Clinical Outcomes and Evaluation of Lotemax 0.5% in Treatment of Ocular Inflammation Associated With Cataract Surgery

• Sponsor: Toyos Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT01344226
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Duration (Months): 29
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

Investigate the intraocular pressure(pressure inside the eye) of patients who are treated with Lotemax after undergoing cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Pseudophakia; Inflammation	Drug: loteprednol 0.5% ophthalmic solution

Detailed Description

This is a single-center study to evaluate the clinical outcomes of Lotemax 0.5% for the treatment of Ocular inflammation associated with cataract surgery. Subjects will be screened from one to 21 days prior to initiation of dosing with the test article. Subjects who sign the informed consent document and meet all inclusion/exclusion criteria will be eligible to participate in this study. Subjects will instill one drop of Lotemax into the study (operative) eye QID for a maximum of 22 days. Dosing with test article will begin the day of surgery and for 21 days after surgery. Subjects will be seen for evaluation on Days 1, 7±1, and 21 ± 2 following surgery. Subjects will be seen for a follow-up visit on Day 42 ± 3 following surgery, about 21 days after their last dose of test article.

In addition to the test article regimen, subjects will receive Vigamox TID 3 days prior to surgery. Patients will receive one drop of Timoptic XE 0.5%, Zymaxid on the day of surgery. Postoperatively, patients will receive Vigamox TID for ten days and Bromday QD for 3 weeks.

Study Design

• Study Type: Observational
• Actual Enrollment: 49 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Clinical Outcomes and Evaluation of Lotemax (Loteprednol Ophthalmic Solution ) 0.5% QID for Treatment of Ocular Inflammation Associated With Cataract Surgery
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Outcome Measures

Primary Outcome Measures

1. Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation. [baseline to 6 weeks]

   Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.

Secondary Outcome Measures

1. ETDRS Letters Read Over Early Postoperative Period [change in ETDRS letters read baseline to 6 weeks]

   Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.

2. Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification [baseline to 6 weeks]

   Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.

3. Flare Scores in Early Postoperative Period [baseline to 6 weeks]

   Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or Female 18 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular) with posterior chamber intraocular lens implantation.

2. Agree not to have any other ocular surgery in the study or fellow eye for duration of study.

3. Have a BCVA of 20/200 or better in either eye.

4. Willing/able to return for all required study visits.

5. Willing/able to follow instructions from the study investigator and their staff.

6. Able to self-administer test article (or have a caregiver available to instill all doses of test article).

7. If woman capable of becoming pregnant, agree to have urine pregnancy test(must be negative) at agree to use a medically acceptable form of birth control during study and for at least one week prior to and after completion of the study.

8. Have read, understood, and signed the informed consent document approved by Sterling Institutional Review Board.

9. Have IOP ≥ 5mmHg and ≤ 22mmHg, (in study eye) with or without anti-glaucoma therapy at the pre-operative screening visit (if > 22mmHg, adjust following pachymetry).

Exclusion Criteria:

1. Have known hypersensitivity to Lotemax or to any component of the test article (including "procedural" medications such as anesthetic and/or fluorescein drops, dilating drops, etc.).

2. Have a known hypersensitivity to non-steroidal or steroidal anti-inflammatory drugs (NSAIDs).

3. Have intraocular inflammation (i.e. cells or flare in the anterior chamber as measured on slit lamp exam) in the study eye at the screening visit.

4. Have a known blood dyscrasia or bone marrow suppression, a diagnosis of uncontrolled/unstable peptic ulcer disease, inflammatory bowel disease, or ulcerative colitis, or any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease.

5. Have used ocular, topical, or systemic steroids within 14 days or depot steroid 30 days prior to initiation of dosing with the test article or throughout the duration of the study. Note: use of an opioid during surgery (e.g., fentanyl) is allowed.

6. Have uncontrolled glaucoma or IOP >/= 27mmHg.

7. Have active corneal pathology noted in the study eye at the screening visit. Active corneal pathology is defined as corneal pathology that is non-stable, or greater than mild, or will compromise assessment of the safety or efficacy of treatment.

8. Are pregnant or nursing.

9. Have participated in any other study of an investigational drug or device within 30 days prior to randomization.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Discover Vision Centers	Independence	Missouri	United States	64055

Sponsors and Collaborators

• Toyos Clinic

Investigators

• Principal Investigator: Melissa Toyos, MD, Discover Vision Centers

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click on "Current Studies"

Publications

None provided.

