Page last updated: 2024-12-05

dipivefrin

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

Dipivefrin is a prodrug of epinephrine, a potent sympathomimetic amine with a wide range of pharmacological effects. It is synthesized by esterifying epinephrine with pivalic acid. Dipivefrin is poorly absorbed systemically but readily penetrates the cornea, where it is hydrolyzed to epinephrine. This local conversion of dipivefrin to epinephrine is what gives it its therapeutic effect. Dipivefrin's primary application is in ophthalmology, specifically for treating open-angle glaucoma and ocular hypertension. Its effects include reducing intraocular pressure by increasing aqueous humor outflow and decreasing aqueous humor production. Dipivefrin's importance lies in its ability to effectively manage glaucoma, a leading cause of blindness. It is studied extensively to understand its efficacy, safety, and optimal dosing regimens. Research into dipivefrin also explores its potential for treating other ophthalmic conditions and its interactions with other medications.'

dipivefrin: used in treatment of both primary & open angle glaucoma; RN given refers to (+-)-isomer [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

dipivefrin : The dipivalate ester of (+-)-epinephrine (racepinephrine). A pro-drug of epinephrine, the hydrochloride is used topically as eye drops to reduce intra-ocular pressure in the treatment of open-angle glaucoma or ocular hypertension. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID3105
CHEMBL ID1201262
CHEBI ID4646
SCHEMBL ID24713
MeSH IDM0064267

Synonyms (65)

Synonym
BRD-A47494775-003-03-0
dipivefrin [usan]
(+-)-3,4-dihydroxy-alpha-((methylamino)methyl)benzyl alcohol 3,4-dipivalate
4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylen dipivalat
dipivefrina [inn-spanish]
k 30081
dipivefrinum [inn-latin]
propanoic acid, 2,2-dimethyl-, 4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylene ester, (+-)-
NCGC00179499-01
PRESTWICK3_000632
BPBIO1_000688
BSPBIO_000624
AB00514686
C06963
52365-63-6
dipivefrin
dipivefrine
1-(3',4'-dipivaloyloxyphenyl)-2-methylamino-1-ethanol
dipivalyl epinephrine
DB00449
4-[1-hydroxy-2-(methylamino)ethyl]-o-phenylene divavalate
(+/-)-4-[1-hydroxy-2-(methylamino)ethyl]-o-phenylene divavalate
2,2-dimethylpropanoic acid 4-[1-hydroxy-2-(methylamino)ethyl]-1,2-phenylene ester
dipivefrin (usan)
D02349
dipivefrine (inn)
PRESTWICK0_000632
PRESTWICK1_000632
SPBIO_002843
PRESTWICK2_000632
4-[1-hydroxy-2-(methylamino)ethyl]benzene-1,2-diyl bis(2,2-dimethylpropanoate)
dipivefrina
CHEBI:4646 ,
(+-)-4-[1-hydroxy-2-(methylamino)ethyl]-o-phenylene divavalate
dipivefrinum
L000915
[2-(2,2-dimethylpropanoyloxy)-4-[1-hydroxy-2-(methylamino)ethyl]phenyl] 2,2-dimethylpropanoate
mfcd00673243
AKOS003662293
CHEMBL1201262
(+-)-2,2-dimethylpropansaeure-4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylenester
8q1pvl543g ,
unii-8q1pvl543g
(+-)-4-(1-hydroxy-2-methylaminoethyl)-o-phenylendipivalat
(rs)-4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylen dipivalat
dipivefrine [inn]
2-[(2,2-dimethylpropanoyl)oxy]-4-[1-hydroxy-2-(methylamino)ethyl]phenyl 2,2-dimethylpropanoate
gtpl7166
dipivefrine [mart.]
dipivefrin [mi]
propanoic acid, 2,2-dimethyl-, 4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylene ester, (+/-)-
dipivefrin [vandf]
dipivefrine [who-dd]
SCHEMBL24713
DTXSID1048544
4-[1-hydroxy-2-(methylamino)ethyl]-1,2-phenylene bis(2,2-dimethylpropanoate)
OCUJLLGVOUDECM-UHFFFAOYSA-N
2-[(2,2-dimethylpropanoyl)oxy]-5-[1-hydroxy-2-(methylamino)ethyl]phenyl 2,2-dimethylpropanoate
HY-121398
FT-0745765
Q905952
NCGC00179499-05
4-(1-hydroxy-2-(methylamino)ethyl)-1,2-phenylene bis(2,2-dimethylpropanoate)
EN300-17997011
CS-0081941

Research Excerpts

Overview

Dipivefrin is an antiglaucoma prodrug that is hydrolyzed to the active drug, epinephrine, by esterases in the cornea. It is a safe, effective, and well-tolerated alternative to Epinephrine in the treatment of elevated IOP.

ExcerptReferenceRelevance
"Dipivefrin is an antiglaucoma prodrug that is hydrolyzed to the active drug, epinephrine, by esterases in the cornea. "( Effects of echothiophate on enzymatic hydrolysis of dipivefrin.
Anderson, JA; Mindel, JS; Richman, JB, 1984
)
1.96
"Dipivefrin is a safe, effective, and well-tolerated alternative to epinephrine in the treatment of elevated IOP."( Dipivefrin: current concepts.
Becker, B; Goldberg, I; Kass, MA; Kolker, AE, 1980
)
2.43
"Dipivefrin is a prodrug of epinephrine which is hydrolyzed to epinephrine after absorption into the eye. "( Site of ocular hydrolysis of a prodrug, dipivefrin, and a comparison of its ocular metabolism with that of the parent compound, epinephrine.
Anderson, JA; Davis, WL; Wei, CP, 1980
)
1.97
"Dipivefrin hydrochloride is a lipophilic prodrug for epinephrine hydrochloride, allowing lower concentration of the drug to achieve the same intraocular pressure lowering effect and having also less harmful effects than epinephrine hydrochloride. "( Corneal vascularization and opacification during long-term use of dipivefrin.
Hakala, T; Helin, H; Krootila, K; Salminen, L, 1995
)
1.97
"Dipivefrin (Propine) is an effective ocular hypotensive agent. "( Follicular conjunctivitis on Dipivefrin therapy for glaucoma.
Coleiro, JA; Lockyer, JA; Sigurdsson, H, 1988
)
2.01

Toxicity

ExcerptReferenceRelevance
"1%) developed adverse external ocular side effects severe enough to require that the drug be discontinued."( External ocular toxicity of dipivalyl epinephrine.
Leibowitz, HM; Theodore, J, 1979
)
0.26
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32

Dosage Studied

1.05% dipivefrin every 12 hours might be an adequate dosage for maximal effect. 1% is at the top of the dose-response curve.

ExcerptRelevanceReference
"1% dipivefrin are at the top of the dose-response curve."( Therapeutic index of epinephrine and dipivefrin with nasolacrimal occlusion.
Fuqua, M; Nardin, GF; Sharir, M; Zimmerman, TJ, 1992
)
1.18
"In an attempt to increase patient compliance with a dosing regimen, prescriptions for topical solutions of glaucoma medication were refilled using the C Cap, a memory aid designed to help patients to remember to instill the medication as prescribed."( Effectiveness of the C Cap in promoting prescription refill compliance among patients with glaucoma.
Chin, A; Gill, MA; Nakahiro, RK; Okamoto, MP; Sclar, DA; Skaer, TL,
)
0.13
"05% dipivefrin every 12 hours might be an adequate dosage for maximal effect."( Nasolacrimal occlusion improves the therapeutic index of antiglaucoma medications.
Sharir, M; Zimmerman, TJ, 1994
)
0.85
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (5)

RoleDescription
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
adrenergic agonistAn agent that selectively binds to and activates adrenergic receptors.
sympathomimetic agentA drug that mimics the effects of stimulating postganglionic adrenergic sympathetic nerves. Included in this class are drugs that directly stimulate adrenergic receptors and drugs that act indirectly by provoking the release of adrenergic transmitters.
antiglaucoma drugAny drug which can be used to prevent or alleviate glaucoma, a disease in which the optic nerve is damaged, resulting in progressive, irreversible loss of vision. It is often, though not always, associated with increased pressure of the fluid in the eye.
ophthalmology drugAny compound used for the treatment of eye conditions or eye diseases.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (2)

ClassDescription
ethanolamines
pivalate esterA carboxylic ester of pivalic acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Bioassays (21)

Assay IDTitleYearJournalArticle
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (149)

TimeframeStudies, This Drug (%)All Drugs %
pre-199069 (46.31)18.7374
1990's57 (38.26)18.2507
2000's15 (10.07)29.6817
2010's5 (3.36)24.3611
2020's3 (2.01)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 43.85

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index43.85 (24.57)
Research Supply Index5.30 (2.92)
Research Growth Index4.39 (4.65)
Search Engine Demand Index67.04 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (43.85)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials39 (24.38%)5.53%
Reviews8 (5.00%)6.00%
Case Studies27 (16.88%)4.05%
Observational0 (0.00%)0.25%
Other86 (53.75%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (14)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification [NCT01069172]Phase 330 participants (Actual)Interventional2010-02-28Completed
Visual Function, Non-dependence on Glasses and Global Economic Cost in Patients Undergoing Lens Surgery With ReSTOR® Multifocal Aspheric Iol Implants [NCT01088282]120 participants (Anticipated)Interventional2010-03-31Not yet recruiting
A Prospective, Randomized Comparison of Fellow Eyes Undergoing Wavefront-guided PRK Versus Wavefront-optimized PRK Using the Alcon Allegretto Eye-Q 400 Excimer Laser [NCT02091934]71 participants (Actual)Interventional2009-04-01Completed
Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Between Lenticule Extraction and Small-Incision Lenticule Extraction [NCT02540785]41 participants (Actual)Interventional2014-04-30Completed
Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL [NCT02817191]80 participants (Anticipated)Interventional2016-06-30Recruiting
A Randomised Trial of Torsional Ultrasound Versus Longitudinal Ultrasound During Phacoemulsification of Age-related Cataracts: Comparison of Intra-operative Performance and Impact on Post-operative Endothelium Integrity [NCT01010490]Phase 4360 participants (Actual)Interventional2007-05-31Completed
Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Among Lenticule Extraction, Laser in Situ Keratomileusis and Femtosecond Laser-assisted Laser in Situ Keratomileusis [NCT02551796]75 participants (Actual)Interventional2015-09-30Completed
Monovision Correction Versus Multifocal Lens Insertion Following Emulsification Cataract Surgery [NCT01998698]60 participants (Actual)Interventional2013-03-31Completed
Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study [NCT04859556]52 participants (Actual)Interventional2018-05-01Completed
Influence of Blue Light Filtering Intra Ocular Lenses on Daytime Levels of Melatonin in Patients With Non-Exudative Age-Related Macular Degeneration [NCT00444249]136 participants (Anticipated)Interventional2007-03-31Terminated(stopped due to Because only a few patients follow the inclusion and exclusion criteria.)
Infant Aphakia Treatment Study (IATS) [NCT00212134]114 participants (Actual)Interventional2004-12-31Completed
Study of the Efficacy of Brinzolamide 1% Plus Brimonidine 0.2% Versus Brimonidine 0.2% in the Prevention of Intraocular Pressure Rise After Nd-YAG Laser Capsulotomy [NCT03192826]Phase 479 participants (Actual)Interventional2016-06-20Completed
A Comparison of the Effects of Alcon DAILIES TOTAL1 and a Control High Oxygen Permeable Silicone Hydrogel Daily Disposable Contact Lens, the ACUVUE TruEye, on the Biology of the Ocular Surface and Lid Margin. [NCT02347631]118 participants (Actual)Interventional2016-04-30Completed
Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens [NCT00754338]76 participants (Actual)Interventional2008-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00212134 (8) [back to overview]Adherence to Occlusion Therapy
NCT00212134 (8) [back to overview]Parenting Stress
NCT00212134 (8) [back to overview]Parenting Stress
NCT00212134 (8) [back to overview]Percent of Patients With 1 or More Adverse Events
NCT00212134 (8) [back to overview]Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery
NCT00212134 (8) [back to overview]Visual Acuity
NCT00212134 (8) [back to overview]Visual Acuity - Subjective Assessment at Age 10 Years.
NCT00212134 (8) [back to overview]Visual Acuity - Subjective Assessment at Age 4.5 Years.
NCT00754338 (6) [back to overview]Comfort
NCT00754338 (6) [back to overview]Corneal Staining
NCT00754338 (6) [back to overview]Dryness
NCT00754338 (6) [back to overview]Lens Deposits
NCT00754338 (6) [back to overview]Lens Wettability
NCT00754338 (6) [back to overview]Subjective Vision
NCT01069172 (2) [back to overview]Cumulative Dissipated Energy (CDE)
NCT01069172 (2) [back to overview]Deviation From Intended Capsulotomy Diameter
NCT02347631 (2) [back to overview]Desquamation Rate of Wearing Acuvue TruEye, Then Alcon DAILIES Contact Lenses
NCT02347631 (2) [back to overview]Desquamation Rate of Wearing Alcon DAILIES, Then AcuVue TruEye Contact Lenses
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy
NCT03192826 (4) [back to overview]Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy

Adherence to Occlusion Therapy

Parental report of the number of hours children wore an patch to occlude the fellow eye. (NCT00212134)
Timeframe: Phase 1 - 12 months follow-up

InterventionHours patched per day (Mean)
Aphakic Contact Lens3.92
Aphakic Intraocular Lens3.63

[back to top]

Parenting Stress

The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252 (NCT00212134)
Timeframe: Phase 1 - Age 12 Months

Interventionunits on a scale (Mean)
Aphakic Contact Lens202.6
Aphakic Intraocular Lens208.3

[back to top]

Parenting Stress

The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252. (NCT00212134)
Timeframe: Phase 1 - 3 months post surgery

Interventionunits on a scale (Mean)
Aphakic Contact Lens197.4
Aphakic Intraocular Lens231.1

[back to top]

Percent of Patients With 1 or More Adverse Events

(NCT00212134)
Timeframe: Study enrollment to age 5 years

Interventionpercentage of patients (Number)
Aphakic Contact Lens56
Aphakic Intraocular Lens81

[back to top]

Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery

Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery (NCT00212134)
Timeframe: Cataract surgery immediately after enrollment

Interventionpercentage of patients (Number)
Aphakic Contact Lens11
Aphakic Intraocular Lens28

[back to top]

Visual Acuity

Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units. (NCT00212134)
Timeframe: Phase 1 - Age 12 months

InterventionlogMAR units (Median)
Aphakic Contact Lens0.80
Aphakic Intraocular Lens0.97

[back to top]

Visual Acuity - Subjective Assessment at Age 10 Years.

Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 10.5 years of age allowing the use of the electronic early treatment diabetic retinopathy study (E-ETDRS) testing protocol. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). (NCT00212134)
Timeframe: Phase 3 - Age 10.5 Years

InterventionlogMAR units (Median)
Aphakic Contact Lens0.86
Aphakic Intraocular Lens0.89

[back to top]

Visual Acuity - Subjective Assessment at Age 4.5 Years.

Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel. (NCT00212134)
Timeframe: Phase 2 - Age 4.5 Years

InterventionlogMAR units (Median)
Aphakic Contact Lens0.90
Aphakic Intraocular Lens0.90

[back to top]

Comfort

Subjective comfort ratings on analog scale (0= very poor comfort; 100= excellent comfort), self report by subject based on single criterion 'comfort'. (NCT00754338)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Ph1: RepleniSH(No-rub) & Supraclens86
Ph1: RepleniSH(Rub)86
Ph2: RepleniSH(No-rub) & Supraclens87
Ph2: ReNu Multiplus(Rub)86

[back to top]

Corneal Staining

"Grading based on Type (0=None; 100=patch)and extent of staining (0=None; 100= Entire corneal region). Final value is Type multiplied by Extent.~Corneal staining is a test that uses an orange dye (fluorescein) and a blue light to detect damage to the cornea (front surface of eye) from minor abrasions.~A strip of blotting paper containing the dye was touched to the eyelid margin. Upon blinking, the dye spreads and coats the front surface of the eye along with the tear film covering the surface of the cornea. The investigator then rated the size, location and shape of the staining." (NCT00754338)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Ph1: RepleniSH(No-rub) & Supraclens47
Ph1: RepleniSH(Rub)55
Ph2: RepleniSH(No-rub) & Supraclens52
Ph2: ReNu Multiplus(Rub)322

[back to top]

Dryness

Subjective dryness ratings on analog scale (0= very dry; 100= not dry at all), self report by subject based on single criterion 'dryness'. (NCT00754338)
Timeframe: 4 weeks

InterventionUnits on a Scale (Mean)
Ph1: RepleniSH(No-rub) & Supraclens85
Ph1: RepleniSH(Rub)86
Ph2: RepleniSH(No-rub) & Supraclens85
Ph2: ReNu Multiplus(Rub)85

[back to top]

Lens Deposits

Subjective grading of contact lens surface deposits by investigator (0=no deposits; 4=severe deposits). (NCT00754338)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Ph1: RepleniSH(No-rub) & Supraclens0.51
Ph1: RepleniSH(Rub)0.54
Ph2: RepleniSH(No-rub) & Supraclens0.62
Ph2: ReNu Multiplus(Rub)0.93

[back to top]

Lens Wettability

Subjective grading of contact lens surface wettability by investigator (0=excellent; 4=severely reduced). (NCT00754338)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Ph1: RepleniSH(No-rub) & Supraclens0.71
Ph1: RepleniSH(Rub)0.72
Ph2: RepleniSH(No-rub) & Supraclens0.92
Ph2: ReNu Multiplus(Rub)1.21

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Subjective Vision

Subjective vision ratings on analog scale (0= poor vision; 100= excellent vision), self report by subject based on single criterion 'vision'. (NCT00754338)
Timeframe: 4 weeks

InterventionUnits on a scale (Mean)
Ph1: RepleniSH(No-rub) & Supraclens89
Ph1: RepleniSH(Rub)89
Ph2: RepleniSH(No-rub) & Supraclens90
Ph2: ReNu Multiplus(Rub)90

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Cumulative Dissipated Energy (CDE)

"CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:~CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)~0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification." (NCT01069172)
Timeframe: Day of Surgery

InterventionCDE (Mean)
FS Laser Surgery11.58
CCC Surgery18.54

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Deviation From Intended Capsulotomy Diameter

Capsulotomy diameter measured during surgery for both the experimental and control groups. (NCT01069172)
Timeframe: Day of Surgery

Interventionμm (Mean)
FS Laser Surgery26.8
CCC Surgery339.1

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Desquamation Rate of Wearing Acuvue TruEye, Then Alcon DAILIES Contact Lenses

"Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Acuvue TRUEYE contacts lenses.~Initial 1 mo. washout period (baseline 1).~Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 1.~Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contact lenses.~Second 1 mo. washout period (baseline 2).~Participant wears the Alcon DAILIES contacts for 2 months after baseline 2." (NCT02347631)
Timeframe: Baseline + 3 months

Interventioncells/min. (Mean)
ACUVUE TRUEYE Contact Lenses53.48
Alcon DAILIES Contact Lenses54.19

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Desquamation Rate of Wearing Alcon DAILIES, Then AcuVue TruEye Contact Lenses

"Group 1: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing Alcon DAILIES contacts lenses.~Initial 1 mo. washout period (baseline 1).~Participant wears the Alcon DAILIES contacts for 2 months after baseline 1.~Group 2: Rate of desquamation of corneal epithelial cells (cells/min) will be assessed for participants wearing AcuVue TRUEYE contact lenses.~Second 1 mo. washout period (baseline 2).~Participant wears the Acuvue TRUEYE contacts for 2 months after baseline 2." (NCT02347631)
Timeframe: Baseline + 3 months

Interventioncells/min (Mean)
Alcon DAILIES TOTAL1 Contact Lenses53.86
ACUVUE TRUEYE Contact Lenses54.05

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Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 1 hour

,,
InterventionmmHg (Mean)
Baseline1 hour
Artificial Tears15.219.5
Brimonidine 0.2%15.714.7
Brinzolamide/Brimonidine FC15.613.7

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Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 1 week

,,
InterventionmmHg (Mean)
Baseline1 week
Artificial Tears15.215.6
Brimonidine 0.2%15.715.3
Brinzolamide/Brimonidine FC15.615.5

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Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 24 hours

,,
InterventionmmHg (Mean)
Baseline24 hours
Artificial Tears15.215.8
Brimonidine 0.2%15.715.5
Brinzolamide/Brimonidine FC15.614.6

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Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy

Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP (NCT03192826)
Timeframe: 3 hours

,,
InterventionmmHg (Mean)
Baseline3 hours
Artificial Tears15.219.5
Brimonidine 0.2%15.714.7
Brinzolamide/Brimonidine FC15.612.7

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