Evaluate the Safety and Efficacy of a New Artificial Tear for Use After LASIK Surgery

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00544713
• Collaborator: (none)
• Enrollment: 228
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 25.3

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of a new artificial tear for the treatment of dry eye that may occur after LASIK surgery

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: Carboxymethylcellulose and Glycerin based artificial tear; Drug: Carboxymethylcellulose	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 228 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carboxymethylcellulose and Glycerin based artificial tear Carboxymethylcellulose and Glycerin based artificial tear	Drug: Carboxymethylcellulose and Glycerin based artificial tear; As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake
Active Comparator: Carboxymethylcellulose based artificial tear Carboxymethylcellulose based artificial tear	Drug: Carboxymethylcellulose; As directed by Investigator at the end of each study visit: 1 to 2 drops in each eye, 1 to 2 times a day up to every hour while awake; Other Names: Refresh Plus®

Outcome Measures

Primary Outcome Measures

1. Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90 [Day 90]

   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)).

Secondary Outcome Measures

1. Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 [Day 90]

   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".

2. Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90 [Day 90]

   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".

3. Best Corrected Visual Acuity (BCVA) Status at Day 90 [Day 90]

   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.

4. Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90 [Baseline, Day 90]

   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.

5. Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90 [Baseline, Day 90]

   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.

6. Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90 [Baseline, Day 90]

   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.

7. Change From Baseline of the Worse Eye in Schirmer's Test at Day 90 [Baseline, Day 90]

   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.

8. Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90 [Baseline, Day 90]

   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).

9. Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90 [Baseline, Day 90]

   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).

10. Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90 [Baseline, Day 90]

    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).

11. Change From Baseline in Study Product Usage at Day 90 [Baseline, Day 90]

    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).

Other Outcome Measures

1. Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60 [Day 14, Day 60]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Candidate for bilateral LASIK surgery for myopia correction in the range of -1.00 to -8.00 diopters

Exclusion Criteria:

• Dry eye signs and symptoms

• Preoperative soft or rigid contact lens wear within last 7 or 30 days, respectively

• Pregnancy or planning pregnancy

• Uncontrolled systemic disease

• Use of systemic medications affecting dry eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Diego	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00544713
• Other Study ID Numbers: AG9818-001
• First Posted: Oct 16, 2007
• Last Update Posted: Dec 14, 2011
• Last Verified: Nov 1, 2011

• Additional relevant MeSH terms: Dry Eye Syndromes; Carboxymethylcellulose Sodium; Lubricant Eye Drops; Glycerol

Study Results

Participant Flow

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Period Title: Overall Study
STARTED	114	114
COMPLETED	111	109
NOT COMPLETED	3	5

Baseline Characteristics

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear	Total
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear	Total of all reporting groups
Overall Participants	114	114	228
Age, Customized (participants) [Number]
<40 Years	88 77.2%	92 80.7%	180 78.9%
>= 40 Years	26 22.8%	22 19.3%	48 21.1%
Sex: Female, Male (Count of Participants)
Female	62 54.4%	51 44.7%	113 49.6%
Male	52 45.6%	63 55.3%	115 50.4%

Outcome Measures

1. Primary Outcome

Title	Post LASIK Dry Eye Symptoms as Measured by Ocular Surface Disease Index (OSDI©) Score at Day 90
Description	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)).
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

Intent to Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Mean (Standard Deviation) [Scores on a Scale]	8.32 (11.125)	6.43 (8.036)

2. Secondary Outcome

Title	Patient Acceptability- Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Description	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".
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Liked using these AT (112/110)	88.4	93.6
AT helped eyes feel comfortable (112/110)	94.6	94.5
AT were soothing to eyes (111/110)	95.5	95.4
AT protected eyes from dryness (112/109)	88.4	89.9
AT protected eyes from low humidity (112/110)	78.6	82.7
Vision was normal few min.after AT use(112/110)	93.8	92.7
Few min. after use, AT gave clear vision(111/110)	94.6	94.5
AT helped eyes heal from surgery (112/110)	83.9	86.4
AT helped eyes feel same as pre-LASIK (111/110)	85.6	89.1
It's good to use AT after surgery(111/109)	97.3	96.3

3. Secondary Outcome

Title	Patient Acceptability (Sensory) - Percentage of Patients Who Rated Artificial Tears (AT) as Acceptable at Day 90
Description	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".
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Thickness of AT is just right (112/109)	79.5	87.2
AT did not interfere with vision (112/108)	64.3	82.4
AT did not cause my eyes to get crusty (112/108)	66.1	80.6
AT were easy to use (112/109)	99.1	99.1
AT were convenient to use (112/109)	96.4	91.7
AT were important to a good outcome (111/109)	82.0	80.7
AT were helpful to achieve comfort (112/109)	92.0	93.6
AT were helpful to achieve good vision (112/109)	71.4	76.1
I no longer feel I need to use AT (111/108)	43.2	38.0

