Bromfenac Versus Dexamethasone After Cataract Surgery

• Status: Completed
• Trial end date: 2018-12-21
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare bromfenac to dexamethasone eye drops to control inflammation after cataract surgery. Inflammation in the anterior chamber of the eye will be measured by a Laser Flare Photometer (LFP).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Treatments: BB 1101; Bromfenac; Dexamethasone; Dexamethasone acetate; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

INCLUSION CRITERIA

1. Age > 60 year old.

2. Uneventful cataract surgery. Surgical procedure, as described in the patients chart, should be free of any form of intraoperative complication that may increase postoperative inflammation.

3. Availability of relevant ocular history, including: Best Corrected Visual Acuity testing, Laser Flare Photometry, Optical Coherence Tomography, slit lamp biomicroscopy, intraocular pressure (with pneumotonometer), dilated fundus ophthalmoscopy.

4. Ability and willing to follow all instructions and attend all study visits

5. Ability to self-administer study drug (or have a caregiver available to instill all doses of study drug)

6. Ability and willing to provide informed consent for this study protocol.

7. No ocular, topical, systemic, or inhaled NSAIDs or ocular, topical, or systemic gentamicin, or cyclosporine ophthalmic emulsion within 1 week of investigational product initiation or throughout the duration of the study;

8. No topical, inhaled, or systemic corticosteroids within 15 days or depot corticosteroids within 45 days of the investigational product initiation or or throughout the duration of the study;

9. No oral tamsulosin at any time during the clinical trial;

10. Any ocular, topical, or systemic medication that could interfere with normal lacrimation, wound healing, the investigational product, or the interpretation of clinical trial results.

11. For women, the menopausal state is assumed.

EXCLUSION CRITERIA

1. Ocular exclusion criteria:

1. history of ocular inflammation or trauma;

2. history of previous intraocular surgery;

3. corneal haze, edema or any condition that can interfere with LFP measurement by means of reduced transparency of the cornea;

4. preoperative LFP value > 12 ph/ms (as per patient' chart)

5. pseudoexfoliation lentis;

6. retinal vascular diseases;

7. diabetic retinopathy;

8. any variation of the foveal profile at OCT (including macular edema and epiretinal membranes)

9. moderate to severe forms of age related macular degeneration

10. presence of any sign of intraocular inflammation (including cells or flare in the anterior chamber) in either eye (including uveitis);

11. intraoperative complications during the surgical procedure that may increase postoperative inflammation; this includes, in particular, patients with posterior capsule rupture;

12. marked intraocular inflammation at postoperative day 1, including keratic precipitates or any form of uveitis;

13. BCVA ≤ 1/10 in the non study eye

2. Systemic exclusion criteria:

1. inflammatory diseases;

2. any active or chronic/recurrent disease that was uncontrolled and was likely to affect wound healing;

3. severe blood dyscrasia or bone marrow suppression;

4. uncontrolled/unstable peptic ulcer disease

5. any uncontrolled/unstable pulmonary, cardiac, vascular, autoimmune, hepatic, renal, or central nervous system disease;

3. Known hypersensitivity to bromfenac or to any component of the investigational products, procedural medications, salicylates, or other NSAIDs.

4. Patients cannot be enrolled in another clinical study concurrently