The Utility of IVCM to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With DED

• Sponsor: Tufts Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02120079
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Duration (Months): 47.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This research study is looking to see if in vivo confocal microscopy (IVCM) imaging can be used to confirm clinical findings (which are noted by the doctor during an eye exam) and measure the immune response to the inflammation in the subject's cornea (the front part of the eyeball).

Additionally, this study is trying to determine the effectiveness of two eye-drops, Lotemax and artificial tears, in treating the inflammation associated with DED by measuring changes in immune cells with IVCM imaging. The subject will be treated with either Lotemax (loteprednol) or artificial tears (a lubricating eye drop with no medication). Lotemax is an FDA-approved steroid eye-drop that is often used to treat inflammation associated with DED. Artificial tears are approved by the FDA for treatment of dryness associated with DED.

Thus, this study is designed to determine the effects of the administration of a topical steroid, Lotemax, over a treatment period of 6 weeks, using novel methods of detecting efficacy. In order to achieve the aforementioned goal, subjects will be prospectively randomized to one of two treatment arms - Lotemax or artificial tear. Both groups will follow the same study schedule.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: Lotemax; Drug: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears); Diagnostic Test: In Vivo Confocal Microscopy (IVCM)	Phase 4

Detailed Description

IVCM is a non-invasive imaging technique that images the cornea at a cellular level with 800x magnification, using a scanning laser. The laser is used to map the cornea, and will not damage or harm the subject's eye. Studies have shown that IVCM can be used to study cells and nerves within the cornea, providing a better understanding of how the cornea reacts to irritants. IVCM has recently been used by the investigator to assess the extent of eye inflammation in cases of dry eye patients.

Current steroid therapy in dry eye disease (DED) is comprised of a 2 week duration of pulse therapy, administered twice daily (to avoid adverse effects associated with long-term steroid use). This time frame is often too short to meaningfully resolve the inflammation associated with DED. DED often occurs when there is a decrease in the eye's tear production or if there is an increase in the evaporation of the tear film (a thin layer of tears that keep the eye moist). Eye irritation and inflammation (swelling) is often associated with DED because the surface of the eye is unable to maintain a normal level of moisture.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Utility of in Vivo Confocal Microscopy (IVCM) to Assess Cellular Response and Efficacy of Long-term Topical Steroid Treatment in Patients With Dry Eye Disease (DED)
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: Jan 28, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lotemax Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension supplied by Bausch & Lomb, Inc. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.	Drug: Lotemax; Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.; Other Names: Lotemax (loteprednol etabonate) 0.5% ; Diagnostic Test: In Vivo Confocal Microscopy (IVCM); In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Active Comparator: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears) Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.	Drug: Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears); Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.; Other Names: Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) ; Diagnostic Test: In Vivo Confocal Microscopy (IVCM); In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.

Outcome Measures

Primary Outcome Measures

1. IVCM for Density of Corneal Immune Dendritiform Cells [2 Weeks]

   Density (in cells/mm2) of Corneal Immune Dendritiform Cells

2. IVCM for Density of Corneal Immune Dendritiform Cells [6 Weeks]

   Density (in cells/mm2) of corneal immune dendritiform cells

3. IVCM for Corneal Immune Dendritiform Cell (DC) Morphology [2 Weeks]

   Morphology (in cells/mm2) of Corneal Immune Dendritiform Cells

4. IVCM for Corneal Immune Dendritiform Cell (DC) Morphology [6 Weeks]

   Morphology (in cells.mm2) of Corneal Immune Dendritiform Cells

Secondary Outcome Measures

1. Ocular Signs: Corneal Epitheliopathy [2 Weeks]

   Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome

2. Ocular Signs: Corneal Epitheliopathy [6 Weeks]

   Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome

3. Ocular Signs: Conjunctival Epitheliopathy [2 Weeks]

   Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome

4. Ocular Signs: Conjunctival Epitheliopathy [6 Weeks]

   Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome

5. Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire [2 Weeks]

   Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome

6. Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire [6 Weeks]

   Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome

7. Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry [2 Weeks]

   Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg

8. Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry [6 Weeks]

   Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg

9. Ocular Signs: Tear Break Up Time (TBUT) [2 Weeks]

   Tear Break Up Time (TBUT) will be recorded in seconds

10. Ocular Signs: Tear Break Up Time (TBUT) [6 Weeks]

    Tear Break Up Time (TBUT) will be recorded in seconds

11. Ocular Signs: Schirmer's Test With Anesthesia [2 Weeks]

    The Schirmer's Test (performed using Anesthesia) will be measured in mm.

12. Ocular Signs: Schirmer's Test With Anesthesia [6 Weeks]

    The Schirmer's Test (performed using Anesthesia) will be measured in mm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 89 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18-89 years.

• Willing and able to provide written informed consent.

• Willing and able to comply with study assessments for the full duration of the study.

• In good stable overall health.

• Corneal dendritiform cell count by confocal microscopy of >=75/mm2 (13 immune cells per image)

• Diagnosis of dry eye disease based on the followings:

• Symptoms of dry eye disease such as foreign body sensation, burning, stinging, light sensitivity for at least 6 months.

• Two or more of the following objective signs:

• Schirmer test with anesthesia <10 mm at 5 minutes [mean Schirmer between eyes.

• Tear break-up time (TBUT) of <10 seconds.

• Corneal fluorescein staining of 4 (NEI grading scheme, 0-15) in at least one eye

• Lissamine green staining of the nasal and temporal conjunctiva (NEI grading scheme, 0-18) in at least one eye

Exclusion Criteria:

• Central corneal subbasal dendritic cell count by in vivo confocal microscopy of <75/mm2 in both eyes

• Active ocular allergies

• Active allergies to steroids, aminoglycosides, or benzalkonium chloride (BAK)

• History of contact lens wear within 3 months before enrollment.

• Intraocular surgery or ocular laser surgery within 3 months before enrollment.

• History of ocular infection within 3 months before enrollment.

• History of topical (for ophthalmic use) or systemic steroid treatment (Loteprednol (other than Lotemax suspension used in our study), Difluprednate, Fluorometholone, Prednisolone, Dexamethasone, Triamcinolone, Rimexolone, Medrysone) within 1 month before enrollment. In case of topical ophthalmic steroid use, a wash-out period of 1 month is required.

• History of increased intraocular pressure after using topical steroids (steroid responsive)

• Change in systemic immunosuppression medication in the past 3 months.

• History of any change in the frequency of topical cyclosporine or oral tetracycline compounds (tetracycline, doxycycline, and minocycline) within 1 month before enrollment.

• Any condition (including language barrier) that precludes subject's ability to comply with study requirements including completion of study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tufts Medical Center	Boston	Massachusetts	United States	02111

Sponsors and Collaborators

• Tufts Medical Center

Investigators

• Principal Investigator: Pedram Hamrah, MD, Tufts Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 13, 2017

More Information

Publications

None provided.

• Responsible Party: Tufts Medical Center
• ClinicalTrials.gov Identifier: NCT02120079
• Other Study ID Numbers: 13-150H; NCT02106377
• First Posted: Apr 22, 2014
• Last Update Posted: Mar 23, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Tufts Medical Center: Dry Eye
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Loteprednol Etabonate; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Period Title: Baseline
STARTED	17	20
COMPLETED	17	20
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	17	20
COMPLETED	17	20
NOT COMPLETED	0	0
Period Title: Baseline
STARTED	17	20
COMPLETED	17	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)	Total
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Total of all reporting groups
Overall Participants	17	20	37
Overall Eyes	28	34	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.29 (12.62)	55.35 (15.78)	56.24 (14.25)
Sex: Female, Male (Count of Participants)
Female	12 70.6%	17 85%	29 78.4%
Male	5 29.4%	3 15%	8 21.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Corneal immune dendritiform cell (DC) density at Baseline (cells/mm2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/mm2]	26.83 (14.98)	34.59 (29.15)	30.97 (23.76)
Corneal immune dendritiform cell (DC) morphology at Baseline (cells/mm2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cells/mm2]	90.79 (16.67)	92.29 (23.82)	91.59 (20.64)
Corneal fluorescein staining at Baseline (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	3.39 (2.50)	4.06 (3.27)	3.76 (2.94)
OSDI at Baseline (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	56.93 (29.36)	38.46 (20.34)	47.18 (26.35)
Lissamine Green at Baseline (Score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Score]	3.57 (2.71)	5.74 (4.26)	4.76 (3.78)
IOP at Baseline (mmHG) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mmHG]	14.50 (3.18)	14.97 (2.46)	14.76 (2.79)
TBUT at Baseline (Seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Seconds]	3.99 (2.18)	4.17 (3.30)	4.09 (2.82)
Schirmer's at Baseline (mm in 10 min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm in 10 min]	10.44 (8.94)	10.57 (9.35)	10.51 (9.09)

Outcome Measures

1. Primary Outcome

Title	IVCM for Density of Corneal Immune Dendritiform Cells
Description	Density (in cells/mm2) of Corneal Immune Dendritiform Cells
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure eyes	28	34
Mean (Standard Deviation) [cells/mm2]	9.47 (5.13)	28.60 (26.09)

2. Primary Outcome

Title	IVCM for Density of Corneal Immune Dendritiform Cells
Description	Density (in cells/mm2) of corneal immune dendritiform cells
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure eyes	24	34
Mean (Standard Deviation) [cells/mm2]	9.80 (5.10)	34.03 (31.92)

3. Primary Outcome

Title	IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
Description	Morphology (in cells/mm2) of Corneal Immune Dendritiform Cells
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	28	34
Mean (Standard Deviation) [cells/mm2]	109.50 (40.56)	97.95 (30.92)

4. Primary Outcome

Title	IVCM for Corneal Immune Dendritiform Cell (DC) Morphology
Description	Morphology (in cells.mm2) of Corneal Immune Dendritiform Cells
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	24	34
Mean (Standard Deviation) [Cells/mm2]	102.31 (26.25)	89.34 (24.73)

5. Secondary Outcome

Title	Ocular Signs: Corneal Epitheliopathy
Description	Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	28	34
Mean (Standard Deviation) [Score]	1.86 (2.12)	3.18 (2.55)

6. Secondary Outcome

Title	Ocular Signs: Corneal Epitheliopathy
Description	Corneal Fluorescein Staining Using the National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-15 Higher score means worse outcome
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension supplied by Bausch & Lomb, Inc. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Lotemax: Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	26	34
Mean (Standard Deviation) [Score]	2.00 (1.98)	3.59 (2.75)

7. Secondary Outcome

Title	Ocular Signs: Conjunctival Epitheliopathy
Description	Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	28	32
Mean (Standard Deviation) [Score]	3.79 (3.47)	4.50 (4.13)

8. Secondary Outcome

Title	Ocular Signs: Conjunctival Epitheliopathy
Description	Conjunctival Lissamine Green Staining Using National Eye Institute (NEI) Grading Scheme Minimum score-0 Maximum score-18 Higher score means worse outcome
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	26	34
Mean (Standard Deviation) [Score]	2.46 (1.86)	3.44 (3.55)

9. Secondary Outcome

Title	Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
Description	Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	19
Mean (Standard Deviation) [Score]	47.25 (27.36)	33.16 (23.55)

10. Secondary Outcome

Title	Ocular Symptoms: Ocular Surface Disease Index (OSDI) Questionnaire
Description	Total Score of the Ocular Surface Disease Index (OSDI) Questionnaire Minimum score- 0 Maximum score-100 Higher score means worse outcome
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	16	20
Mean (Standard Deviation) [Score]	46.63 (29.15)	36.04 (23.30)

11. Secondary Outcome

Title	Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
Description	Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	27	32
Mean (Standard Deviation) [mmHg]	15.52 (2.87)	14.50 (3.32)

12. Secondary Outcome

Title	Ocular Signs: Intraocular Pressure (IOP) by Measure of Applanation Tonometry
Description	Intraocular Pressure (IOP) will be measured via Applanation and the result will have these units: mmHg
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	26	34
Mean (Standard Deviation) [mmHg]	16.88 (2.30)	13.76 (3.32)

13. Secondary Outcome

Title	Ocular Signs: Tear Break Up Time (TBUT)
Description	Tear Break Up Time (TBUT) will be recorded in seconds
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	28	32
Mean (Standard Deviation) [Seconds]	5.20 (3.48)	3.93 (1.91)

14. Secondary Outcome

Title	Ocular Signs: Tear Break Up Time (TBUT)
Description	Tear Break Up Time (TBUT) will be recorded in seconds
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	26	34
Mean (Standard Deviation) [Seconds]	4.83 (3.68)	3.44 (2.04)

15. Secondary Outcome

Title	Ocular Signs: Schirmer's Test With Anesthesia
Description	The Schirmer's Test (performed using Anesthesia) will be measured in mm.
Time Frame	2 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	28	32
Mean (Standard Deviation) [mm]	7.98 (4.98)	6.88 (5.92)

16. Secondary Outcome

Title	Ocular Signs: Schirmer's Test With Anesthesia
Description	The Schirmer's Test (performed using Anesthesia) will be measured in mm.
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lotemax	Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax 0.5% is FDA approved for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. Lotemax 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): IVCM is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.	Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
Measure Participants	17	20
Measure Eyes	25	34
Mean (Standard Deviation) [mm]	8.16 (4.78)	8.18 (6.06)

Adverse Events

Time Frame	6 Weeks
Arm/Group Title	Lotemax		Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
Arm/Group Description	Lotemax (loteprednol etabonate) 0.5% is a prescription-only, preserved ophthalmic suspension. Lotemax (loteprednol etabonate) 0.5% has been approved by the FDA for treatment of ocular inflammation with a maximum dosing frequency of 24 drops per eye per day. It is a C-20 ester-based corticosteroid, with a potent anti-inflammatory efficacy, but decreased impact on intraocular pressure (IOP) compared to other corticosteroids, which may increase IOP. The medication will be applied topically to both eyes for 6 weeks with the following regimen: four times daily for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Lotemax: Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of		Soothe Tired Eyes Lubricant Eye Drop (Bausch & Lomb Inc.) is a preserved artificial tear which is used to relieve the dryness of the eye and to prevent further irritation. Its active ingredient is glycerin 1%. The artificial tear will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears): Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks. In Vivo Confocal Microscopy (IVCM): In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
All Cause Mortality
	Lotemax		Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/20 (0%)
Serious Adverse Events
	Lotemax		Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Lotemax		Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.