Trial Outcomes & Findings for Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery (NCT NCT00544713)
NCT ID: NCT00544713
Last Updated: 2011-12-14
Results Overview
Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).
COMPLETED
NA
228 participants
Day 90
2011-12-14
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
114
|
|
Overall Study
COMPLETED
|
111
|
109
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
Total
n=228 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<40 Years
|
88 participants
n=5 Participants
|
92 participants
n=7 Participants
|
180 participants
n=5 Participants
|
|
Age, Customized
>= 40 Years
|
26 participants
n=5 Participants
|
22 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: Intent to Treat population defined as all patients who started the study and were randomized
Measured on 12 domains (categories); a 5-point scale for each domain (0 = best, no dry eye symptoms, 4 = worst, constant dry eye symptoms). Sum of the domain scores is normalized (standardized) to a severity scale of 0-100 (0 = no symptoms (best score), 100 = maximum severity (worst score)).
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
|
8.32 Scores on a Scale
Standard Deviation 11.125
|
6.43 Scores on a Scale
Standard Deviation 8.036
|
SECONDARY outcome
Timeframe: Day 90Population: Intent to Treat includes all patients who started the study are were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).
A questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (referred to as AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree".
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Few min. after use, AT gave clear vision(111/110)
|
94.6 Percentage of Patients
|
94.5 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Liked using these AT (112/110)
|
88.4 Percentage of Patients
|
93.6 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT helped eyes feel comfortable (112/110)
|
94.6 Percentage of Patients
|
94.5 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT were soothing to eyes (111/110)
|
95.5 Percentage of Patients
|
95.4 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT protected eyes from dryness (112/109)
|
88.4 Percentage of Patients
|
89.9 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT protected eyes from low humidity (112/110)
|
78.6 Percentage of Patients
|
82.7 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Vision was normal few min.after AT use(112/110)
|
93.8 Percentage of Patients
|
92.7 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT helped eyes heal from surgery (112/110)
|
83.9 Percentage of Patients
|
86.4 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT helped eyes feel same as pre-LASIK (111/110)
|
85.6 Percentage of Patients
|
89.1 Percentage of Patients
|
|
Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
It's good to use AT after surgery(111/109)
|
97.3 Percentage of Patients
|
96.3 Percentage of Patients
|
SECONDARY outcome
Timeframe: Day 90Population: Intent to Treat includes all patients who started the study and were randomized. Only those patients who answered the particular question on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in the first arm who answered that specific question/Number of patients in the second arm who answered that specific question).
A patient acceptability - sensory questionnaire was administered to all patients to evaluate the acceptability of the Artificial Tears (AT). Percentage of patients responding either "Agree" or "Strongly Agree" at day 90 was tabulated. The potential response categories included "Strongly Agree", "Agree", "Neither Agree Nor Disagree", "Disagree" and "Strongly Disagree".
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Thickness of AT is just right (112/109)
|
79.5 Percentage of Patients
|
87.2 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT did not interfere with vision (112/108)
|
64.3 Percentage of Patients
|
82.4 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT did not cause my eyes to get crusty (112/108)
|
66.1 Percentage of Patients
|
80.6 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT were easy to use (112/109)
|
99.1 Percentage of Patients
|
99.1 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT were convenient to use (112/109)
|
96.4 Percentage of Patients
|
91.7 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT were important to a good outcome (111/109)
|
82.0 Percentage of Patients
|
80.7 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT were helpful to achieve comfort (112/109)
|
92.0 Percentage of Patients
|
93.6 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
AT were helpful to achieve good vision (112/109)
|
71.4 Percentage of Patients
|
76.1 Percentage of Patients
|
|
Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
I no longer feel I need to use AT (111/108)
|
43.2 Percentage of Patients
|
38.0 Percentage of Patients
|
SECONDARY outcome
Timeframe: Day 90Population: Intent to Treat includes all patients who started the study and were randomized. One patient's status in the first arm was not available at Day 90 and was not evaluated for this outcome measure therefore only 113 patients were analyzed for this outcome measure.
