Trial Outcomes & Findings for A Randomized, Controlled, Double-Masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-Host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients (NCT NCT01972438)
NCT ID: NCT01972438
Last Updated: 2016-12-08
Results Overview
A ≥ 50% reduction in the combined score was considered a treatment success. While the design is a crossover study, the primary outcome was assessed after the first period at Month 3. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.
TERMINATED
PHASE2
18 participants
Baseline and 3 months
2016-12-08
Participant Flow
Initially, up to 34 participants were to be enrolled. However, due to the unavailability of the investigational product (IP), recruitment and enrollment was halted at 18 participants in May 2015, and the study closed early. Three participants were enrolled and randomized but unrelated to the early study closure never started IP.
Participant milestones
| Measure |
ASEDs - Saline
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Baseline-Month 3 Crossover Period
STARTED
|
9
|
9
|
|
Baseline-Month 3 Crossover Period
COMPLETED
|
6
|
6
|
|
Baseline-Month 3 Crossover Period
NOT COMPLETED
|
3
|
3
|
|
Months 3-6 Crossover Period
STARTED
|
6
|
7
|
|
Months 3-6 Crossover Period
COMPLETED
|
6
|
6
|
|
Months 3-6 Crossover Period
NOT COMPLETED
|
0
|
1
|
|
Months 6-12 Study Period
STARTED
|
6
|
6
|
|
Months 6-12 Study Period
COMPLETED
|
3
|
4
|
|
Months 6-12 Study Period
NOT COMPLETED
|
3
|
2
|
|
Post Month 12 Study Period
STARTED
|
3
|
4
|
|
Post Month 12 Study Period
COMPLETED
|
0
|
0
|
|
Post Month 12 Study Period
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
ASEDs - Saline
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Baseline-Month 3 Crossover Period
Death
|
1
|
0
|
|
Baseline-Month 3 Crossover Period
Did not meet inclusion criteria
|
1
|
0
|
|
Baseline-Month 3 Crossover Period
Unable to donate blood
|
0
|
1
|
|
Baseline-Month 3 Crossover Period
Scheduling difficulties (Missed Month 3)
|
1
|
2
|
|
Months 3-6 Crossover Period
Early Study Closure
|
0
|
1
|
|
Months 6-12 Study Period
Death
|
1
|
0
|
|
Months 6-12 Study Period
Early Study Closure
|
2
|
2
|
|
Post Month 12 Study Period
Early Study Closure
|
3
|
4
|
Baseline Characteristics
A Randomized, Controlled, Double-Masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-Host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients
Baseline characteristics by cohort
| Measure |
ASEDs - Saline
n=9 Participants
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=9 Participants
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 13.49 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 14.77 • n=7 Participants
|
49.3 years
STANDARD_DEVIATION 14.38 • n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Gender
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: This analysis is conducted on the per-protocol population, defined as those who adhered to the protocol prior to drug unavailability, not on the intent-to-treat population due to lack of visit information beyond baseline for 3 participants. Three never started drug: one was unable to donate blood, one was ineligible at screening and one died.
A ≥ 50% reduction in the combined score was considered a treatment success. While the design is a crossover study, the primary outcome was assessed after the first period at Month 3. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Proportion of Participants Who Experienced a ≥ 50% Reduction in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH/National Eye Institute (NEI) Visual Analogue Scale in the Study Eye From Baseline to Month 3.
