An interventional study of Nepafenac 0.3% and Saline Solution in Cystoid Macular Edema, sponsored by Intuor Technologies, Inc.. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-14.
Sponsored by Intuor Technologies, Inc. · Not applicable, Interventional, and Treatment
Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's enrollment of 662 is above the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Intuor Technologies, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
nepafenac 0.3% ophthalmic solution dosed once daily
Drug: Nepafenac 0.3%
sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
Drug: Saline Solution
Post-operative Clinical Findings of Cystoid Macular Edema
post-operative macular volume (mm)
Time frame: 6 weeks
| Milestone | Nepafenac 0.3% | Saline Solution |
|---|---|---|
| Started | 331 | 331 |
| Completed | 331 | 331 |
| Not completed | 0 | 0 |
post-operative macular volume (mm)
| mm | Nepafenac 0.3% | Saline Solution |
|---|---|---|
| Post-operative Clinical Findings of Cystoid Macular Edema | 8.85 ± 0.13 | 8.95 ± 0.18 |
Collected over 3 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nepafenac 0.3% | — | 0/331 (0%) | 1/331 (0.3%) |
| Saline Solution | — | 0/331 (0%) | 0/331 (0%) |
| Event | Nepafenac 0.3% | Saline Solution |
|---|---|---|
| drop intoleranceEye disorders | 1/331 | 0/331 |
Six hundred and sixty two (662) patients, one thousand eyes (1000), completed the study. 1:1 ratio of control: treatment. Subjects were chosen from patients who had visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
| Age, Continuous(years) | Nepafenac 0.3% | Saline Solution | Total |
|---|---|---|---|
| Mean | 68.8 (31 to 94) | 67.9 (39 to 96) | 68.3 (31 to 96) |
| Sex: Female, Male(Participants) | Nepafenac 0.3% | Saline Solution | Total |
|---|---|---|---|
| Female | 182 | 182 | 364 |
| Male | 149 | 149 | 298 |
| Macular volume(mm) | Nepafenac 0.3% | Saline Solution | Total |
|---|---|---|---|
| Mean | 8.7 ± 0.15 | 8.75 ± 0.15 | 8.72 ± 0.15 |
No study locations are listed for this record.
Plan to share: No
The record gives a start of Oct 2013, a primary completion of Jan 2017 and a completion of Jan 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2018, 1 year 11 months after primary completion.
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This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nepafenac
Intuor Technologies, Inc.