BCVA status at Day 90 reported as the number of patients whose scores were either "Better", "No Change", or "Worse" than their scores at baseline. The status was tabulated as number of lines read correctly at Day 90 minus the number of lines read correctly at baseline. "Better" equals increase of 2 lines or more; "No Change" equals change between -2 to +2 lines; "Worse" equals decrease of 2 lines or more. BCVA is measured using a special eye chart a nd is reported as the number of lines (5 letters per line) read correctly.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=113 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Best Corrected Visual Acuity (BCVA) Status at Day 90
Better
|
8 Number of Patients
|
7 Number of Patients
|
|
Best Corrected Visual Acuity (BCVA) Status at Day 90
No Change
|
104 Number of Patients
|
107 Number of Patients
|
|
Best Corrected Visual Acuity (BCVA) Status at Day 90
Worse
|
1 Number of Patients
|
0 Number of Patients
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat population defined as all patients who started the study and were randomized
Change from Baseline in corneal topography of the worse eye as measured using a Pentacam system which calculates a number. Corneal topography is a non-invasive medical imaging technique for mapping the surface of the eye. The Pentacam system measures the pupil and anterior segment (the front part of the eye) which provides a range from 10 (best) to 60 (worst). A negative number change from baseline indicates an improvement.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90
Baseline
|
31.95 Units on a scale
Standard Deviation 11.941
|
32.32 Units on a scale
Standard Deviation 15.347
|
|
Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90
Change from Baseline at Day 90
|
-2.12 Units on a scale
Standard Deviation 6.321
|
-2.24 Units on a scale
Standard Deviation 6.267
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat population defined as all patients who started the study and were randomized
Change from Baseline in corneal topography of the worse eye as measured by a Humphrey Atlas system which calculates a number. Corneal topography is anon-invasive medical imaging technique for mapping the surface curvature of the cornea (the outer structure of the eye). The higher the number the more irregular the cornea. A Humphrey Atlas system detects irregular conditions in the cornea with a range from 0 = best to 2.5 = worst. A negative number change from baseline indicates an improvement.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90
Baseline
|
1.32 Units on a scale
Standard Deviation 0.855
|
1.25 Units on a scale
Standard Deviation 0.456
|
|
Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90
Change from Baseline at Day 90
|
-0.49 Units on a scale
Standard Deviation 0.899
|
-0.26 Units on a scale
Standard Deviation 0.396
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat population defined as all patients who started the study and were randomized
Change from Baseline in total HOA of the worse eye. The total HOA number is measured using a machine that calculates and detects changes in the cornea which could occur post Lasik surgery. A negative number change from baseline indicates an improvement.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90
Baseline
|
0.521 Microns
Standard Deviation 0.1842
|
0.520 Microns
Standard Deviation 0.1845
|
|
Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90
Change from Baseline at Day 90
|
-0.058 Microns
Standard Deviation 0.1509
|
-0.047 Microns
Standard Deviation 0.1452
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat population defined as all patients who started the study and were randomized
Change from baseline in Schirmer's Test results at Day 90 in the worse eye. The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes. The results indicate the presence of dry eye (Normal = greater than or equal to 15 millimeters (mm) of tears, Dry Eye = less than 15 mm of tears). The smaller the number, the more severe the dry eye.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline of the Worse Eye in Schirmer's Test at Day 90
Baseline
|
16.3 Millimeters of Tears
Standard Deviation 8.40
|
13.5 Millimeters of Tears
Standard Deviation 6.30
|
|
Change From Baseline of the Worse Eye in Schirmer's Test at Day 90
Change from Baseline at Day 90
|
-0.3 Millimeters of Tears
Standard Deviation 8.75
|
1.7 Millimeters of Tears
Standard Deviation 9.59
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent to Treat population defined as all patients who started the study and were randomized
Change from Baseline in corneal staining of the worse eye at Day 90. Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), for a minimum score of 0 and a maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement).
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90
Baseline
|
0.5 Scores on a Scale
Standard Deviation 1.13
|
0.5 Scores on a Scale
Standard Deviation 1.12
|
|
Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90
Change from Baseline at Day 90
|
0.0 Scores on a Scale
Standard Deviation 1.12
|
0.0 Scores on a Scale
Standard Deviation 1.47
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat population defined as all patients who started the study and were randomized
Change from Baseline in conjunctival staining of the worse eye using Lissamine Green staining procedure. Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme (0 = no staining and 5 = severe staining), with a minimum score of 0 and a maximum score of 30. The higher the grade score, the worse dry eye condition. A negative number change from baseline represents a decrease in corneal staining (improvement).
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90
Baseline
|
1.0 Scores on a Scale
Standard Deviation 1.98
|
0.8 Scores on a Scale
Standard Deviation 1.32
|
|
Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90
Change from Baseline at Day 90
|
0.0 Scores on a Scale
Standard Deviation 1.65
|
-0.3 Scores on a Scale
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat population defined as all patients who started the study and were randomized
Change from Baseline in TBUT of the worse eye at Day 90. TBUT is the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement).
