Trial Outcomes & Findings for Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye (NCT NCT02257957)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

90 days

Results posted on

2021-08-24

Participant Flow

Participant milestones

Participant milestones
Measure	Platelet -Rich Plasma (PRP) 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	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 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
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platelet -Rich Plasma (PRP) n=15 Participants 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	Standard Care n=15 Participants 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 n=30 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 3.5 • n=93 Participants	52.7 years STANDARD_DEVIATION 3.5 • n=4 Participants	52.7 years STANDARD_DEVIATION 3.5 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	14 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Platelet -Rich Plasma (PRP) n=15 Participants 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	Standard Care n=15 Participants 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
Change From Baseline in Ocular Surface Staining	1.2 score on a scale Standard Deviation 0.18	2.4 score on a scale Standard Deviation 0.18

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Platelet -Rich Plasma (PRP) n=15 Participants 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	Standard Care n=15 Participants 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
Change From Baseline in Shirmer Test	9.2 mm Standard Deviation 1	5.3 mm Standard Deviation 0.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Platelet -Rich Plasma (PRP) n=15 Participants 15 patients with diagnosis of severe dry eye will receive PRP injection at day 0, 30,60 and 90 PRP injection	Standard Care n=15 Participants 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
Change From Baseline in Ocular Surface Disease Index (OSDI)	34 score on a scale Standard Deviation 4	55 score on a scale Standard Deviation 2.5

Adverse Events

Platelet -Rich Plasma (PRP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Marcel Y Avila

Universidad Nacional de Colombia

Phone: +5713165000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place