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

• Sponsor: Laboratorios Sophia S.A de C.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01541891
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: PRO-148 Ophthalmic Solution; Drug: Active Comparator: SYSTANE ® Ophthalmic Solution	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PRO-148 Ophthalmic Solution Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days	Drug: PRO-148 Ophthalmic Solution; PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.; Other Names: PRO-148
Active Comparator: Arm B. SYSTANE® Ophthalmic Solution Drug: SYSTANE® Intervention name: SYSTANE® applied in ocular surface of patients with mild to moderate dry eye syndrome q.i.d. for 60 days	Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Tear Film Break-up Time (TBUT) [During 60 days]

   TBUT was evaluated at baseline and end of the study

Secondary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"	Guadalajara	Jalisco	Mexico	44280

Sponsors and Collaborators

• Laboratorios Sophia S.A de C.V.

Investigators

• Principal Investigator: José F Alaniz-De La O, MD, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
• Principal Investigator: Laura R Saucedo-Rodíguez, MD, Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"
• Study Director: Leopoldo M Baiza-Durán, MD, Clinical Research Department. Laboratorios Sophia SA de CV

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratorios Sophia S.A de C.V.
• ClinicalTrials.gov Identifier: NCT01541891
• Other Study ID Numbers: COXAVSSY0311FII; PRO-148
• First Posted: Mar 1, 2012
• Last Update Posted: Oct 30, 2018
• Last Verified: Feb 1, 2018

• Keywords provided by Laboratorios Sophia S.A de C.V.: PRO-148; Dry eye syndrome
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	30 patients were enrolled in this study at 1 hospital
Pre-assignment Detail	Elegible patients were de novo patients diagnosed with mild to moderate dry eye disease

Arm/Group Title	Arm A PRO 148 Ophthalmic Solution	Arm B. SYSTANE® Ophthalmic Solution
Arm/Group Description	PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	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.
Period Title: Overall Study
STARTED	15	15
COMPLETED	14	14
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Arm A PRO 148 Ophthalmic Solution	Arm B. SYSTANE® Ophthalmic Solution	Total
Arm/Group Description	PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	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 of all reporting groups
Overall Participants	14	14	28
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 100%	14 100%	28 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.8 (8.4)	55.9 (9.6)	55.8 (8.8)
Sex: Female, Male (Count of Participants)
Female	13 92.9%	13 92.9%	26 92.9%
Male	1 7.1%	1 7.1%	2 7.1%
Region of Enrollment (participants) [Number]
Mexico	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Tear Film Break-up Time (TBUT)
Description	TBUT was evaluated at baseline and end of the study
Time Frame	During 60 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A PRO 148 Ophthalmic Solution	Arm B. SYSTANE® Ophthalmic Solution
Arm/Group Description	PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	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.
Measure Participants	14	14
Baseline	5.2 (2.3)	4.7 (2.6)
End of the study	6.1 (2.5)	7.3 (2.5)

2. Secondary Outcome

Title	Presence of Adverse Events
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm A PRO 148 Ophthalmic Solution	Arm B. SYSTANE® Ophthalmic Solution
Arm/Group Description	PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	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.
Measure Participants	14	14
Number [number of cases]	1	0

3. Other Pre-specified Outcome

Title	Evaluation of Visual Acuity
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-148	Arm B. SYSTANE® Ophthalmic Solution
Arm/Group Description	Drug: PRO-148 Intervention name: PRO-148 applied in ocular surface of patients with mild to moderate dry eye syndrome PRO-148 Ophthalmic Solution: PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.	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.
Measure Participants	14	14
Mean (Standard Deviation) [units on LogMAR scale]	0 (0)	0 (0)

Adverse Events

Arm/Group Title	Arm A PRO 148 Ophthalmic Solution		Arm B. SYSTANE® Ophthalmic Solution
Arm/Group Description	PRO-148 Ophthalmic Solution : PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.		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.
All Cause Mortality
	Arm A PRO 148 Ophthalmic Solution		Arm B. SYSTANE® Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm A PRO 148 Ophthalmic Solution		Arm B. SYSTANE® Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Arm A PRO 148 Ophthalmic Solution		Arm B. SYSTANE® Ophthalmic Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/14 (7.1%)		0/14 (0%)
Investigations
Cephalea	1/14 (7.1%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.