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90
Baseline
|
13.66 Number of seconds
Standard Deviation 6.133
|
13.25 Number of seconds
Standard Deviation 5.250
|
|
Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90
Change from Baseline at Day 90
|
-0.92 Number of seconds
Standard Deviation 6.013
|
-0.87 Number of seconds
Standard Deviation 12.924
|
SECONDARY outcome
Timeframe: Baseline, Day 90Population: Intent-to-Treat includes all patients that started the study and were randomized. Only those patients who reported actual eye drop use at Baseline and on Day 90 were analyzed. This is indicated in parenthesis as (number of patients in arm 1 who reported eye drop use/number of patients in arm 2 who reported eye drop use).
Change from baseline in the study product usage (average number of uses per day) at Day 90. A negative number change from baseline indicates a reduction in eye drop usage (improvement).
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Change From Baseline in Study Product Usage at Day 90
Baseline (108/108)
|
7.9 Number of study product uses per day
Standard Deviation 3.16
|
7.9 Number of study product uses per day
Standard Deviation 4.89
|
|
Change From Baseline in Study Product Usage at Day 90
Change from Baseline at Day 90 (108/105)
|
-4.9 Number of study product uses per day
Standard Deviation 3.38
|
-4.5 Number of study product uses per day
Standard Deviation 5.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 14, Day 60Population: Intent to Treat includes all patients that started the study and were randomized. Only those patients who were prescribed a dosing regimen at Day 14 to Day 60 visits were analyzed. The is indicated in parenthesis as (number of patients in arm 1 who were prescribed/number of patients in arm 2 who were prescribed).
Number of patients prescribed to each dosing regimen at Day 14 and Day 60. At each visit from Day 14 (the first post-operative visit) to Day 60, patients were prescribed to 1 to 4 dosing regimens based on the investigator's clinical evaluation. Dosing schedule options were: At least every 2 hours while awake, 6 to 8 times per day, 3 to 5 times per day, at 1 to 2 times per day.
Outcome measures
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 Participants
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 Participants
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 14: at least every 2 hrs (113/110)
|
20 Number of patients
|
22 Number of patients
|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 14: 6-8 times a day (113/110)
|
30 Number of patients
|
30 Number of patients
|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 14: 3-5 times a day (113/110)
|
58 Number of patients
|
54 Number of patients
|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 14: 1-2 times a day (113/110)
|
5 Number of patients
|
4 Number of patients
|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 60: at least every 2 hrs (109/107)
|
4 Number of patients
|
3 Number of patients
|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 60: 6-8 times a day (109/107)
|
12 Number of patients
|
14 Number of patients
|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 60: 3-5 times a day (109/107)
|
62 Number of patients
|
60 Number of patients
|
|
Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Day 60: 1-2 times a day (109/107)
|
31 Number of patients
|
30 Number of patients
|
Adverse Events
Carboxymethylcellulose and Glycerin Based Artificial Tear
Carboxymethylcellulose Based Artificial Tear
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carboxymethylcellulose and Glycerin Based Artificial Tear
n=114 participants at risk
Carboxymethylcellulose and Glycerin based artificial tear
|
Carboxymethylcellulose Based Artificial Tear
n=114 participants at risk
Carboxymethylcellulose based artificial tear
|
|---|---|---|
|
Eye disorders
Punctate Keratitis
|
18.4%
21/114
|
19.3%
22/114
|
|
Eye disorders
Halo Vision
|
8.8%
10/114
|
7.9%
9/114
|
|
Eye disorders
Dry Eye
|
8.8%
10/114
|
7.0%
8/114
|
|
Eye disorders
Glare
|
7.0%
8/114
|
6.1%
7/114
|
|
Eye disorders
Conjucntival Haemorrhage
|
7.0%
8/114
|
5.3%
6/114
|
|
Infections and infestations
Nasopharyngitis
|
7.0%
8/114
|
5.3%
6/114
|
|
Injury, poisoning and procedural complications
Eye Operation Complications
|
6.1%
7/114
|
4.4%
5/114
|
|
Eye disorders
Foreign Body Sensation in Eyes
|
5.3%
6/114
|
5.3%
6/114
|
|
Eye disorders
Photophobia
|
4.4%
5/114
|
6.1%
7/114
|
|
Eye disorders
Ocular discomfort
|
4.4%
5/114
|
5.3%
6/114
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER