Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.

• Sponsor: Laboratorios Sophia S.A de C.V. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01535443
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Days): 30
• Patients Per Site Per Month: 35.5

Study Details

Study Description

Brief Summary

Study to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Cataract	Drug: Bromfenac	Phase 1

Detailed Description

A phase I, open label and unicentric clinical trial to evaluate the safety and tolerability of PRO-155 Ophthalmic Solution 0.09 % in healthy volunteers.

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Fase 1 Study to Evaluate the Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bromfenac Drug: Bromfenac ophthalmic solution 1 drop 4 times per day	Drug: Bromfenac; Drug: Bromfenac Other names: PRO-155; Other Names: PROJECT SOPHIA PRO-155

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [10 days]

   A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst

Secondary Outcome Measures

1. Adverse Events [10 days]

   will be reported the presence of adverse events presented in the study group during the intervention period .

2. Findings in Posterior Segment [10 days]

   Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.

3. Intraocular Pressure (IOP) [10 days]

   Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg.

4. Hyperemia [10 days]

   The red eye will be evaluated by the absence or presence of hyperemia.

5. Burning [10 days]

   Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.

6. Tearing [10 days]

   Tearing will be reported according to the following scale: absent, mild, moderate and severe.

7. Foreign Body Sensation [10 days]

   Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.

8. Photophobia [10 days]

   photophobia will be reported according to the following scale: absent, mild, moderate and severe.

9. Chemosis [10 days]

   chemosis will be reported according to the following scale: absent, mild, moderate and severe.

10. Corneal Damage by Fluorescein Staining Test [10 days]

    Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.

11. Corneal Damage by Lissamine Green Staining Test [10 days]

    Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy male and female.

• Age ≥ 18 years old at screening visit

Exclusion Criteria:

• Any ocular or systemic condition.

• Patient with one blind eye.

• Visual acuity of 20/40 in any eye.

• Use of ocular or systemic medications.

• Contraindications or sensitivity to any component of the study treatments.

• Contact lens users.

• Ocular surgery within the past 3 months..

• Women who were not using an effective means of contraception or who were pregnant or nursing.

• Participation in any studies of investigational drugs within 90 days previous to the inclusion.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Unidad Medica "Grupo Pediátrico"	Guadalajara	Jalisco	Mexico	44690

Sponsors and Collaborators

• Laboratorios Sophia S.A de C.V.

Investigators

• Principal Investigator: Alfredo Lizarraga-Corona, MD, Unidad Medica "Grupo Pediátrico"
• Study Director: Leopoldo M Baiza-Duran, 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: NCT01535443
• Other Study ID Numbers: BRON0611V1FI
• First Posted: Feb 17, 2012
• Last Update Posted: Oct 16, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Laboratorios Sophia S.A de C.V.: PRO-155; Ocular NSAIDs; Safety and tolerability; Ocular Inflammation; Ocular Paint
• Additional relevant MeSH terms: Cataract; Inflammation; Bromfenac

Study Results

Participant Flow

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Period Title: Overall Study
STARTED	35
COMPLETED	32
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..
Overall Participants	35
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	35 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.8 (9.3)
Sex: Female, Male (Count of Participants)
Female	16 45.7%
Male	19 54.3%
Region of Enrollment (participants) [Number]
Mexico	35 100%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	A Snellen chart is an eye chart that can be used to measure visual acuity. consisting of a scale ranging from 20 to 200, where 20 is the best visual capacity and 200 is the worst
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	34
Measure eyes	68
right eye	20.3 (1.2)
left eye	20.2 (0.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PRO-155 Ophthalmic Solution 0.09 %
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.374
	Comments
	Method	Traza Pillai
	Comments	The test was performed with degrees of freedom: 2

2. Secondary Outcome

Title	Adverse Events
Description	will be reported the presence of adverse events presented in the study group during the intervention period .
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Analysis by intention to treat (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..
Measure Participants	35
Measure eyes	70
Number [events]	1

3. Secondary Outcome

Title	Findings in Posterior Segment
Description	Abnormal bores will be reported when assessing the integrity of the posterior segment, the unit of measure will be number of findings.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	34
Measure eyes	68
right eye	1
left eye	1

