contralateral eye to which it will be evaluated is covered, then the examiner detects until the line can clearly see the letters given he or she a score, the normal score for a VA is 20/20.
- Epithelial Defects (ED) Fluorescein stain [ Time Frame: will be evaluated at the end of the treatment (day 29, final visit) ]The epithelial defects will be evaluated by fluorescein, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA).According to the CTO, grade 0 corresponds to the absence of dotted epithelial erosions (EEP); Grade 1 is defined as the presence of 1-5 EEP; Grade 2 corresponds to 6-30 EEP; and> 30 EEP will be classified as grade 3. Additionally a qualification point will be added if: 1) EEP is presented in the central portion of the cornea with a diameter of 4mm; 2) filaments are observed and 3) confluent staining patches are observed, including linear stains
- epithelial Defects (ED) Green lissamine [ Time Frame: will be evaluated at the end of the treatment (day 29, final visit) ]The epithelial defects will be evaluated by green lissamine, it is a discrete variable that will be realized by direct observation, It will be qualified according to the Eye Staining Rating (CTO) of the International Alliance of Clinical Collaboration of Sjögren (SICCA). In the CTO, grade 0 is defined as the presence of 0 to 9 lissamine green staining points in the interpalpebral bulbar conjunctiva (qualifying the temporal and nasal portion separately); grade 1 is defined by the presence of 10 to 32 points; grade 2 by 33 to 100; and grade 3 for> 100 points. Due to the difficulty of counting individual points in a moving eye, any area ≥ 4mm2 of confluent points is considered> 100 points
- Incidence of expected adverse events [ Time Frame: will be evaluated at the end of the treatment (day 29, final visit) ]the adverse events will be evaluated with a scale of Present / Absent, it is a nominal variable, the normal value is absent
- Tear breakup time (TBUT) [ Time Frame: will be evaluated at the end of the treatment (day 29, final visit) ]
brake up time of the tear film One of the first aspects of the tear film that changes when there is an alteration to the ocular surface is its stability. In general, if the corneal or conjunctival surface is damaged, it is unlikely that a stable tear film can be maintained.
The most common method to evaluate tear film stability is the evaluation of TBUT with fluorescein. Once the fluorescein is instilled, with the cobalt blue filter the patient is asked not to blink after having blinked 1 to 2 times. The colored precorneal fluorescein layer will change to less fluorescent or non-fluorescent regions. The time that elapses from the last blink to the appearance of these regions is the TBUT. It will be reported in seconds.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04111965
|Contact: Ricardo Llamas, PhD||+52 (33) 3001 4200 ext firstname.lastname@example.org|
|Contact: Oscar M. Olvera, MD||+52 (33) 3001 4200 ext email@example.com|
|Study Director:||Leopoldo Baiza Durán, MD||Laboratorios Sophia S.A de C.V.|