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The purpose of this study is to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®
Dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Current treatment is heavily weighted toward supplementation, stimulation, or preservation of aqueous tears. Artificial tears are one of the primary treatments for dry eye; it is mainly palliative and focuses on reducing the symptoms of discomfort to improve quality of life for a patient.
A phase III randomized double-blind clinical trial will be conducted to evaluate efficacy and safety of the ophthalmic solution PRO-148 in the ocular surface of patients with mild to moderate dry eye compared with ophthalmic solution Systane®. Patients will be randomized to receive one of the treatments for 60 days. Efficacy and safety measures will be performed at baseline and at 60 days after treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO-148 | Experimental | PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day |
|
| Systane® | Active Comparator | Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-148 | Drug | Instill 1 drop in each eye four times a day, for 60 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Surface Disease Index (OSDI©) Questionnaire | Ocular Surface Disease Index (OSDI©) questionnaire , consists of 12 questions divided in 3 groups, Each question has a value that can go from 0 to 4 points according to the severity of the case: 0.None of the time, 1. Some of the time, 2.Half of the time, 3.most of the time and 4 all of the time. The points of all the questions will be used in the following formula for converted to a score of 0-100 : (sum of scores) x 25 / (# of questions answered), where 0 represents normality or non-symptomatology and 100 the most severe case. Will be used to measure the symptoms of dry eye disease by obtaining baseline data and comparing them against the last visit. | Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Schirmer Test | Change from Baseline in Schirmer test after 60 days of treatment Schirmer test It is the technique most used to measure aqueous and at the same time the simplest tear secretion. It is carried out as follows: Without applying anesthesia, the patient is placed somewhere without much illumination, without applying anesthesia, a strip of filter paper of approximately 30 mm is placed, of which, 5 mm must go in the joint Of the middle and outer third of the lower eyelid. The patient is instructed to look forward and to blink normally. After 5 minutes the strips are removed and the wetting is recorded in millimeters. A test less than or equal to 6 mm is diagnostic of aqueous deficiency.The mean of the revisions by group will be compared at the baseline and final visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopoldo M Baiza-Durán, MD | Laboratorios Sophia S.A de C.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consultorio privado | Guadalajara | Jalisco | 44600 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27645318 | Derived | Perez-Balbuena AL, Ochoa-Tabares JC, Belalcazar-Rey S, Urzua-Salinas C, Saucedo-Rodriguez LR, Velasco-Ramos R, Suarez-Sanchez RG, Rodriguez-Carrizalez AD, Oregon-Miranda AA. Efficacy of a fixed combination of 0.09 % xanthan gum/0.1 % chondroitin sulfate preservative free vs polyethylene glycol/propylene glycol in subjects with dry eye disease: a multicenter randomized controlled trial. BMC Ophthalmol. 2016 Sep 20;16(1):164. doi: 10.1186/s12886-016-0343-9. |
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The personal data of the study subjects were treated with Confidentiality policy.
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183 patients were enrolled at baseline, however, only 148 ended the period of intervention and 35 were excluded or deleted by different reasons.
Recruitment period started since february 2014 to january 2015. sites of research: Private Medical Office, Ophthalmology Hospitals (nationals and internationals)
Patients with:
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO-148 | PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day PRO-148: Instill 1 drop in each eye four times a day, for 60 days |
| FG001 | Systane® | Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day Systane: Instill 1 drop in each eye four times a day, for 60 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The comparative between baseline and final characteristics, in this section, is considering patients with completely evaluation
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO-148 | PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day PRO-148: Instill 1 drop in each eye four times a day, for 60 days |
| BG001 | Systane® |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Surface Disease Index (OSDI©) Questionnaire | Ocular Surface Disease Index (OSDI©) questionnaire , consists of 12 questions divided in 3 groups, Each question has a value that can go from 0 to 4 points according to the severity of the case: 0.None of the time, 1. Some of the time, 2.Half of the time, 3.most of the time and 4 all of the time. The points of all the questions will be used in the following formula for converted to a score of 0-100 : (sum of scores) x 25 / (# of questions answered), where 0 represents normality or non-symptomatology and 100 the most severe case. Will be used to measure the symptoms of dry eye disease by obtaining baseline data and comparing them against the last visit. | Posted | Mean | Standard Deviation | points | Day 60 | eyes | eyes |
|
The evaluation of serious and no serious adverse events was done during 15 months
in each clinical visit, the ophthalmologist completed the case report and the adverse events format