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Study Duration, up to 24 monthsOutcome measures
| Measure |
ASEDs - Saline
n=9 Participants
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=9 Participants
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Number of Systemic and Ocular Toxicities and Adverse Events
|
4 adverse events
|
5 adverse events
|
SECONDARY outcome
Timeframe: Study Duration, up to 24 monthsOutcome measures
| Measure |
ASEDs - Saline
n=9 Participants
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=9 Participants
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Number of Participants Withdrawn From the Study Treatment Due to Vision Loss, Adverse Events or Treatment Failure
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 3 Months Compared to Baseline
|
-4.1 scores on a scale
Standard Deviation 1.8
|
-2.6 scores on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 3 Months Compared to Baseline
|
-2.1 scores on a scale
Standard Deviation 2.5
|
-2.5 scores on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Study Eye at 6 Months Compared to Baseline
|
-4.1 scores on a scale
Standard Deviation 3.7
|
-0.5 scores on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
The fellow eye is the untreated eye. Oxford punctate keratopathy is an objective measure from 0-5 (cornea only) and the NIH/NEI visual analogue scale is a subjective grading performed by the participant regarding his/her ocular dryness, redness and irritation (scored 0-3 for each symptom with 0 = none, 1 = mild, 2 = moderate and 3 = severe for a total score between 0-9). The combined score was a number between 0-14 with the higher number representing a worse outcome.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Combined Score of the Modified Oxford Punctate Keratopathy Grading and the NIH Visual Analogue Scale in the Fellow Eye at 6 Months Compared to Baseline
|
-2.4 scores on a scale
Standard Deviation 2.2
|
-2.7 scores on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al\*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome. \*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 3 Months Compared to Baseline
|
-1.2 scores on a scale
Standard Deviation 2.3
|
-1.0 scores on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al\*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome. \*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 3 Months Compared to Baseline
|
1.5 scores on a scale
Standard Deviation 7.1
|
0.8 scores on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al\*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome. \*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Study Eye at 6 Months Compared to Baseline
|
-1.8 scores on a scale
Standard Deviation 3.1
|
-0.4 scores on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
The fellow eye is the untreated eye. The CAS score is the sum of the scores on three separate assessments: Schirmer's tear test without anesthesia, punctate keratopathy and conjunctival inflammation and scarring (scored according to Robinson et. al\*). Each assessment was scored 0-3 with 0 = none, 1 = mild, 2 = moderate and 3 = severe. The higher values represent a worse outcome. The CAS score was a number between 0-9 with the higher number representing a worse outcome. \*Robinson MR, Lee SS, Rubin BI, Wayne AS, Pavletic SZ, Bishop MR, Childs R, Barrett AJ, Csaky KG. Topical Corticosteroid Therapy for Cicatricial Conjunctivitis Associated with Chronic Graft Versus Host Disease. Bone Marrow Transplant. 2004; 18:567-9.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in the Chronic Ocular GVHD Composite Assessment Scale (CAS) Score in the Fellow Eye at 6 Months Compared to Baseline
|
-0.6 scores on a scale
Standard Deviation 1.8
|
-0.2 scores on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 3 Months Compared to Baseline.
|
-2.3 ETDRS letters
Standard Deviation 4.3
|
-7.2 ETDRS letters
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 3 Months Compared to Baseline
|
1.5 ETDRS letters
Standard Deviation 2.4
|
0.3 ETDRS letters
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Study Eye at 6 Months Compared to Baseline
|
1.8 ETDRS letters
Standard Deviation 8.0
|
-4.3 ETDRS letters
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
The fellow eye is the untreated eye. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) in the Fellow Eye at 6 Months Compared to Baseline.
|
0.6 ETDRS letters
Standard Deviation 8.6
|
-2.2 ETDRS letters
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 3 Months Compared to Baseline
|
3.7 seconds
Standard Deviation 6.0
|
1.4 seconds
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 3 Months Compared to Baseline
|
3.3 seconds
Standard Deviation 5.1
|
2.3 seconds
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Stability (Tear Break-up Time) in the Study Eye at 6 Months Compared to Baseline
|
0.2 seconds
Standard Deviation 1.5
|
0.6 seconds
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
The fellow eye is the untreated eye. Sodium fluorescein dye was added to the eye and the tear film was observed under the slit lamp while the participant avoided blinking until tiny dry spots develop. Three measurements were taken and averaged for a more reproducible score.