4. Secondary Outcome

Title	Best Corrected Visual Acuity (BCVA) Status at Day 90
Description	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.
Time Frame	Day 90

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	113	114
Better	8	7
No Change	104	107
Worse	1	0

5. Secondary Outcome

Title	Change From Baseline of the Worse Eye in Corneal Topography as Measured by Pentacam at Day 90
Description	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.
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline	31.95 (11.941)	32.32 (15.347)
Change from Baseline at Day 90	-2.12 (6.321)	-2.24 (6.267)

6. Secondary Outcome

Title	Change From Baseline of the Worse Eye in Corneal Topography Measured by Humphrey Atlas at Day 90
Description	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.
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline	1.32 (0.855)	1.25 (0.456)
Change from Baseline at Day 90	-0.49 (0.899)	-0.26 (0.396)

7. Secondary Outcome

Title	Change From Baseline of Total Higher Order Aberration (HOA) of the Worse Eye at Day 90
Description	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.
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline	0.521 (0.1842)	0.520 (0.1845)
Change from Baseline at Day 90	-0.058 (0.1509)	-0.047 (0.1452)

8. Secondary Outcome

Title	Change From Baseline of the Worse Eye in Schirmer's Test at Day 90
Description	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.
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline	16.3 (8.40)	13.5 (6.30)
Change from Baseline at Day 90	-0.3 (8.75)	1.7 (9.59)

9. Secondary Outcome

Title	Change From Baseline of the Worse Eye in Corneal Staining With Fluorescein at Day 90
Description	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).
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

Intent to Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline	0.5 (1.13)	0.5 (1.12)
Change from Baseline at Day 90	0.0 (1.12)	0.0 (1.47)

10. Secondary Outcome

Title	Change From Baseline of the Worse Eye in Conjunctival Staining With Lissamine Green at Day 90
Description	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).
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline	1.0 (1.98)	0.8 (1.32)
Change from Baseline at Day 90	0.0 (1.65)	-0.3 (1.24)

11. Secondary Outcome

Title	Change From Baseline of the Worse Eye in Tear Break-Up Time (TBUT) at Day 90
Description	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).
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

Intent-to-Treat population defined as all patients who started the study and were randomized

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline	13.66 (6.133)	13.25 (5.250)
Change from Baseline at Day 90	-0.92 (6.013)	-0.87 (12.924)

12. Other Pre-specified Outcome

Title	Number of Patients Prescribed to Each Dosing Regimen at Day 14 and Day 60
Description	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.
Time Frame	Day 14, Day 60

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Day 14: at least every 2 hrs (113/110)	20	22
Day 14: 6-8 times a day (113/110)	30	30
Day 14: 3-5 times a day (113/110)	58	54
Day 14: 1-2 times a day (113/110)	5	4
Day 60: at least every 2 hrs (109/107)	4	3
Day 60: 6-8 times a day (109/107)	12	14
Day 60: 3-5 times a day (109/107)	62	60
Day 60: 1-2 times a day (109/107)	31	30

13. Secondary Outcome

Title	Change From Baseline in Study Product Usage at Day 90
Description	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).
Time Frame	Baseline, Day 90

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear	Carboxymethylcellulose based artificial tear
Measure Participants	114	114
Baseline (108/108)	7.9 (3.16)	7.9 (4.89)
Change from Baseline at Day 90 (108/105)	-4.9 (3.38)	-4.5 (5.97)

Adverse Events

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	Carboxymethylcellulose and Glycerin based artificial tear		Carboxymethylcellulose based artificial tear
All Cause Mortality
	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		0/114 (0%)
Other (Not Including Serious) Adverse Events
	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	88/114 (77.2%)		82/114 (71.9%)
Eye disorders
Punctate Keratitis	21/114 (18.4%)		22/114 (19.3%)
Halo Vision	10/114 (8.8%)		9/114 (7.9%)
Dry Eye	10/114 (8.8%)		8/114 (7%)
Glare	8/114 (7%)		7/114 (6.1%)
Conjucntival Haemorrhage	8/114 (7%)		6/114 (5.3%)
Foreign Body Sensation in Eyes	6/114 (5.3%)		6/114 (5.3%)
Photophobia	5/114 (4.4%)		7/114 (6.1%)
Ocular discomfort	5/114 (4.4%)		6/114 (5.3%)
Infections and infestations
Nasopharyngitis	8/114 (7%)		6/114 (5.3%)
Injury, poisoning and procedural complications
Eye Operation Complications	7/114 (6.1%)		5/114 (4.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.