A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
ConditionPatient Preference
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22-100
SponsorOphthalmic Consultants of Long Island
About this trial
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
Eligibility criteria
Qualifiers
A male or female subject in good general health (as determined by the Investigator), > 22 years of age at the time of the screening visit
A subject must be willing and able to sign informed consent
A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide.
A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits
Disqualifiers
A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye
A subject with a puncta >0.9 mm prior to dilation in their scheduled surgical eye
A subject experiencing significant ocular pain or discomfort in either eye at the screening visit or on the day the plug is to be inserted
Trial design
Treatments tested in this trial
- Dexamethasone
- Standard of care surgery
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ophthalmic Consultants of Long Island
Lead sponsor
Ocular Therapeutix, Inc.
Collaborator
Source ClinicalTrials.gov