Trial Outcomes & Findings for Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye (NCT NCT01657253)

Last Updated: 2017-12-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

183 participants

Primary outcome timeframe

Day 60

Results posted on

2017-12-15

Participant Flow

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

183 patients were enrolled at baseline, however, only 148 ended the period of intervention and 35 were excluded or deleted by different reasons.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	93	90
Overall Study COMPLETED	76	72
Overall Study NOT COMPLETED	17	18

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Lost to Follow-up	6	5
Overall Study Withdrawal by Subject	11	12
Overall Study Adverse Event	0	1

Baseline Characteristics

Efficacy and Safety of PRO-148 Versus Systane®, in Patients With Mild to Moderate Dry Eye

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PRO-148 n=93 Participants 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	Systane® n=90 Participants 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	Total n=183 Participants Total of all reporting groups
Age, Continuous	48.3 years STANDARD_DEVIATION 16.0 • n=5 Participants	45.3 years STANDARD_DEVIATION 13.8 • n=7 Participants	46.8 years STANDARD_DEVIATION 14.9 • n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	65 Participants n=7 Participants	132 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	25 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	93 Participants n=5 Participants	90 Participants n=7 Participants	183 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Mexico	59 participants n=5 Participants	63 participants n=7 Participants	122 participants n=5 Participants
Region of Enrollment Chile	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants
Region of Enrollment Colombia	17 participants n=5 Participants	12 participants n=7 Participants	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 60

Outcome measures

Outcome measures
Measure	PRO-148 n=152 eyes 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	Systane® n=144 eyes 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
Ocular Surface Disease Index (OSDI©) Questionnaire baseline values	19.3 points Standard Deviation 7.4	19.3 points Standard Deviation 7.5
Ocular Surface Disease Index (OSDI©) Questionnaire final values	7.3 points Standard Deviation 5.9	7.9 points Standard Deviation 8.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PRO-148 n=152 eyes 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	Systane® n=144 eyes 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
Schirmer Test baseline values	6.4 mm/min Standard Deviation 2.2	6.5 mm/min Standard Deviation 2.5
Schirmer Test final values	11.0 mm/min Standard Deviation 6.6	10.5 mm/min Standard Deviation 5.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PRO-148 n=152 eyes 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	Systane® n=144 eyes 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
Tear Film Break up Time baseline values	5.5 seconds Standard Deviation 2.1	5.2 seconds Standard Deviation 2.0
Tear Film Break up Time final values	7.4 seconds Standard Deviation 2.9	7.4 seconds Standard Deviation 2.7

Adverse Events

PRO-148

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Systane®

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PRO-148 n=93 participants at risk 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	Systane® n=90 participants at risk 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
Cardiac disorders heart attack	0.00% 0/93 • 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	1.1% 1/90 • Number of events 1 • 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

Other adverse events

Other adverse events
Measure	PRO-148 n=93 participants at risk 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	Systane® n=90 participants at risk 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
Eye disorders Conjunctivitis	5.4% 5/93 • Number of events 5 • 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	0.00% 0/90 • 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
Eye disorders ocular burning sensation	3.2% 3/93 • Number of events 3 • 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	0.00% 0/90 • 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
Eye disorders Pruritus	2.2% 2/93 • Number of events 2 • 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	0.00% 0/90 • 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
Eye disorders Red eye	1.1% 1/93 • Number of events 1 • 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	0.00% 0/90 • 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
Respiratory, thoracic and mediastinal disorders rhinitis	1.1% 1/93 • Number of events 1 • 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	3.3% 3/90 • Number of events 3 • 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
Musculoskeletal and connective tissue disorders Back spasm	0.00% 0/93 • 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	1.1% 1/90 • Number of events 1 • 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
Surgical and medical procedures Dental extraction	1.1% 1/93 • Number of events 1 • 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	0.00% 0/90 • 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
Musculoskeletal and connective tissue disorders Lower back pain	1.1% 1/93 • Number of events 1 • 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	0.00% 0/90 • 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
Eye disorders Change in the visual acuity	0.00% 0/93 • 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	1.1% 1/90 • Number of events 1 • 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

Additional Information

Leopoldo M Baiza-Duran MD, Director of Clinical Trials

Laboratorios Sophia S.A. de C.V.

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