• Responsible Party: Melissa Toyos, Principal Investigator, Toyos Clinic
• ClinicalTrials.gov Identifier: NCT01344226
• Other Study ID Numbers: MMC-2011A
• First Posted: Apr 29, 2011
• Last Update Posted: Oct 22, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Melissa Toyos, Principal Investigator, Toyos Clinic: steroid responder
• Additional relevant MeSH terms: Cataract; Inflammation; Pseudophakia; Loteprednol Etabonate; Ophthalmic Solutions

Study Results

Participant Flow

Recruitment Details	Patients in one location of one surgeon's clinic about to undergo cataract surgery were recruited from July 2011 to May 2013.
Pre-assignment Detail	patients had to be off of steroids for 14 days with no depot steroid injection for 30 days

Arm/Group Title	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Arm/Group Description	Subjects instilled one drop of topical loteprednol 0.5% suspension qid into the operative eye four times daily for a maximum of 22 days. Dosing began on the day of surgery and continued for 21 days postoperatively.
Period Title: Overall Study
STARTED	49
COMPLETED	41
NOT COMPLETED	8

Baseline Characteristics

Arm/Group Title	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Arm/Group Description	patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Overall Participants	49
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 28.6%
>=65 years	35 71.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.93 (9.61)
Sex: Female, Male (Count of Participants)
Female	30 61.2%
Male	19 38.8%
Region of Enrollment (participants) [Number]
United States	49 100%

Outcome Measures

1. Primary Outcome

Title	Investigate Clinical Outcomes for Intraocular Pressure After Treatment With Lotemax (Loteprednol Ophthalmic Solution) 0.5% QID in Subjects Who Have Undergone Cataract Extraction With Posterior Chamber Intraocular Implantation.
Description	Evaluate intraocular pressure change in mm Hg from baseline in the first 6 weeks following cataract surgery in individuals treated with Lotemax (loteprednol ophthalmic solution) 0.5% QID after cataract extraction with posterior chamber intraocular implantation.
Time Frame	baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Arm/Group Description	patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Measure Participants	49
Mean (Standard Error) [mm Hg]	-1.8 (1.06)

2. Secondary Outcome

Title	ETDRS Letters Read Over Early Postoperative Period
Description	Final visual acuity at pod 42 as measured by ETDRS letters read was compared with baseline was measured for this outcome measure.
Time Frame	change in ETDRS letters read baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Arm/Group Description	patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Measure Participants	41
Mean (Standard Error) [change in ETDRS letters read]	8.05 (2.14)

3. Secondary Outcome

Title	Cell Scores in the Early Outcome Period as Measured at 6 Weeks Post Phacoemulsification
Description	Cell scores at the final visit (pod 42) will be compared with baseline cells and will be measured using 1mmx1mm slit lamp beam. White cells present in the anterior chamber in a 1mm x 1mm slit lamp beam measured 3 times with the average number of cells being recorded. The grading scale was 0 (no cells/high power field), 1 (1-5 cells/high power field), 2 (6-15 cells/high power field), 3 (16-25 cells/high power field) and 4 (>25 cells/high power field). Minimal values represent less inflammation or better inflammatory control and could represent a better outcome.
Time Frame	baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Arm/Group Description	patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Measure Participants	41
Mean (Standard Error) [units on a scale]	0.25 (1.11)

4. Secondary Outcome

Title	Flare Scores in Early Postoperative Period
Description	Flare scores will be measured using a 1mmx1mm slit lamp beam. Flare was assessed by looking at a 1mmx1mm slit lamp beam into the anterior chamber. Three measurements were taken and the average flare score was reported. The final outcome measure was the final flare score at 42 days compared to baseline. The grading scale was 0-4 with 0 repesenting no flare, 1mild flare, 2 moderate flare, 3 moderate severe and 4 severe flare. Minmal values represent less inflammation and could represent better inflammatory control.
Time Frame	baseline to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Arm/Group Description	patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
Measure Participants	41
Mean (Standard Error) [units on a scale]	0.08 (0.78)

Adverse Events

Time Frame	6 weeks after phacoemulsification was performed
Arm/Group Title	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
Arm/Group Description	patients received loteprednol 0.5% suspension for 21 days following surgery in addition to pre and postoperative standard of care
All Cause Mortality
	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	Patients Receiving Loteprednol 0.5% Qid Post Phacoemulsificati
	Affected / at Risk (%)	# Events
Total	3/49 (6.1%)
Eye disorders
increasing ocular cell	3/49 (6.1%)	3

Limitations/Caveats

Single surgeon, single site study with no randomization or masking. Fewer patients analyzed than anticipated due to competitive recruiting with similar studies.4 screen failures and 8 early terminations.

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.