A Comparison of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate Following Cataract Surgery

A Randomized, Multicenter, Masked Evaluation of 0.5% Loteprednol Etabonate Versus 1% Prednisolone Acetate for the Treatment of Inflammation Following Cataract Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01384266

Enrollment

Registered

2011-06-29

Start date

2010-05-31

Completion date

2011-11-30

Last updated

2017-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Inflammation

Keywords

Intraocular Inflammation following routine Cataract Surgery

Brief summary

Patients are routinely given steroid eye drops following cataract surgery. This study will compare 2 approved drops:Loteprednol Etabonate versus Prednisolone Acetate Eye drops used following cataract surgery. Patients will be randomly assigned to one drop or the other, and evaluated for inflammation and intraocular pressure as part of the comparison. The study Doctor will be masked as to which drop the patient receives to avoid bias.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects age 18 and older undergoing routine cataract surgery.

Exclusion criteria

1. Subjects being treated for elevated intraocular pressure, retinopathy, maculopathy, cornea or vitreous opacities that would interfere with visual acuity. 2. Subjects with diabetes, pseudoexfoliation, uveitis, corneal endothelial disease, or active Herpes Simplex Virus(HSV) or Herpes Zoster Virus(HZV) Pupil Stretch and/or Limbal Relaxing Incision(LRIs) will be allowed. 3. Subjects with previous ocular trauma or intraocular surgery 4. Subjects with sensitivities to steroids. 5. Women who are not post-menopausal or are of child bearing potential will be excluded. 6. Intraoperative complications during surgery including posterior capsule rupture and vitreous loss 7. Subjects with best visual potential in the fellow eye worse than 20/60 8. Subjects who are expected to require concurrent ocular or systemic therapy with non-steroidal anti-inflammatory drugs (NSAIDS) mast cell stabilizers, antihistamines, or decongestants within 2 days prior to or during the 21 days following surgery. (Intraoperative NSAIDS for mydriasis are permitted.) 325 mg Aspirin is permitted. 9. Subjects who are expected to require concurrent ocular or systemic corticosteroids, immunosuppressants (including Restasis) within 14 days prior to or 21 days following surgery

Design outcomes

Primary

Measure	Time frame	Description
Intraocular inflammation grading	Day 21 Post-op	Slit Lamp examination will be done at each visit to grade intraocular inflammation

Secondary

Measure	Time frame	Description
Intraocular pressure spikes	Day 21 post-op	Intraocular pressure(IOP) will be measured at each visit.

Countries

United States

Outcome results