Dry Eye Syndrome
Conditions
Keywords
PRO-148, Dry eye syndrome
Brief summary
The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
Detailed description
A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.
Interventions
DRUGPRO-148 Ophthalmic Solution
PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
DRUGActive Comparator: SYSTANE ® Ophthalmic Solution
Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 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
* Patients with diagnosis of mild-to-moderate drye eye syndrome. * Male or female patients. * Patients 18 years of age
Exclusion criteria
* Patients with one blind eye. * Visual acuity of 20/40 in any eye * Patients with history of active stage of any other concomitant ocular disease. * Patients taking any medication, topically or by any other route, which could interfere with the study's results, in the 3 days prior to trial or until a time period in which residual effects could be present. * Contraindications or sensitivity to any component of the study treatments. * Ocular surgery within the past 3 months. * Contact lens users. * Females of childbearing potential )may not participate in the study if any of the following conditions exist: * They are pregnant, * They are breastfeeding, * They have a positive urine pregnancy test at screening, * They intend to become pregnant during the study, or * They do not agree to use adequate birth control methods for the duration of the study. * Participation in any studies of investigational drugs within 90 days previous to the inclusion. Discontinuation criteria: * Patients could be discontinued before the completion of the study because of adverse events, pregnancy, protocol violations, lack of efficacy, or administrative reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Film Break-up Time (TBUT) | During 60 days | TBUT was evaluated at baseline and end of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Adverse Events | 60 days | The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Visual Acuity | 60 days | The LogMAR scale evaluates the visual acuity of subjects with a logarithmic scale where base 0 is the best visual acuity and 1 is the worst. This variable will be reported with means for comparison between groups. |
Countries
Mexico
Participant flow
Recruitment details
30 patients were enrolled in this study at 1 hospital
Pre-assignment details
Elegible patients were de novo patients diagnosed with mild to moderate dry eye disease
Participants by arm
| Arm | Count |
|---|---|
| Arm A PRO 148 Ophthalmic Solution PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days. | 14 |
| Arm B. SYSTANE® Ophthalmic Solution Active Comparator: SYSTANE ® Ophthalmic Solution : Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Arm B. SYSTANE® Ophthalmic Solution | Arm A PRO 148 Ophthalmic Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Continuous | 55.9 years STANDARD_DEVIATION 9.6 | 55.8 years STANDARD_DEVIATION 8.4 | 55.8 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment Mexico | 14 participants | 14 participants | 28 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 26 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Tear Film Break-up Time (TBUT)
TBUT was evaluated at baseline and end of the study
Time frame: During 60 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm A PRO 148 Ophthalmic Solution | Tear Film Break-up Time (TBUT) | Baseline | 5.2 seconds | Standard Deviation 2.3 |
| Arm A PRO 148 Ophthalmic Solution | Tear Film Break-up Time (TBUT) | End of the study | 6.1 seconds | Standard Deviation 2.5 |
| Arm B. SYSTANE® Ophthalmic Solution | Tear Film Break-up Time (TBUT) | Baseline | 4.7 seconds | Standard Deviation 2.6 |
| Arm B. SYSTANE® Ophthalmic Solution | Tear Film Break-up Time (TBUT) | End of the study | 7.3 seconds | Standard Deviation 2.5 |
Secondary
Presence of Adverse Events
The presence of adverse events will be reported in both treatment arms. This variable will be reported by the number of events presented.
Time frame: 60 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm A PRO 148 Ophthalmic Solution | Presence of Adverse Events | 1 number of cases |
| Arm B. SYSTANE® Ophthalmic Solution | Presence of Adverse Events | 0 number of cases |
Other Pre-specified
Evaluation of Visual Acuity
The LogMAR scale evaluates the visual acuity of subjects with a logarithmic scale where base 0 is the best visual acuity and 1 is the worst. This variable will be reported with means for comparison between groups.
Time frame: 60 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm A PRO 148 Ophthalmic Solution | Evaluation of Visual Acuity | 0 units on LogMAR scale | Standard Deviation 0 |
| Arm B. SYSTANE® Ophthalmic Solution | Evaluation of Visual Acuity | 0 units on LogMAR scale | Standard Deviation 0 |