Dry Eye
Conditions
Brief summary
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®
Detailed description
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
Interventions
DRUGPRO-148
Instill 1 drop in each eye four times a day, for 60 days
DRUGSystane
Instill 1 drop in each eye four times a day, for 60 days
Sponsors
Laboratorios Sophia S.A de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild to moderate dry eye patients based on the Report of International Dry Eye Workshop (DEWS) * OSDI score between 12 and 45 * Provided informed consent
Exclusion criteria
* Patients with one blind eye * Visual acuity of 20/100 or worst in any eye * Patients with any active ocular disease that would interfere with study interpretation * Patients in treatment with any medication that could interfere with the study, contraindication of any medication used in the protocol * Patients with history of hypersensitivity or contraindication for any drug used in the study * Contact lens users * Pregnant patients, at risk of pregnancy or breastfeeding * Patients without birth control treatment * Patients who had participated in any clinical trial in the last 90 days * Legal or mentally disabled patients who could not give informed consent * Patients who do not provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Surface Disease Index (OSDI©) Questionnaire | Day 60 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer Test | Day 60 | 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. |
| Tear Film Break up Time | Day 60 | 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. |
Countries
Mexico
Participant flow
Recruitment details
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
Pre-assignment details
183 patients were enrolled at baseline, however, only 148 ended the period of intervention and 35 were excluded or deleted by different reasons.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 93 |
| 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 | 90 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | Withdrawal by Subject | 11 | 12 |
Baseline characteristics
| Characteristic | Systane® | Total | PRO-148 |
|---|---|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 13.8 | 46.8 years STANDARD_DEVIATION 14.9 | 48.3 years STANDARD_DEVIATION 16 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 90 Participants | 183 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Chile | 15 participants | 32 participants | 17 participants |
| Region of Enrollment Colombia | 12 participants | 29 participants | 17 participants |
| Region of Enrollment Mexico | 63 participants | 122 participants | 59 participants |
| Sex: Female, Male Female | 65 Participants | 132 Participants | 67 Participants |
| Sex: Female, Male Male | 25 Participants | 51 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 93 | 5 / 90 |
| serious Total, serious adverse events | 0 / 93 | 1 / 90 |
Outcome results
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.
Time frame: Day 60
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-148 | Ocular Surface Disease Index (OSDI©) Questionnaire | baseline values | 19.3 points | Standard Deviation 7.4 |
| PRO-148 | Ocular Surface Disease Index (OSDI©) Questionnaire | final values | 7.3 points | Standard Deviation 5.9 |
| Systane® | Ocular Surface Disease Index (OSDI©) Questionnaire | baseline values | 19.3 points | Standard Deviation 7.5 |
| Systane® | Ocular Surface Disease Index (OSDI©) Questionnaire | final values | 7.9 points | Standard Deviation 8.2 |
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.
Time frame: Day 60
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-148 | Schirmer Test | baseline values | 6.4 mm/min | Standard Deviation 2.2 |
| PRO-148 | Schirmer Test | final values | 11.0 mm/min | Standard Deviation 6.6 |
| Systane® | Schirmer Test | baseline values | 6.5 mm/min | Standard Deviation 2.5 |
| Systane® | Schirmer Test | final values | 10.5 mm/min | Standard Deviation 5.6 |
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.
Time frame: Day 60
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO-148 | Tear Film Break up Time | baseline values | 5.5 seconds | Standard Deviation 2.1 |
| PRO-148 | Tear Film Break up Time | final values | 7.4 seconds | Standard Deviation 2.9 |
| Systane® | Tear Film Break up Time | baseline values | 5.2 seconds | Standard Deviation 2 |
| Systane® | Tear Film Break up Time | final values | 7.4 seconds | Standard Deviation 2.7 |