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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Dexamethasone
DrugDrugs to be administer during cataract surgery to experimental group
Standard of care surgery
Other interventionStandard method used for surgery and the use of post operative drops
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Preference
Patient preference for medication protocol between the two eyes as assessed by using a standard set of questions
Time frame
Day 28 of second eye surgerySecondary outcomes
1
Summed Ocular Inflamation Score
Sum of the mean anterior chamber cells and anterior flare score as measured by Slit Lamp Biomicroscopy
Time frame
Day 14 each eye2
Surgical care
Patient assessment of surgical care quality as measured by the CAHPS survey
Time frame
Day 28 of second eye surgery3
Post-operative pain
Absence of post-operative ocular pain as measured by ocular pain assessment numerical grading scale 0-10
Time frame
Day 7 each eye4
Best Corrected Visual Acuity (BCVA)
Mean change in BCVA from baseline
Time frame
2 month / 60 days Visit for second eyeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ophthalmic Consultants of Long Island
Lead sponsor
Ocular Therapeutix, Inc.
Collaborator
Source ClinicalTrials.gov