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Stability (Tear Break-up Time) in the Fellow Eye at 6 Months Compared to Baseline
|
-0.1 seconds
Standard Deviation 2.3
|
-0.1 seconds
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 3 Months Compared to Baseline
|
2.3 mOsm/L
Standard Deviation 20
|
-32.8 mOsm/L
Standard Deviation 24.5
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Composition (Tear Osmolarity) in the Study Eye at 6 Months Compared to Baseline
|
13.5 mOsm/L
Standard Deviation 3.5
|
3.8 mOsm/L
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3.
The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).
Outcome measures
| Measure |
ASEDs - Saline
n=6 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 3 Months Compared to Baseline
|
-0.2 mOsm/L
Standard Deviation 28.5
|
-1.3 mOsm/L
Standard Deviation 12.0
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsPopulation: Twelve participants completed the first crossover treatment period at Month 3. Thirteen participants completed the second crossover treatment period at Month 6.
The fellow eye is the untreated eye. The tear composition test consists of the measurement of tear osmolarity using the Tearlab Osmolarity System (San Diego, California) by collecting a small 50 nanoliter (nL) tear sample which, with the use of laboratory test calculations, can derive the tear osmolarity in milliosmole per liter (mOsm/L).
Outcome measures
| Measure |
ASEDs - Saline
n=7 eyes
Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.
ASEDs - Saline: Experimental Intervention
|
Saline - ASEDs
n=6 eyes
Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.
Saline - ASEDs: Control Intervention
|
|---|---|---|
|
Mean Change in Tear Composition (Tear Osmolarity) in the Fellow Eye at 6 Months Compared to Baseline
|
4.5 mOsm/L
Standard Deviation 0.7
|
6.0 mOsm/L
Standard Deviation 37.6
|
Adverse Events
ASEDs
Saline
ASEDs or Saline
No Intervention
Serious adverse events
| Measure |
ASEDs
n=18 participants at risk
Adverse event occurred when participants were receiving autologous serum eye drops (ASEDs) daily during the crossover period (first six months) of the study.
|
Saline
n=18 participants at risk
Adverse event occurred when participants were receiving control (normal saline) eye drops daily during the crossover period (first six months) of the study.
|
ASEDs or Saline
n=18 participants at risk
Adverse event occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops daily if desired.
|
No Intervention
n=18 participants at risk
Adverse event occurred prior to participants receiving either intervention. Neither ASEDs nor normal saline eye drops were being taken when the event occurred.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
5.6%
1/18 • Number of events 1 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.6%
1/18 • Number of events 1 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
|
Infections and infestations
Aspergillus infection
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
5.6%
1/18 • Number of events 1 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
|
Infections and infestations
Lung Infection
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
5.6%
1/18 • Number of events 1 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
Other adverse events
| Measure |
ASEDs
n=18 participants at risk
Adverse event occurred when participants were receiving autologous serum eye drops (ASEDs) daily during the crossover period (first six months) of the study.
|
Saline
n=18 participants at risk
Adverse event occurred when participants were receiving control (normal saline) eye drops daily during the crossover period (first six months) of the study.
|
ASEDs or Saline
n=18 participants at risk
Adverse event occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops daily if desired.
|
No Intervention
n=18 participants at risk
Adverse event occurred prior to participants receiving either intervention. Neither ASEDs nor normal saline eye drops were being taken when the event occurred.
|
|---|---|---|---|---|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
5.6%
1/18 • Number of events 1 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
|
Eye disorders
Macular oedema
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
5.6%
1/18 • Number of events 1 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
5.6%
1/18 • Number of events 1 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
|
Eye disorders
Cataract subcapsular
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
0.00%
0/18 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
5.6%
1/18 • Number of events 2 • Study Duration, up to 24 months
Of the events:1 occurred while participant was taking autologous serum eye drops (ASEDs);3 occurred when participant(s) were taking normal saline eye drops;3 occurred prior to starting either ASEDs or normal saline eye drops;and 2 occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops
|
Additional Information
Manuel B. Datiles, III, MD, Principal Investigator, NEI
National Institutes of Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place