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRO-148 | PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day PRO-148: Instill 1 drop in each eye four times a day, for 60 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart attack | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | conjunctivitis | Systematic Assessment | During the study 5 patients reported conjunctivitis: 2 patients with allergic conjunctivitis
|
The study was performed according to the clinical protocol.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leopoldo M Baiza-Duran MD, Director of Clinical Trials | Laboratorios Sophia S.A. de C.V. | 52+ 33 30014200 | leopoldo.baiza@sophia.com.mx |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C002563 | xanthan gum |
| D002807 | Chondroitin |
| D019946 | Propylene Glycol |
| C519976 | hydroxypropyl guar |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D011409 | Propylene Glycols |
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| Systane | Drug | Instill 1 drop in each eye four times a day, for 60 days |
|
|
| Day 60 |
| Tear Film Break up Time | Change from Baseline in Tear film break up time after 60 days of treatment Tear film breakup time is the elapsed time from blinking to the first occurrence of a dry area in the cornea, visualized with the help of fluorescein staining. Measurement of tear film breakup time will be performed as follows: Fluorescein is instilled in the eye, the patient is asked to blink three times to distribute the dye and then set the eye to the front and do not blink while the examiner observes the cornea with cobalt blue light, looking for an area of tear film rupture, which is manifested by the appearance of a black island within the fluorescein green film. Normally film breakup time is 10 seconds or more and the minimum register may be 1 second, Under 10 seconds is considered abnormal. | Day 60 |
| Adverse Event |
|
Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar
doses: 1 drop in each eye, quarter in day
Systane: Instill 1 drop in each eye four times a day, for 60 days
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Systane® | Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day Systane: Instill 1 drop in each eye four times a day, for 60 days |
|
|
| Secondary | Schirmer Test | Change from Baseline in Schirmer test after 60 days of treatment Schirmer test It is the technique most used to measure aqueous and at the same time the simplest tear secretion. It is carried out as follows: Without applying anesthesia, the patient is placed somewhere without much illumination, without applying anesthesia, a strip of filter paper of approximately 30 mm is placed, of which, 5 mm must go in the joint Of the middle and outer third of the lower eyelid. The patient is instructed to look forward and to blink normally. After 5 minutes the strips are removed and the wetting is recorded in millimeters. A test less than or equal to 6 mm is diagnostic of aqueous deficiency.The mean of the revisions by group will be compared at the baseline and final visit. | Posted | Mean | Standard Deviation | mm/min | Day 60 | eyes | eyes |
|
|
|
| Secondary | Tear Film Break up Time | Change from Baseline in Tear film break up time after 60 days of treatment Tear film breakup time is the elapsed time from blinking to the first occurrence of a dry area in the cornea, visualized with the help of fluorescein staining. Measurement of tear film breakup time will be performed as follows: Fluorescein is instilled in the eye, the patient is asked to blink three times to distribute the dye and then set the eye to the front and do not blink while the examiner observes the cornea with cobalt blue light, looking for an area of tear film rupture, which is manifested by the appearance of a black island within the fluorescein green film. Normally film breakup time is 10 seconds or more and the minimum register may be 1 second, Under 10 seconds is considered abnormal. | Posted | Mean | Standard Deviation | seconds | Day 60 | eyes | eyes |
|
|
|
| 0 |
| 93 |
| 14 |
| 93 |
| EG001 | Systane® | Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day Systane: Instill 1 drop in each eye four times a day, for 60 days | 1 | 90 | 5 | 90 |
|
| ocular burning sensation | Eye disorders | burning sensation | Systematic Assessment | During the study, 3 patients reported ocular burning sensation |
|
| Pruritus | Eye disorders | Pruritus | Systematic Assessment | In the systematic evaluation, 2 patients reported pruritus |
|
| Red eye | Eye disorders | red eye | Systematic Assessment | In the systematic evaluation, 1 patient presented red eye |
|
| rhinitis | Respiratory, thoracic and mediastinal disorders | rhinitis | Systematic Assessment | During the evaluation, 4 patients had rhinitis. |
|
| Back spasm | Musculoskeletal and connective tissue disorders | back spasm | Systematic Assessment | 1 patient refered back spasm during his participation in the present study |
|
| Dental extraction | Surgical and medical procedures | Dental extraction | Systematic Assessment | 1 patient had infection in one piece dental during his participation in this study |
|
| Lower back pain | Musculoskeletal and connective tissue disorders | lower back pain | Systematic Assessment | 1 patient had lower back pain during its participation in the present study |
|
| Change in the visual acuity | Eye disorders | Visual acuity | Systematic Assessment | 1 patient in the PRO-148 group reported change in the visual acuity. When the clinical ophthalmologist reviewed to the patient, the visual acuity was good. |
|
All the information is confidential and exclusive property of the sponsor. Information can be revealed only to my staff and regulatory agencies or ethics committee.
All the information from this protocol is confidential and exclusive property of the sponsor, it can not be revealed without written consent from the sponsor.
| D006018 |
| Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |