Phase 4
Completed N=62
COSOPT-S® Treatment Versus Acetazolamide Before Trabeculectomy
Source: ClinicalTrials.gov NCT01228149 ↗Enrolled (actual)
62
Serious AEs
11.9%
Results posted
Apr 2017
Primary outcomePrimary: Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP — 8.30; 8.12 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The most common cause of post-trabeculectomy filtration failure is postoperative scarring. Long-term preoperative treatment with local antiglaucoma agents containing preservatives has an increased risk of post-operative scarring of the filtration bleb. Therefore many surgeons prepare their patients for planned trabeculectomy by discontinuing local antiglaucoma drugs, controlling IOP with oral acetazolamide, and treating the eye with local steroids.
Preservative-free COSOPT-S® eye drops b.i.d now provide a possibility to reduce IOP preoperatively with the aim of avoiding postoperative excessive scarring and the known adverse effects of oral acetazolamide while achieving comparable IOP reduction and long-term outcomes.
This study will investigate comparability (non-inferiority) of medical benefits of two different IOP lowering pharmaceutical interventions prior to trabeculectomy comparing COSOPT-S® bid to oral acetazolamide plus dexamethasone.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure (IOP) (ΔIOP) Three Months After Trabeculectomy in Comparison to the Mean Preoperative IOP |
8.30; 8.12 | — |
| SECONDARY Number of Needling |
0; 2 | — |
| SECONDARY Number of Necessary 5-Fluorouracil (5FU) Injections |
5.14; 5.26 | — |
| SECONDARY Ocular Hypotension Rate |
5; 3 | — |
| SECONDARY Change in IOP Between Visit 1 and 2 |
8.19; 1.88 | — |
| SECONDARY Filtration Bleb Classification |
4; 2; 14; 17; 5; 5 | — |
| SECONDARY Change in Quality of Life |
80.71; 79.48 | — |
| SECONDARY Change in Conjunctival Redness |
1; 0; 13; 12; 13; 15 | — |
| SECONDARY Number of Suture Lyses |
11; 10; 10; 12; 7; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged 18 years or older
- Caucasian
- A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes
- Planned trabeculectomy
- Previous treatment with antiglaucoma agents containing preservatives for at least one month
- Best corrected visual acuity of 20/800 or better in the study eye
Exclusion Criteria
- Secondary glaucoma except pseudoexfoliation glaucoma and pigmentary glaucoma
- Current ocular infection, i.e. conjunctivitis or keratitis
- Any abnormality preventing reliable applanation tonometry
- Intraocular surgery or laser treatment within the past three months
- History of surgery involving the conjunctiva
- History of cataract surgery with sclerocorneal approach
- Subject is allergic to sulfonamides
- Reactive airway disease, including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
- Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock
- Severe renal dysfunction (CrCl < 30 ml/min) or hyperchloraemic acidosis
- Depressed blood levels of sodium and / or potassium
- Marked kidney and liver disease or dysfunction, gout, suprarenal gland failure, hypercalciuria or nephrocalcinosis
- History of hypersensitivity to the investigational medicinal products or to any drug
Data sourced from ClinicalTrials.gov (NCT01228149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.