Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery

• Sponsor: Eye Center of North Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT02819908
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

To compare the relative effectiveness of the Imprimis Dropless™ (TriMoxiVanc) intraocular solution with the Less Drops™ topical formulation of PredMoxiKeterolac (given for the first week post op) followed by PredKeterolac (given for weeks 2 to 4 after surgery).

The hypothesis is that the "dropless" regimen will be non-inferior to the "less drops" regimen in terms of post-operative IOP changes, post-operative healing, and visual quality.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Lens Associated Postoperative Inflammation	Drug: Imprimis Dropless; Drug: Imprimis Less Drops	Phase 4

Detailed Description

Modern cataract surgery has become a relatively short out-patient procedure with small incisions and short post-operative recovery time. Surgery can be influenced by surgical technique and experience. Prophylactic pharmaceutical regimens are designed to control post-operative pain and to reduce the potential for inflammation (i.e. macular edema, CME) and infection (i.e. endophthalmitis).

The most serious potential infection related to cataract surgery is endophthalmitis. Endophthalmitis is a result of microorganisms entering the eye, either during the surgical procedure or before surgical incisions have healed completely. The risk of infection can be reduced in several ways. Pre-operatively, reducing the bacteria on the cornea and ocular adnexa can be helpful. During surgery, appropriate technique can reduce the potential for ingress. Post-operatively, prophylactic antibiotics can eliminate organisms once they have entered the eye. Topical drops, intracameral antibiotics and subconjunctival injections are typical options in current use, usually selected on the basis of spectrum of coverage, cost, efficacy and/or expected side effects.

With regard to inflammation, one of the most common post-operative responses is cystoid macular edema (CME). Steroids and non-steroidal anti-inflammatory drugs (NSAIDs) appear effective in reducing the incidence of CME, with NSAIDs posing a lower risk for IOP spikes and showing greater efficacy some studies.

While there is documented evidence of the utility of prophylactic post-operative treatment for pain and infection, patient compliance remains a significant concern. The regimen is often complex, with multiple drops several times per day. Inability to instill the drops, forgetfulness and a lack of appreciation for the importance of compliance can all be contributing factors.

There are several new options to try to address the potential issues related to poor patient compliance. One is referred to as "dropless" cataract surgery, which involves injection of a multi-drug compound into the eye at time of cataract surgery; one such compound includes triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin (TriMoxiVanc). Another alternative is to reduce the burden of the pharmaceutical regimen using a compounded topical medication; this is termed "less drops" cataract surgery. An option in this regard is a topical formulation of prednisolone acetate, moxifloxacin hydrochloride and ketorolac tromethamine (PredMoxiKetorolac), given for one week post-operatively followed by a topical formulation of prednisolone acetate and ketorolac tromethamine (PredKeterolac) given for weeks 2 to 4 after surgery.

The purpose of this study is to evaluate the differences in performance between the dropless and less-drops pharmaceutical regimens after cataract surgery.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dropless™ vs. Less Drops™ Pharmaceutical Regimens After Cataract Surgery
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Apr 1, 2016
• Actual Study Completion Date: Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Imprimis Dropless TriMoxiVanc 0.2cc intravitreal one time	Drug: Imprimis Dropless; Tri-Moxi-Vanc transzonular intravitreal injection
Active Comparator: Imprimis Less Drops Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks.	Drug: Imprimis Less Drops; Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively

Outcome Measures

Primary Outcome Measures

1. The Change in Intraocular Pressure (IOP) From Baseline [To end of study (1 month postop)]

   Based on Goldmann tonometry

Secondary Outcome Measures

1. Change in Corneal Thickness [To end of study (1 month postop)]

   Based on corneal pachymetry

2. Slit Lamp (Cornea Exam) [To end of study (1 month postop)]

Other Outcome Measures

1. Subject Reporting no Eye Pain [To end of study (1 month postop)]

   "0"( on the eye pain/discomfort scale)

2. Change From Baseline Eye Pain/Discomfort [To end of study (1 month postop)]

   eye pain/discomfort scale

3. The Proportion of Subjects Reporting no Visual Symptoms ("0" ) [To end of study (1 month postop)]

   visual symptom scale

4. The Change From Baseline in Visual Symptoms [To end of study (1 month postop)]

   visual symptom scale

5. The Change From Baseline in Central Corneal Thickness Measurements [To end of study (1 month postop)]

   corneal pachymetry

6. The Change From Baseline in Macular Thickness Measurements [To end of study (1 month postop)]

   based on optical coherence tomography (OCT) measurement

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Ocular criteria must be met in both eyes.

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

• Gender: Males and Females.

• Age: 21 or older.

• 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 or refractive lens exchange with topical anesthesia in both eyes within 6-15 days of each other.

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

Exclusion Criteria:

• If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

• 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 refractive surgery.

• Anesthesia other than topical, oral or intravenous 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.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.

Exclusion Criteria during surgery:

If any of the following exclusion criteria are applicable to the study eye, the subject should not continue in the study.

• If full dose (0.2 cc) is not delivered into the vitreous through the zonules as evaluated by surgeon's direct visualization of the material in the posterior chamber with lack of material in the anterior chamber and an empty syringe.

• Significant vitreous loss.

• Significant anterior chamber hyphema.

• Uncontrollable intraocular pressure.

• Zonular or capsular rupture.

• Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.

• Suturing of incision required at time of surgery.

• Intraocular lens tilt or decentration

• Peri-bulbar or retro-bulbar block required during surgery.

• Other procedure, such as pupil stretch, expanders, iris hooks during surgery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Center of North Florida	Panama City	Florida	United States	32409

Sponsors and Collaborators

• Eye Center of North Florida

Investigators

• Principal Investigator: Bret L Fisher, MD, Eye Center of North Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bret L. Fisher, M.D., Principal Investigator, Eye Center of North Florida
• ClinicalTrials.gov Identifier: NCT02819908
• Other Study ID Numbers: BF-2015-011
• First Posted: Jun 30, 2016
• Last Update Posted: Mar 9, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Cataract; Capsule Opacification; Inflammation

Study Results

Participant Flow

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Period Title: Overall Study
STARTED	12	13
COMPLETED	12	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops	Total
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively	Total of all reporting groups
Overall Participants	0	0	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age () []
Sex: Female, Male () []
Female
Male
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	The Change in Intraocular Pressure (IOP) From Baseline
Description	Based on Goldmann tonometry
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection no Adverse events	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively No adverse events
Measure Participants	0	0

2. Secondary Outcome

Title	Change in Corneal Thickness
Description	Based on corneal pachymetry
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Measure Participants	0	0

3. Secondary Outcome

Title	Slit Lamp (Cornea Exam)
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Measure Participants	0	0

4. Other Pre-specified Outcome

Title	Subject Reporting no Eye Pain
Description	"0"( on the eye pain/discomfort scale)
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Measure Participants	0	0

5. Other Pre-specified Outcome

Title	Change From Baseline Eye Pain/Discomfort
Description	eye pain/discomfort scale
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection no Adverse events	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively No adverse events
Measure Participants	0	0

6. Other Pre-specified Outcome

Title	The Proportion of Subjects Reporting no Visual Symptoms ("0" )
Description	visual symptom scale
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Measure Participants	0	0

7. Other Pre-specified Outcome

Title	The Change From Baseline in Visual Symptoms
Description	visual symptom scale
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Measure Participants	0	0

8. Other Pre-specified Outcome

Title	The Change From Baseline in Central Corneal Thickness Measurements
Description	corneal pachymetry
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Measure Participants	0	0

9. Other Pre-specified Outcome

Title	The Change From Baseline in Macular Thickness Measurements
Description	based on optical coherence tomography (OCT) measurement
Time Frame	To end of study (1 month postop)

Outcome Measure Data

Analysis Population Description

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

Arm/Group Title	Imprimis Dropless	Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection	Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
Measure Participants	0	0

Adverse Events

Time Frame	Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report
Adverse Event Reporting Description	Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report
Arm/Group Title	Imprimis Dropless		Imprimis Less Drops
Arm/Group Description	TriMoxiVanc 0.2cc intravitreal one time Imprimis Dropless: Tri-Moxi-Vanc transzonular intravitreal injection no Adverse events		Pred Moxi, 1 drop tid for 1 week then, PredKeterolac bid for 2-4 weeks. Imprimis Less Drops: Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively No adverse events
All Cause Mortality
	Imprimis Dropless		Imprimis Less Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Imprimis Dropless		Imprimis Less Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Imprimis Dropless		Imprimis Less Drops
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Study data has been lost to natural disaster (Hurricane Micheal), therefore there is no study data that is available to report

More Information

Certain Agreements

All Principal Investigators ARE 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.