Trial Outcomes & Findings for Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears (NCT NCT01614847)
NCT ID: NCT01614847
Last Updated: 2020-04-03
Results Overview
Raw data: Baseline (pre-instillation) tear osmolarity was measured for right and left eyes for each subject. Then measurements were repeated at 7 times (5, 20, 35, 50, 65 890 and 95 minutes) after instillation. Data processing: 1) Baseline osmolarity was subtracted from each post-baseline measurement to give a change-from-baseline values. 2) Right and left eye change values averaged to give a mean osmolarity change for each subject at each of the seven times. 3) Mean osmolarity changes values were averaged across 8 subjects for each of the 7 times and entered in the table below. Row 1 is for Drop A (hyaluronate); Row 2 for Drop B (saline). Column are for the 7 times.
COMPLETED
PHASE4
8 participants
Baseline, followed by 7 measurements made after instillation (5, 20, 35, 50, 65, 80, 95 minutes post-instillation).
2020-04-03
Participant Flow
A convenience sample of 8 subjects was recuitted from among the student population at the NSU Oklahoma College of Optometry during May-June 2012.
Subjects were assigned random ID numbers in preparation for assignment into the two groups. Half (4 subjects) chosen at random, would be assigned to Group 1, and receive Drop A on Day 1, then return 24 hours (Day 2) later to received Drop B. The other 4 subjects would be assigned to Group 1, and receive Drop B on Day 1 and Drop A on Day 2.
Participant milestones
| Measure |
Group 1: Four Subjects Who Received Drop A on Day 1
All eight subject received Drop A (hyaluronate) on one day and Drop B (saline) on the other day. Subjects #1, 2, 3, 4 received Drop A on Day 1 and Drop B on Day 2.
|
Group 2: Four Subjects Who Received Drop B on Day 1
All eight subject received Drop A (hyaluronate) on one day and Drop B (saline) on the other day. Subjects #5, 6, 7, 8 received Drop B on Day 1 and Drop A on Day 2.
|
|---|---|---|
|
Day 1
STARTED
|
4
|
4
|
|
Day 1
COMPLETED
|
4
|
4
|
|
Day 1
NOT COMPLETED
|
0
|
0
|
|
Day 2 (24 Hours Later)
STARTED
|
4
|
4
|
|
Day 2 (24 Hours Later)
COMPLETED
|
4
|
4
|
|
Day 2 (24 Hours Later)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tear Osmolarity Changes After Instilling Isotonic Hyaluronate Artificial Tears
Baseline characteristics by cohort
| Measure |
Arm 1. Isotonic Hyaluronate Artificial Tear FIRST
n=4 Participants
Per sequence. Four subject, chosen at random, will receive isotonic hyaluronate artificial tear in Session 1. After a 24-hour washout period, they will return for Session 2, when they will receive saline eye drops.
|
Arm 2. Normal Saline FIRST
n=4 Participants
Per sequence. The four remaining subject (see comments to left), will receive saline eye drops in Session 1. After a 24-hour washout period, they will return for Session 2, when they will receive isotonic hyaluronate artificial tears.
|
Total
n=8 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.8 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
28.0 years
STANDARD_DEVIATION 4.8 • n=7 Participants
|
26.9 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, followed by 7 measurements made after instillation (5, 20, 35, 50, 65, 80, 95 minutes post-instillation).Population: Eight subjects recruited from among students at the NSU Oklahoma College of Optometry, including 6 males and 2 females who were at least 18 years of age and who had no known ocular or systemic disease other than dry eye. Six subjects did not have dry eye and 2 were diagnosed with dry eye based on Ocular Surface Disease Index (OSDI) survey scores.
Raw data: Baseline (pre-instillation) tear osmolarity was measured for right and left eyes for each subject. Then measurements were repeated at 7 times (5, 20, 35, 50, 65 890 and 95 minutes) after instillation. Data processing: 1) Baseline osmolarity was subtracted from each post-baseline measurement to give a change-from-baseline values. 2) Right and left eye change values averaged to give a mean osmolarity change for each subject at each of the seven times. 3) Mean osmolarity changes values were averaged across 8 subjects for each of the 7 times and entered in the table below. Row 1 is for Drop A (hyaluronate); Row 2 for Drop B (saline). Column are for the 7 times.
Outcome measures
| Measure |
5 Minutes
n=8 Participants
Mean\* change in tear osmolarity (mOsmol/L) from baseline 5 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (\*Mean of change values measured for right and left eyes.)
|
20 Minutes
n=16 Eyes
Mean\* change in tear osmolarity (mOsmol/L) from baseline 20 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (\*Mean of change values measured for right and left eyes.)
|
35 Minutes
n=16 Eyes
Mean\* change in tear osmolarity (mOsmol/L) from baseline 35 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (\*Mean of change values measured for right and left eyes.)
|
50 Minutes
n=16 Eyes
Mean\* change in tear osmolarity (mOsmol/L) from baseline 50 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (\*Mean of change values measured for right and left eyes.)
|
65 Minutes
n=16 Eyes
Mean\* change in tear osmolarity (mOsmol/L) from baseline 65 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (\*Mean of change values measured for right and left eyes.)
|
80 Minutes
n=16 Eyes
Mean\* change in tear osmolarity (mOsmol/L) from baseline 80 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (\*Mean of change values measured for right and left eyes.)
|
95 Minutes
n=16 Eyes
Mean\* change in tear osmolarity (mOsmol/L) from baseline 95 minutes after instillation of Drop A (Blink Contacts; hyaluronate) for each subject. (\*Mean of change values measured for right and left eyes.)
|
|---|---|---|---|---|---|---|---|
|
Osmolarity Change From Baseline (mOsms/L) as a Function of Time (Minutes)
Drop A
|
-0.94 mOsmols/L
Standard Error 0.62
|
7.25 mOsmols/L
Standard Error 1.49
|
5.31 mOsmols/L
Standard Error 2.19
|
-4.25 mOsmols/L
Standard Error 1.26
|
7.5 mOsmols/L
Standard Error 1.61
|
2.31 mOsmols/L
Standard Error 1.54
|
9.25 mOsmols/L
Standard Error 1.39
|
|
Osmolarity Change From Baseline (mOsms/L) as a Function of Time (Minutes)
Drop B
|
-0.8 mOsmols/L
Standard Error 0.97
|
-2.1 mOsmols/L
Standard Error 1.43
|
2.5 mOsmols/L
Standard Error 2.09
|
4.4 mOsmols/L
Standard Error 1.35
|
4.9 mOsmols/L
Standard Error 1.31
|
1.9 mOsmols/L
Standard Error 1.32
|
8.6 mOsmols/L
Standard Error 1.9
|
Adverse Events
Isotonic Hyaluronate Artificial Tear
Normal Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Thomas O. Salmon, OD, PhD, Professor
Northeastern State University Oklahoma College of Optometry
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place