DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses

Sponsor

Prism Vision Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT04479748

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators seek to assess the effect of pre-operative and continued post-operative corticosteroid use on pain, patient preference, visual outcomes, and change in objective quantifiable biological parameters in patients undergoing bilateral cataract surgery with premium intraocular lens implantation with or without baseline ocular surface disease.

Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye). The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Dexamethasone Drug: Prednisolone Acetate 1% Oph Susp	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

DEXTENZA Compared to Topical Steroid Therapy Prior to Cataract Surgery in Patients Who Receive Premium Intraocular Lenses

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Dextenza insert Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye).	Drug: Dexamethasone Treatment of pain and inflammation following ophthalmic surgery
Other: Fellow-eye The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.	Drug: Prednisolone Acetate 1% Oph Susp Topical steroid

Arm

Intervention/Treatment

Other: Dextenza insert

Patient's first eye scheduled for surgery will receive an intracanalicular insertion of DEXTENZA (dexamethasone release profile of QID, TID, BID, QD, over 30 days; study eye).

Drug: Dexamethasone

Treatment of pain and inflammation following ophthalmic surgery

Other: Fellow-eye

The fellow-eye will receive topical prednisolone acetate 1% (tapering schedule of QID, TID, BID, QD over 30 days). The fellow-eye design in n=30 patients (60 eyes) allows for balance in patient baseline demographic and systemic characteristics.

Drug: Prednisolone Acetate 1% Oph Susp

Topical steroid

Outcome Measures

Primary Outcome Measures

Pain Scale [30 days]
Proportion of eyes with absence of pain as measured by pain scale (pain score = 0) from Baseline over each time point through Day 30. Subjects will use the Ocular Pain Assessment scale. A 0-10 point scale, where 0 is the least pain and 10 is the greatest pain, subjects will be asked to rank their level of pain.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• Age 18 or greater with plans to undergo bilateral clear cornea cataract surgery with phacoemulsification and implantation of a premium posterior chamber IOL
Schirmer's test score (anesthetized) ≥ 5 mm at Screening in either eye.
TBUT ≤ 7 seconds at Screening or Baseline in either eye.
All subjects must provide signed written consent prior to participation in any study-related procedures. Able to comply with study requirements and visit schedule.

Exclusion Criteria:

revious corneal surgery or pathology
Active or history of chronic or recurrent inflammatory eye disease in either eye
Ocular pain in either eye
Proliferative diabetic retinopathy in either eye
Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
Laser or incisional ocular surgery during the study period and 6 months prior in either eye
Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted)
Chronic daily use (defined as > 7 consecutive days at the recommended dosing frequency) of systemic narcotics for any chronic pain syndrome (eg, fibromyalgia, rheumatoid arthritis, etc.) during the study period.
Ophthalmic artificial tear drop use within 2 hours prior to any study visit. Any OTC artificial tear (preserved or unpreserved) should be continued at the same frequency and with no change in drop brand.
Use of any topical prescription ophthalmic medications (including cyclosporine [Restasis®, Cequa®] or topical lifitegrast [Xiidra®], steroids, nonsteroidal anti- inflammatory drugs [NSAIDs], anti-glaucoma medications within 7 days or during study period
Participation in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
Corticosteroids (intranasal, inhaled, topical dermatological, and perianal steroids) within 30 days prior to entry in the study are not permitted
Pregnant or breast-feeding women, women who wish to become pregnant during the length of study participation, or women of child-bearing potential.
Use of systemic NSAID greater than 375 mg per day.
Glaucoma or is on medications to treat glaucoma.
Ocular Hypertension, defined as IOP of >21 mmHg, is on medications to treat hypertension or has a history of IOP spikes in either eye including steroid-related IOP increases.
Presence of nasolacrimal duct obstruction or history of cauterization of the Punctum.
Active epiphora or clinically significant dry eye syndrome.
Know allergy or sensitivity to the investigational product or its components.
The Investigator determines that the subject should not be included for reasons not already specified (e.g, systemic or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.