Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and… (NCT05857267) | Clinical Trial Compass
CompletedPhase 4
Dorzolamide+Timolol Multidose Preservative-free vs Dorzolamida+Timolol BAK Preserved Efficacy and Safety
Argentina84 participantsStarted 2023-03-07
Plain-language summary
The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Older than 18 years old
* Patients with POAG and OH
* PIO \< 20 mmHg
* Under treatment with Dorzolamide + Timolol BAK preserved at least 6 month after
* OSDI \> 13 \& one of these ocular signs (BUT \<6sec or Schirmer test \< 5 mm/5min or corneal staining positive)
* Corneal thickness between 520-580 um.
Exclusion Criteria:
* Patient with severe respiratory diseases (asthma, COPD and other bronchospactic diseases).
* Patient with cardiovascular diseases (Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock).
* Severe renal impairment (CrCl \<30 mL/min)
* Progressive diseases of the retina other than glaucoma
* Inflammation and/or infecctions active
* Ocular surface syndrome other than Ocular Surface disease
* Eyelid disorder
* Systemic adminsitration of Betablockers or carbonic anhydrase inhibitors
* Patient that requires another antigluacomatous eye drop other than fixed combination of Dorzolamide/Timolol
* Patients who use regularly lubricant eye drops
* Patient who use regularly contact lenses
* Patient with autoinmune diseases
* Patients who underwent kerato-refractive laser procedures, cornea or corneal surface surgery, including, but not limited to, LASIK and PRK, within 6 months prior to the baseline visit.
* Patients who have undergone a laser procedure or intraocular surgery or extraocular in either eye within 6 months prior to the baseline visit.
* Patients with severe central visual field loss in either eye based onclinical judgme…
What they're measuring
1
Ocular Surface Disease Symptoms
Timeframe: Change from baseline in OSDI score at 24 weeks