Dropless vs. Standard Drops Contralateral Eye Study

• Sponsor: Carolina Eyecare Physicians, LLC (Other)
• Overall Status: Completed
• CT.gov ID: NCT02515045
• Collaborator: Science in Vision (Other)
• Enrollment: 59
• Locations: 4
• Arms: 3
• Duration (Months): 14
• Patients Per Site: 14.8
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

To compare the use of an injectable compound containing an antibiotic and an anti-inflammatory at time of cataract surgery to standard of care that is the use 3 different topical medications to prevent inflammation and infection after routine cataract surgery.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: TriMoxiVanc; Drug: Moxifloxacin HCl 0.5%; Drug: Ilevro; Drug: Prednisolone acetate 1%	Phase 4

Detailed Description

Key factors for a successful cataract surgery include, among others, preoperative measurements for accurate intraocular lens (IOL) calculation, surgical technique and surgeon's experience but also the use of prophylactic topical antibiotics and anti-inflammatories (steroidal and non-steroidal, NSAID) to decrease the risk of postoperative infection (i.e. endophthalmitis) and intraocular inflammation (i.e. macular edema, CME).

Even though, the large body of literature that supports the significance of prophylactic eye drops prior to surgery, patient compliance is a common problem. Different factors have been associated with patient's lack of compliance. It could be due to patient's inability to self administer the drops, lack of understanding of the importance of using the prophylactic treatment as well as understanding the instructions of how to administer the drops and its storage, or just forgetfulness or the fact that they don't like to put the drops multiple times a day for 2-4 weeks, therefore they just avoid doing it.

There is a new option called "Dropless cataract surgery". This modality of treatment involves the injection of an eye compatible compound at time of cataract surgery.

The purpose of is to assess the efficacy the compound injected during routine cataract surgery and intraocular (IOL) implantation with and without a topical NSAID compared to standard prophylactic treatment that includes the topical use of Moxifloxacin, Ilevro, and Prednisolone acetate 1%.

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Comparison of Dropless Prophylaxis After Routine Phacoemulsification to Standard Drops Regimen
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: TriMoxiVanc The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.	Drug: TriMoxiVanc; triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.; Other Names: Dropless
Active Comparator: TriMoxiVanc + Ilevro Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD.	Drug: TriMoxiVanc; triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.; Other Names: Dropless ; Drug: Ilevro; NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.; Other Names: Nepafenac 0.3%
Active Comparator: Control Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.	Drug: Moxifloxacin HCl 0.5%; Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.; Other Names: Vigamox, Moxeza ; Drug: Ilevro; NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.; Other Names: Nepafenac 0.3% ; Drug: Prednisolone acetate 1%; Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.; Other Names: Pred Forte, Econopred Plus, Omnipred

Outcome Measures

Primary Outcome Measures

1. Change From Baseline (Preoperative Exam) in Macular Thickness [Month 1.]

   Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.

Secondary Outcome Measures

1. Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness) [Month 1]

   Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter. An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery.

2. Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP) [Month 1.]

   Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject is undergoing bilateral cataract extraction or refractive lens exchange with intraocular lens implantation.

• Willing and able to provide written informed consent for participation in the study.

• Willing and able to comply with scheduled visits and other study procedures.

• Willing and able to administer eye drops and record the times the drops were instilled.

• Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-15 days between surgeries.

• Potential postoperative best-corrected visual acuity of 20/30 or better

Exclusion Criteria:

• Severe preoperative ocular pathology: amblyopia, rubella cataract, proliferative diabetic retinopathy, shallow anterior chamber, macular edema, aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, macular degeneration (with anticipated best postoperative visual acuity less than 20/30), advanced glaucomatous damage, etc.

• Presence of epiretinal membrane.

• Uncontrolled diabetes.

• Use of any systemic or topical drug known to interfere with visual performance.

• Contact lens use during the active treatment portion of the trial.

• Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.

• History of chronic intraocular inflammation.

• History of retinal detachment.

• Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.

• Previous radial keratotomy.

• Any additional ocular surgical procedures at time of cataract extraction (i.e. iStent) except corneal incisions for the correction of astigmatism.

• Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).

• Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.

• Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.

• Intraocular conventional surgery within the past three months or intraocular laser surgery within one month.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Minnesota Eye Consultants, P.A.	Bloomington	Minnesota	United States	55431
2	Associated Eye Care	Stillwater	Minnesota	United States	55082
3	Ophthalmic Consultants of Long Island	Garden City	New York	United States	11530
4	Carolina Eyecare Physicians, LLC	Mount Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

• Carolina Eyecare Physicians, LLC
• Science in Vision

Investigators

• Principal Investigator: Kerry D Solomon, MD, Carolina Eyecare Physicians, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carolina Eyecare Physicians, LLC
• ClinicalTrials.gov Identifier: NCT02515045
• Other Study ID Numbers: CEP 14-002
• First Posted: Aug 4, 2015
• Last Update Posted: Feb 23, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Carolina Eyecare Physicians, LLC: Cataract; Surgery; Prophylaxis
• Additional relevant MeSH terms: Cataract; Moxifloxacin; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Nepafenac; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Recruitment Details	Study recruitment started on December 2014 and ended in March 2016. Potential subjects were identified from the patients presenting at the clinics for eye evaluation.
Pre-assignment Detail	No significant events in the study occurred after participant enrollment, but prior to randomization.

Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description	The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.	Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.	Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Period Title: Overall Study
STARTED	29	30	59
COMPLETED	29	26	55
NOT COMPLETED	0	4	4

Baseline Characteristics

Arm/Group Title	TriMoxiVanc One Eye + Control Fellow Eye	TriMoxiVanc + Ilevro One Eye + Control Fellow Eye	Total
Arm/Group Description	Subject's eyes were randomized to either TriMoxiVan or Control group. TriMoxiVanc group: Triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml used as an injection delivered into the vitreous cavity using a transzonular approach at the end of the uneventful phacoemulsification procedure after IOL implantation before removal of the OVD. Control group: Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued. Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.	Subject's eyes were randomized to either TriMoxiVan + Ilevro or Control group. TriMoxiVan + Ilevro group: Nepafenac ophthalmic suspension 0.3% started 3 days prior to surgery QD and continued QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco (triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml ) injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. Control group: Moxifloxacin HCl 0.5%: 1 drop, QID for 3 days prior to surgery and continued for 2 weeks after surgery and then discontinued. Ilevro (Nepafenac ophthalmic suspension 0.3%): 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.	Total of all reporting groups
Overall Participants	29	30	59
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	67.9 (7.5)	69.3 (6.8)	68.5 (7.1)
Sex: Female, Male (Count of Participants)
Female	21 72.4%	18 60%	39 66.1%
Male	8 27.6%	12 40%	20 33.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	29 100%	30 100%	59 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	29 100%	30 100%	59 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Preoperative Exam) in Macular Thickness
Description	Macula is the area in the retina that is responsible for the best central vision. Changes in its thickness may occur after cataract surgery due to the normal inflammatory process that occurs postoperatively but it returns to preoperative values unless there is an underlying disease.
Time Frame	Month 1.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description	The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.	Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.	Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Measure Participants	29	26	55
Mean (Standard Deviation) [Microns]	12.34 (13.05)	10.96 (11.55)	9.84 (15.84)

2. Secondary Outcome

Title	Change From Baseline (Preoperative Exam) in Pachymetry (Corneal Thickness)
Description	Cornea is the clear part of the front of the eye. Normal corneal thickness is in average 0.540 mm. The corneal thickness is measured with a handheld device called pachymeter. An increase in corneal thickness may indicate corneal edema (swelling of the cornea) that could be seen after ocular surgery.
Time Frame	Month 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description	The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.	Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.	Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Measure Participants	29	26	55
Mean (Standard Deviation) [Microns]	14.44 (13.95)	5.94 (14.07)	4.47 (15.63)

3. Secondary Outcome

Title	Change From Baseline (Preoperative Exam) in Intraocular Pressure (IOP)
Description	Intraocular pressure refers to the pressure inside the eye. It is measured in mmHg using a device called a tonometer. The mean IOP is 15.5 mmHg. Raised IOP after cataract surgery is common and in most cases it is transient and benign.
Time Frame	Month 1.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	TriMoxiVanc	TriMoxiVanc + Ilevro	Control
Arm/Group Description	The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.	Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.	Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
Measure Participants	29	26	55
Mean (Standard Deviation) [mmHg]	-0.5 (2.8)	-1.03 (3.3)	-1.1 (3.0)

Adverse Events

Time Frame	In average, adverse event data was collected for 6 weeks from the time the Informed consent was signed until patient exited the study.
Adverse Event Reporting Description	Adverse events were classified as related to study treatment or not related. All reported adverse events were considered not related to study treatment.
Arm/Group Title	TriMoxiVanc		TriMoxiVanc + Ilevro		Control
Arm/Group Description	The formulation containing triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin used as an injection at the end of the uneventful phacoemulsification procedure. The compounded Tri-Moxy-Vanco will be delivered into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.		Nepafenac ophthalmic suspension 0.3% will be started 3 days prior to surgery QD and continue QD for 4 weeks after surgery. The compounded Tri-Moxy-Vanco will be injected into the vitreous cavity using a transzonular approach after IOL implantation before removal of the OVD. TriMoxiVanc: triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.		Moxifloxacin HCl 0.1%, 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Nepafenac ophthalmic suspension 0.3% : 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1% will be started after surgery QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued. Moxifloxacin HCl 0.5%: Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue. Ilevro: NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery. Prednisolone acetate 1%: Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
All Cause Mortality
	TriMoxiVanc		TriMoxiVanc + Ilevro		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	TriMoxiVanc		TriMoxiVanc + Ilevro		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/29 (0%)		0/26 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	TriMoxiVanc		TriMoxiVanc + Ilevro		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/29 (10.3%)		1/26 (3.8%)		5/55 (9.1%)
Eye disorders
Dry eyes	1/29 (3.4%)		0/26 (0%)		1/55 (1.8%)
Rebound inflammation	0/29 (0%)		1/26 (3.8%)		2/55 (3.6%)
Allergic conjuctivitis	0/29 (0%)		0/26 (0%)		1/55 (1.8%)
Posterior vitreous detachments	1/29 (3.4%)		0/26 (0%)		1/55 (1.8%)
Retinal detachment	1/29 (3.4%)		0/26 (0%)		0/55 (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.