Trial Outcomes & Findings for Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome (NCT NCT01541891)

Results Overview

TBUT was evaluated at baseline and end of the study

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

During 60 days

Results posted on

2018-10-30

Participant Flow

30 patients were enrolled in this study at 1 hospital

Elegible patients were de novo patients diagnosed with mild to moderate dry eye disease

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15	15
Overall Study COMPLETED	14	14
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A PRO 148 Ophthalmic Solution n=14 Participants PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	Arm B. SYSTANE® Ophthalmic Solution n=14 Participants 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.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	55.8 years STANDARD_DEVIATION 8.4 • n=5 Participants	55.9 years STANDARD_DEVIATION 9.6 • n=7 Participants	55.8 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment Mexico	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: During 60 days

TBUT was evaluated at baseline and end of the study

Outcome measures

Outcome measures
Measure	Arm A PRO 148 Ophthalmic Solution n=14 Participants PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	Arm B. SYSTANE® Ophthalmic Solution n=14 Participants 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.
Tear Film Break-up Time (TBUT) Baseline	5.2 seconds Standard Deviation 2.3	4.7 seconds Standard Deviation 2.6
Tear Film Break-up Time (TBUT) End of the study	6.1 seconds Standard Deviation 2.5	7.3 seconds Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A PRO 148 Ophthalmic Solution n=14 Participants PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	Arm B. SYSTANE® Ophthalmic Solution n=14 Participants 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.
Presence of Adverse Events	1 number of cases	0 number of cases

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Arm A PRO 148 Ophthalmic Solution n=14 Participants PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	Arm B. SYSTANE® Ophthalmic Solution n=14 Participants 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.
Evaluation of Visual Acuity	0 units on LogMAR scale Standard Deviation 0	0 units on LogMAR scale Standard Deviation 0

Adverse Events

Arm A PRO 148 Ophthalmic Solution

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm B. SYSTANE® Ophthalmic Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm A PRO 148 Ophthalmic Solution n=14 participants at risk PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	Arm B. SYSTANE® Ophthalmic Solution n=14 participants at risk 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.
Investigations Cephalea	7.1% 1/14	0.00% 0/14

Additional Information

Baiza-Duran Leopoldo, Medical Director

Laboratorios Sophia, SA de CV

Phone: +52 (33)30014200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER