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CompletedNCT02547623Updated Aug 21, 2018Results posted

Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

A Phase 3 interventional study of Dexamethasone and Prednisolone in Cataract, sponsored by ICON Bioscience Inc. Completed at 11 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by ICON Bioscience Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

  • A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
  • Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
Read the detailed description

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

  • A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
  • Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
02

Conditions studied

  • Cataract
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 194 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

ICON Bioscience Inc is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • undergoing cataract surgery

Exclusion criteria

Exclusion Criteria:

  • glaucoma patient, pregnancy, allergy to dexamethasone
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
194 participants (actual)

Study arms

  • Active comparator
    dexamethasone depot

    dexamethasone depot 517 mcg

    Drug: Dexamethasone

  • Active comparator
    standard of care

    prednisolone drops 1%

    Drug: Prednisolone

Interventions

  • DrugDexamethasone

    depot intracameral

    Also known as: Dexycu

  • DrugPrednisolone

    Prednisolone eye drops 1%

    Also known as: standard of care

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.

    Time frame: Baseline to postoperative day 90/ early termination

Secondary outcomes

  1. Intraocular Pressure Measurement

    Intraocular Pressure was measured by Goldmann applanation tonometry.

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

  2. Visual Acuity in Study Eye

    Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

  3. Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade

    Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

  4. Slit Lamp Biomicroscopy - Cornea Edema Grade

    Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

  5. Summary of Concomitant Medications Used in the Study Eye or Both Eyes

    Time frame: Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination

  6. Changes in the Corneal Endothelial Cell Count

    Corneal Endothelial Cell Density was measured by specular microscopy.

    Time frame: Baseline, Postoperative day 90/Early termination

  7. Optic Disc Cup-disc Ratio for the Study Eye

    Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).

    Time frame: Baseline, POD 90/Early termination

  8. Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc

    Time frame: Baseline, POD 90/Early termination

  9. Dilated Opthalmoscopy Findings - Retina (Study Eye)

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina

    Time frame: Baseline, POD 90/Early termination

  10. Dilated Opthalmoscopy Findings - Macula (Study Eye)

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.

    Time frame: Baseline, POD 90/Early termination

  11. Dilated Opthalmoscopy Findings - Choroid (Study Eye)

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid

    Time frame: Baseline, POD 90/Early termination

  12. Dilated Opthalmoscopy Findings - Vitreous (Study Eye)

    The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous

    Time frame: Baseline, POD 90/Early termination

07

Results

Posted Jun 19, 2018

Participant flow

The first patient was enrolled into the study on 06 November 2015 and the last patient completed the study on 16 August 2016.

Participant flow — Overall Study
MilestoneDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Started12655
Completed12252
Not completed43

Outcome measures

PrimaryNumber of Participants With Treatment-Emergent Adverse Events (TEAEs)

Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.

Time frame:
Baseline to postoperative day 90/ early termination
Reported as:
Count of participants · Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Ocular events: study eye — Any TEAE5313
Ocular events: study eye — Serious TEAE10
Ocular events: study eye — No TEAE7242
Ocular events: fellow eye — Any TEAE124
Ocular events: fellow eye — Serious TEAE00
Ocular events: fellow eye — No TEAE11451
Systemic events — Any TEAE106
Systemic events — Serious TEAE20
Systemic events — No TEAE11449
SecondaryIntraocular Pressure Measurement

Intraocular Pressure was measured by Goldmann applanation tonometry.

Time frame:
Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Reported as:
Mean · mmHG
Intraocular Pressure Measurement
mmHGDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline)15.1 ± 2.9414.4 ± 2.71
Post Operative Day 119.1 ± 6.5417.5 ± 6.44
Post Operative Day 815.0 ± 4.715.1 ± 3.64
Post Operative Day 3013.8 ± 3.214.1 ± 3.57
Post Operative Day 90/End of Treatment13.0 ± 2.8912.7 ± 2.93
SecondaryVisual Acuity in Study Eye

Visual Acuity assessed by the Snellen chart, was expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1

Time frame:
Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Reported as:
Mean · LogMar
Visual Acuity in Study Eye
LogMarDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline).292 ± 0.1913.355 ± .2557
Post Operative Day 1.249 ± .1398.327 ± .2129
Post Operative Day 8.073 ± .1353.073 ± .1746
Post Operative Day 30.039 ± .0952.040 ± .1350
Post Operative Day 90/End of Treatment.040 ± .1012.047 ± .1150
SecondarySlit Lamp Biomicroscopy - Conjunctival Hyperemia Grade

Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Conjunctiva hyperemia slit lamp results were summarized by treatment group and time point.

Time frame:
Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Reported as:
Count of participants · Participants
Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Baseline — 0 (Absent)12455
Baseline — 1 (Mild)10
Baseline — 2 (Moderate)10
Baseline — 3 (Severe)00
Baseline — No value00
Postoperative day 1 — 0 (Absent)10345
Postoperative day 1 — 1 (Mild)2110
Postoperative day 1 — 2 (Moderate)20
Postoperative day 1 — 3 (Severe)00
Postoperative day 1 — No value00
Postoperative day 8 — 0 (Absent)11545
Postoperative day 8 — 1 (Mild)118
Postoperative day 8 — 2 (Moderate)00
Postoperative day 8 — 3 (Severe)00
Postoperative day 8 — No value02
Postoperative day 30 — 0 (Absent)10744
Postoperative day 30 — 1 (Mild)148
Postoperative day 30 — 2 (Moderate)20
Postoperative day 30 — 3 (Severe)00
Postoperative day 30 — No value33
Postoperative day 90/End of Treatment — 0 (Absent)11950
Postoperative day 90/End of Treatment — 1 (Mild)42
Postoperative day 90/End of Treatment — 2 (Moderate)00
Postoperative day 90/End of Treatment — 3 (Severe)00
Postoperative day 90/End of Treatment — No value33
SecondarySlit Lamp Biomicroscopy - Cornea Edema Grade

Slit lamp biomicroscopy of the anterior chamber was performed using a slit beam of 1-mm height and 1-mm width with maximum luminance through the highest-powered lens using the Investigator's standard slit lamp equipment and procedure. Cornea edema slit lamp results in the study eye were summarized by treatment group and time point.

Time frame:
Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Reported as:
Count of participants · Participants
Slit Lamp Biomicroscopy - Cornea Edema Grade
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Baseline — 0 (Absent)12654
Baseline — 1 (Mild)00
Baseline — 2 (Moderate)00
Baseline — 3 (Severe)00
Baseline — No value01
Postoperative day 1 — 0 (Absent)7437
Postoperative day 1 — 1 (Mild)4315
Postoperative day 1 — 2 (Moderate)93
Postoperative day 1 — 3 (Severe)00
Postoperative day 1 — No value00
Postoperative day 8 — 0 (Absent)10948
Postoperative day 8 — 1 (Mild)166
Postoperative day 8 — 2 (Moderate)00
Postoperative day 8 — 3 (Severe)00
Postoperative day 8 — No value11
Postoperative day 30 — 0 (Absent)12152
Postoperative day 30 — 1 (Mild)00
Postoperative day 30 — 2 (Moderate)20
Postoperative day 30 — 3 (Severe)00
Postoperative day 30 — No value33
Postoperative day 90/End of Treatment — 0 (Absent)12352
Postoperative day 90/End of Treatment — 1 (Mild)00
Postoperative day 90/End of Treatment — 2 (Moderate)00
Postoperative day 90/End of Treatment — 3 (Severe)00
Postoperative day 90/End of Treatment — No value33
SecondarySummary of Concomitant Medications Used in the Study Eye or Both Eyes
Time frame:
Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination
Reported as:
Count of participants · Participants
Summary of Concomitant Medications Used in the Study Eye or Both Eyes
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Patients reporting at least one concomitant medica12455
Antiseptics and disinfectants11
Anesthetics41
Psycholeptics21
Ophthalmologicals12455
Thyroid therapy01
SecondaryChanges in the Corneal Endothelial Cell Count

Corneal Endothelial Cell Density was measured by specular microscopy.

Time frame:
Baseline, Postoperative day 90/Early termination
Reported as:
Mean · cells/mm^2
Changes in the Corneal Endothelial Cell Count
cells/mm^2Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Baseline2483.66 ± 351.8192398.33 ± 384.092
Postoperative day 90/End of treatment2141.77 ± 522.3272106.39 ± 517.938
Change from Baseline-334.60 ± 415.071-288.83 ± 376.775
SecondaryOptic Disc Cup-disc Ratio for the Study Eye

Calculated as the ratio of the diameter of the depression (cup) to that of the optical nerve head (disc).

Time frame:
Baseline, POD 90/Early termination
Reported as:
Mean · ratio
Optic Disc Cup-disc Ratio for the Study Eye
ratioDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline).31 ± .142.32 ± .135
Postoperative day 90/End of treatment.31 ± .131.33 ± .143
SecondaryDilated Opthalmoscopy Findings - Optic Disc (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's optic disc

Time frame:
Baseline, POD 90/Early termination
Reported as:
Count of participants · Participants
Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline) — Normal11552
Screening (Baseline) — Abnormal21
Screening (Baseline) — Not analyzed92
Postoperative day 90/End of treatment — Normal11950
Postoperative day 90/End of treatment — Abnormal21
Postoperative day 90/End of treatment — Not analyzed54
SecondaryDilated Opthalmoscopy Findings - Retina (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's retina

Time frame:
Baseline, POD 90/Early termination
Reported as:
Count of participants · Participants
Dilated Opthalmoscopy Findings - Retina (Study Eye)
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline) — Normal12051
Screening (Baseline) — Abnormal54
Screening (Baseline) — Not analyzed10
Postoperative day 90/End of treatment — Normal11850
Postoperative day 90/End of treatment — Abnormal51
Postoperative day 90/End of treatment — Not analyzed34
SecondaryDilated Opthalmoscopy Findings - Macula (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's macula.

Time frame:
Baseline, POD 90/Early termination
Reported as:
Count of participants · Participants
Dilated Opthalmoscopy Findings - Macula (Study Eye)
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline) — Normal10944
Screening (Baseline) — Abnormal1511
Screening (Baseline) — Not analyzed20
Postoperative day 90/End of treatment — Normal10739
Postoperative day 90/End of treatment — Abnormal1612
Postoperative day 90/End of treatment — Not analyzed34
SecondaryDilated Opthalmoscopy Findings - Choroid (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's choroid

Time frame:
Baseline, POD 90/Early termination
Reported as:
Count of participants · Participants
Dilated Opthalmoscopy Findings - Choroid (Study Eye)
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline) — Normal12454
Screening (Baseline) — Abnormal00
Screening (Baseline) — Not analyzed21
Postoperative day 90/End of treatment — Normal12250
Postoperative day 90/End of treatment — Abnormal10
Postoperative day 90/End of treatment — Not analyzed35
SecondaryDilated Opthalmoscopy Findings - Vitreous (Study Eye)

The number and percentage of patients with normal or abnormal findings from dilated opthalmoscopy examination of the study eye's vitreous

Time frame:
Baseline, POD 90/Early termination
Reported as:
Count of participants · Participants
Dilated Opthalmoscopy Findings - Vitreous (Study Eye)
ParticipantsDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Screening (Baseline) — Normal10449
Screening (Baseline) — Abnormal215
Screening (Baseline) — Not analyzed11
Postoperative day 90/End of treatment — Normal10744
Postoperative day 90/End of treatment — Abnormal167
Postoperative day 90/End of treatment — Not analyzed34

Adverse events

Collected over Adverse event data was collected from screening until postoperative day 90/end of treatment.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dexamethasone Depot0/126 (0%)3/126 (2.4%)23/126 (18.3%)
Prednisolone Drops 1% (Standard of Care)0/55 (0%)0/55 (0%)6/55 (10.9%)
Most frequent serious events
Most frequent serious events
EventDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Diabetic retinopathyEye disorders1/1260/55
Loss of consciousnessNervous system disorders1/1260/55
Abdominal herniaGastrointestinal disorders1/1260/55
Most frequent other events
Most frequent other events
EventDexamethasone DepotPrednisolone Drops 1% (Standard of Care)
Intraocular pressure increasedInvestigations14/1262/55
HeadacheNervous system disorders1/1264/55
IritisEye disorders8/1260/55

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
<=18 years000
Between 18 and 65 years341751
>=65 years9238130
Sex: Female, Male
Sex: Female, Male(Participants)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
Female673198
Male592483
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
Hispanic or Latino9110
Not Hispanic or Latino11754171
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
American Indian or Alaska Native000
Asian123
Native Hawaiian or Other Pacific Islander000
Black or African American11112
White11152163
More than one race000
Unknown or Not Reported303
Region of Enrollment
Region of Enrollment(Participants)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
United States12655181
Study Eye
Study Eye(study eye)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
OD (Right eye)672794
OS (Left eye)592887
Best Corrected Visual Acuity
Best Corrected Visual Acuity(LogMar)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
study eye number.292 ± .1913.355 ± .2557.311 ± .2141
fellow eye number.126 ± .1394.176 ± .2123.141 ± .1660
Corneal Endothelial Cell Density - Specular Microscopy
Corneal Endothelial Cell Density - Specular Microscopy(cells/mm^2)Dexamethasone DepotPrednisolone Drops 1% (Standard of Care)Total
Mean2491.91 ± 346.3652398.33 ± 384.0922463.15 ± 359.902

3 further baseline measures are reported on the registry.

08

Study locations

11 sites
  • Kislinger MD inc
    Glendora, California 91741, United States
  • Inland Eye Specialists
    Hemet, California 92545, United States
  • Harvard Eye Associated
    Laguna Hills, California 92653, United States
  • Feinerman Vision Center
    Newport Beach, California 92663, United States
  • Cincinnati Eye Institute
    Edgewood, Kentucky 41017, United States
  • Associated Eye Care
    Stillwater, Minnesota 55082, United States
  • Matossian Eye Associates
    Pennington, New Jersey 08534, United States
  • Ophthalmic Consultants of Long Island
    Garden City, New York 11530, United States
  • Cincinnati Eye Institute
    Cincinnati, Ohio 45242, United States
  • Carolina Eye Care Physicians
    Mount Pleasant, South Carolina 29464, United States
  • the eye institute of Utah
    Salt Lake City, Utah 84107, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02547623
Lead sponsor
ICON Bioscience Inc
Responsible party
Sponsor
First posted
Sep 11, 2015
Start date
Nov 6, 2015
Primary completion
Aug 16, 2016
Completion
Aug 16, 2016
Results posted
Jun 19, 2018
Last update
Aug 21, 2018

Study contacts

Eric Donnenfeld, MD
principal investigator · Ophthalmic Consultants of Long Island

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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