Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye

• Sponsor: Universidad Nacional de Colombia (Other)
• Overall Status: Completed
• CT.gov ID: NCT02257957
• Collaborator: (none)
• Enrollment: 30
• Arms: 2
• Actual Duration (Months): 16.7

Study Details

Study Description

Brief Summary

Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye; Sjogren Syndrome	Drug: PRP injection; Drug: Standard care Hyaluronic acid eye drops	Phase 3

Detailed Description

Dry eye is a chronic condition that decreases function and affect visual function with severe discapacity until now treatments are based in artificial eye drops. Platelet rich plasma has emerged as a strategy for cellular restoration, the purpose of this study is to evaluate their effects in lacrimal production and safety of this intervention in patients with severe dry eye.

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye
• Actual Study Start Date: Nov 30, 2014
• Actual Primary Completion Date: Sep 30, 2015
• Actual Study Completion Date: Apr 20, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Platelet -Rich Plasma (PRP) 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90	Drug: PRP injection
Active Comparator: Standard Care 15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90	Drug: Standard care Hyaluronic acid eye drops; : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Ocular Surface Staining [90 days]

   Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.

2. Change From Baseline in Shirmer Test [90 days]

   The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale

Secondary Outcome Measures

1. Change From Baseline in Ocular Surface Disease Index (OSDI) [90 days]

   The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye. The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• • Patients with symptomatic Dry eye

• Shirmer ≤10 mm in 5 min

• BUT ≤10 seconds

• Corneal staining ≥3

• Age range: 18 years and older.

• Both genders and all ethnic groups comparable with the local community.

• Able to understand and willing to sign a written informed consent

• Able and willing to cooperate with the investigational plan.

• Able and willing to complete all mandatory follow-up visits.

Exclusion Criteria:

• • Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.

• Children under 18.

• Pregnant women or expecting to be pregnant during the study.

• Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.

• Concomitant use of systemic antibiotics or steroids.

• Contact lens wear

• Active ocular infection or allergy

• Unable to close eyes or uncontrolled blinking

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidad Nacional de Colombia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universidad Nacional de Colombia
• ClinicalTrials.gov Identifier: NCT02257957
• Other Study ID Numbers: plasmadry10
• First Posted: Oct 7, 2014
• Last Update Posted: Aug 24, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Sjogren's Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Hyaluronic Acid

Study Results

Participant Flow

Arm/Group Title	Platelet -Rich Plasma (PRP)	Standard Care
Arm/Group Description	15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90 Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
Period Title: Overall Study
STARTED	15	15
COMPLETED	15	15
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Platelet -Rich Plasma (PRP)	Standard Care	Total
Arm/Group Description	15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90 Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90	Total of all reporting groups
Overall Participants	15	15	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.9 (3.5)	52.7 (3.5)	52.7 (3.5)
Sex: Female, Male (Count of Participants)
Female	14 93.3%	14 93.3%	28 93.3%
Male	1 6.7%	1 6.7%	2 6.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Ocular Surface Staining
Description	Surface damage to the exposed eye, assessed by staining, is graded against standard charts. According to the Oxford grade panel (Oxford Scale), the staining was graded and was classified from grade 0 to grade V (0 to 5 score). The minimum value of this scale was 0, which indicating absent surface damage, and the maximum value was 5, which meaning severe surface damages.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet -Rich Plasma (PRP)	Standard Care
Arm/Group Description	15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90 Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	1.2 (0.18)	2.4 (0.18)

2. Primary Outcome

Title	Change From Baseline in Shirmer Test
Description	The Schirmer test I (performed without anaesthesia) was completed before any drops were instilled in the eye. Standardised Schirmer strips (Biotech Vision Care, Gandhinagar, India) were bent at the notch and placed carefully over the lower lid margin as far as possible towards the temporal angle of the lids. The patient was instructed to keep his/her eyelids closed during the test. The strips remained in place for 5 min. After 5 min, the amount of moisture in each strip was measured using a millimetre scale
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet -Rich Plasma (PRP)	Standard Care
Arm/Group Description	15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90 Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
Measure Participants	15	15
Mean (Standard Deviation) [mm]	9.2 (1)	5.3 (0.7)

3. Secondary Outcome

Title	Change From Baseline in Ocular Surface Disease Index (OSDI)
Description	The OSDI consists of 12 questions on items related to the assessment of symptoms, functional limitations and environmental factors related to dry eye. It is graded on a scale of 0-4, with 0 indicating none of the time, 1 for some of the time, 2 for half of the time, 3 for most of the time and 4 indicating all the time. This is a valid and reliable instrument for measuring the severity of dry eye. The total OSDI score was then calculated by the following formula: OSDI = (sum of scores for all questions answered) × 100/(total number of questions answered) × 4). A score of 0-100 was obtained, related to the extent of dry eye, which a higher score representing greater symptoms severity.
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Platelet -Rich Plasma (PRP)	Standard Care
Arm/Group Description	15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90 Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
Measure Participants	15	15
Mean (Standard Deviation) [score on a scale]	34 (4)	55 (2.5)

Adverse Events

Arm/Group Title	Platelet -Rich Plasma (PRP)		Standard Care
Arm/Group Description	15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection		15 patients with diagnosis of severe dry eye will receive standard of care treatment and will be revised at day 0, 30,60,90 Standard care Hyaluronic acid eye drops: : 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
All Cause Mortality
	Platelet -Rich Plasma (PRP)		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Platelet -Rich Plasma (PRP)		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)
Other (Not Including Serious) Adverse Events
	Platelet -Rich Plasma (PRP)		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0%)		0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.