4. Secondary Outcome

Title	Intraocular Pressure (IOP)
Description	Intraocular pressure (IOP) measurement by applanation tonometry. The unit of measurement will be millimeters of mercury (mmhg) the normal range will be considered 11 to 21 mmhg.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Analyze by intention to treat

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
right aye	13.3 (2.1)
left eye	13.4 (2)

5. Secondary Outcome

Title	Hyperemia
Description	The red eye will be evaluated by the absence or presence of hyperemia.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention to treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
right eye	0
left eye	0

6. Secondary Outcome

Title	Burning
Description	Eye ocular burning will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
Measure eyes	70
right eye : absent	34
right eye : mild	0
right eye : moderate	0
right eye : severe	0
left eye : absent	33
left eye : mild	0
left eye : moderate	0
left eye : severe	1

7. Secondary Outcome

Title	Tearing
Description	Tearing will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
Measure eyes	70
right eye : absent	34
right eye : mild	0
right eye : moderate	0
right eye : severe	0
left eye : absent	34
left eye : mild	0
left eye : moderate	0
left eye : severe	0
left eye : Missing data	1
right eye : Missing data	1

8. Secondary Outcome

Title	Foreign Body Sensation
Description	Foreign body sensation will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
Measure eyes	70
right eye : absent	34
right eye : mild	0
right eye : moderate	0
right eye : severe	0
left eye : absent	34
left eye : mild	0
left eye : moderate	0
left eye : severe	0
left eye: Missing data	1
right eye : Missing data	1

9. Secondary Outcome

Title	Photophobia
Description	photophobia will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
Measure eyes	70
right eye : absent	34
right eye : mild	0
right eye : moderate	0
right eye : severe	0
left eye : absent	34
left eye : mild	0
left eye : moderate	0
left eye : severe	0
left eye : Missing data	1
right eye : Missing data	1

10. Secondary Outcome

Title	Chemosis
Description	chemosis will be reported according to the following scale: absent, mild, moderate and severe.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
Measure eyes	70
right eye : absent	34
right eye : mild	0
right eye : moderate	0
right eye : severe	0
left eye : absent	34
left eye : mild	0
left eye : moderate	0
left eye : severe	0
left eye : Missing data	1
right eye : Missing data	1

11. Secondary Outcome

Title	Corneal Damage by Fluorescein Staining Test
Description	Corneal damage will be reported by Fluorescein eye staining using the following scale: absent, mild, moderate, and severe.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
Measure eyes	70
right eye : absent	34
right eye : mild	0
right eye : moderate	0
right eye : severe	0
left eye : absent	34
left eye : mild	0
left eye : moderate	0
left eye : severe	0
left eye : Missing data	1
right eye : Missing data	1

12. Secondary Outcome

Title	Corneal Damage by Lissamine Green Staining Test
Description	Corneal damage will be reported by lissamine green staining using the following scale: absent, mild, moderate, and severe.
Time Frame	10 days

Outcome Measure Data

Analysis Population Description

Intention-to-treat analysis (ITT)

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice a day during 10 days..
Measure Participants	35
Measure eyes	70
right eye : absent	34
right eye : mild	0
right eye : moderate	0
right eye : severe	0
left eye : absent	34
left eye : mild	0
left eye : moderate	0
left eye : severe	0
left eye : Missing data	1
right eye : Missing data	1

Adverse Events

Arm/Group Title	PRO-155 Ophthalmic Solution 0.09 %
Arm/Group Description	PRO-155 Ophthalmic Solution 0.09 % : PRO-155 Ophthalmic Solution 0.09 % applied twice to day during 10 days..
All Cause Mortality
	PRO-155 Ophthalmic Solution 0.09 %
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	PRO-155 Ophthalmic Solution 0.09 %
	Affected / at Risk (%)	# Events
Total	0/35 (0%)
Other (Not Including Serious) Adverse Events
	PRO-155 Ophthalmic Solution 0.09 %
	Affected / at Risk (%)	# Events
Total	0/35 (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.