A Phase 3 interventional study of PRO-148 and Systane in Dry Eye, sponsored by Laboratorios Sophia S.A de C.V.. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-15.
Sponsored by Laboratorios Sophia S.A de C.V. · Phase 3, Interventional, and Treatment
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
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's enrollment of 183 is above the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Laboratorios Sophia S.A de C.V. is the lead sponsor of 45 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
PRO-148 containing: xanthan gum and sulphate chondroitin, ophthalmic solution doses: 1 drop in each eye, quarter in day
Drug: PRO-148
Systane containing: polyethylene glycol 400 0.4%, propylene glycol 0.3% and hydroxypropyl guar doses: 1 drop in each eye, quarter in day
Drug: Systane
Instill 1 drop in each eye four times a day, for 60 days
Also known as: PRO-148 (xanthan gum and sulphate chondroitin)
Drug pages: Polyethylene glycol 400 · Propylene Glycol
Instill 1 drop in each eye four times a day, for 60 days
Also known as: polyethyleneglycol 400, propyleneglycol, hydroxypropyl guar
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.
Time frame: Day 60
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.
Time frame: 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.
Time frame: Day 60
Recruitment period started since february 2014 to january 2015. sites of research: Private Medical Office, Ophthalmology Hospitals (nationals and internationals) Patients with: * mild to moderate Dry eye * age \> 18 year old * OSDI between 12 and 45 * TBUT ≤ 10 seconds * Schirmer test ≤ 10mm
| Milestone | PRO-148 | Systane® |
|---|---|---|
| Started | 93 | 90 |
| Completed | 76 | 72 |
| Not completed | 17 | 18 |
| Withdrew: Lost to follow-up | 6 | 5 |
| Withdrew: Withdrawal by subject | 11 | 12 |
| Withdrew: Adverse event | 0 | 1 |
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.
| points | PRO-148 | Systane® |
|---|---|---|
| baseline values | 19.3 ± 7.4 | 19.3 ± 7.5 |
| final values | 7.3 ± 5.9 | 7.9 ± 8.2 |
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.
| mm/min | PRO-148 | Systane® |
|---|---|---|
| baseline values | 6.4 ± 2.2 | 6.5 ± 2.5 |
| final values | 11.0 ± 6.6 | 10.5 ± 5.6 |
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.
| seconds | PRO-148 | Systane® |
|---|---|---|
| baseline values | 5.5 ± 2.1 | 5.2 ± 2.0 |
| final values | 7.4 ± 2.9 | 7.4 ± 2.7 |
Collected over The evaluation of serious and no serious adverse events was done during 15 months. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PRO-148 | — | 0/93 (0%) | 14/93 (15.1%) |
| Systane® | — | 1/90 (1.1%) | 5/90 (5.6%) |
| Event | PRO-148 | Systane® |
|---|---|---|
| heart attackCardiac disorders | 0/93 | 1/90 |
| Event | PRO-148 | Systane® |
|---|---|---|
| ConjunctivitisEye disorders | 5/93 | 0/90 |
| rhinitisRespiratory, thoracic and mediastinal disorders | 1/93 | 3/90 |
| ocular burning sensationEye disorders | 3/93 | 0/90 |
| PruritusEye disorders | 2/93 | 0/90 |
| Back spasmMusculoskeletal and connective tissue disorders | 0/93 | 1/90 |
| Change in the visual acuityEye disorders | 0/93 | 1/90 |
| Red eyeEye disorders | 1/93 | 0/90 |
| Dental extractionSurgical and medical procedures | 1/93 | 0/90 |
| Lower back painMusculoskeletal and connective tissue disorders | 1/93 | 0/90 |
The comparative between baseline and final characteristics, in this section, is considering patients with completely evaluation
| Age, Continuous(years) | PRO-148 | Systane® | Total |
|---|---|---|---|
| Mean | 48.3 ± 16.0 | 45.3 ± 13.8 | 46.8 ± 14.9 |
| Sex: Female, Male(Participants) | PRO-148 | Systane® | Total |
|---|---|---|---|
| Female | 67 | 65 | 132 |
| Male | 26 | 25 | 51 |
| Ethnicity (NIH/OMB)(Participants) | PRO-148 | Systane® | Total |
|---|---|---|---|
| Hispanic or Latino | 93 | 90 | 183 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | PRO-148 | Systane® | Total |
|---|---|---|---|
| Mexico | 59 | 63 | 122 |
| Chile | 17 | 15 | 32 |
| Colombia | 17 | 12 | 29 |
Plan to share: No — The personal data of the study subjects were treated with Confidentiality policy.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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