Phase 2
N=223
Safety and Efficacy of OMS302 in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR)
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT01193127 ↗Enrolled (actual)
223
Serious AEs
0.4%
Results posted
Aug 2014
Primary outcome: Primary: Pupil Diameter (mm) During Surgery — 8.0; 8.0; 8.1; 9.0 mm — p=0.0000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- OMS302 Solution (Drug); OMS302 Mydriatic Solution (Drug); OMS302 Anti-inflammatory Solution (Drug); Balanced Salt Solution (BSS) Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Omeros Corporation
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pupil Diameter (mm) During Surgery |
8.0; 8.0; 8.1; 9.0; 8.2; 8.3 | 0.0000 sig |
| PRIMARY Ocular Pain Visual Analog Scale (VAS) Score (mm) Within 12 Hours Postoperatively |
8.6; 9.4; 4.1; 5.3; 10.9; 10.5 | 0.0421 sig |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Tearing, Two Hours Post-Surgery |
41; 34; 48; 35; 12; 13 | 0.630 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Tearing, Six Hours Post-Surgery |
34; 29; 43; 35; 12; 15 | 0.229 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Tearing, One Day Post-Surgery |
34; 29; 48; 42; 15; 19 | 0.177 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Tearing, Two Days Post-Surgery |
37; 30; 47; 41; 18; 18 | 0.480 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Tearing, Seven Days Post-Surgery |
39; 33; 46; 40; 13; 21 | 0.812 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Tearing, 14 Days Post-Surgery |
44; 45; 51; 42; 7; 10 | 0.085 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Tearing, 30 Days Post-Surgery/ Early Termination |
43; 44; 51; 49; 11; 9 | 0.081 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Photophobia Two Hours Post-Surgery |
37; 27; 36; 32; 13; 22 | 0.893 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Photophobia Six Hours Post-Surgery |
26; 29; 33; 29; 17; 16 | 0.186 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Photophobia One Day Post-Surgery |
20; 16; 36; 23; 19; 22 | 0.663 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Photophobia Two Days Post-Surgery |
26; 23; 34; 19; 18; 24 | 0.106 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Photophobia Seven Days Post-Surgery |
30; 31; 37; 37; 18; 16 | 0.100 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Photophobia 14 Days Post-Surgery |
43; 35; 42; 39; 10; 18 | 0.642 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Photophobia 30 Days Post-Surgery /Early Termination |
44; 36; 42; 40; 10; 17 | 0.695 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Eye Discharge 2 Hours Post-Surgery |
55; 50; 52; 48; 1; 6 | 0.124 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Eye Discharge Six Hours Post-Surgery |
44; 49; 41; 43; 7; 1 | 0.825 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Eye Discharge One Day Post-Surgery |
48; 45; 48; 50; 7; 9 | 0.401 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Eye Discharge Two Days Post-Surgery |
52; 48; 46; 49; 3; 7 | 0.758 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Eye Discharge Seven Days Post-Surgery |
49; 52; 52; 52; 4; 4 | 0.148 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Eye Discharge 14 Days Post-Surgery |
52; 51; 53; 49; 3; 4 | 0.646 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Eye Discharge 30 Days Post-Surgery/Early Termination |
52; 52; 53; 50; 3; 2 | 1.000 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Itching Two Hours Post-Surgery |
49; 48; 45; 47; 5; 7 | 0.789 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Itching 6 Hours Post-Surgery |
44; 43; 39; 43; 7; 9 | 0.632 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Itching One Day Post-Surgery |
45; 49; 49; 46; 10; 6 | 0.528 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Itching Two Days Post-Surgery |
45; 44; 46; 41; 11; 10 | 0.463 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Itching Seven Days Post-Surgery |
39; 47; 40; 42; 13; 9 | 0.945 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Itching 14 Days Post-Surgery |
48; 45; 44; 44; 6; 10 | 0.811 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Itching 30 Days Post-Surgery/Early Termination |
43; 46; 47; 48; 11; 8 | 0.173 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Hours Post-Surgery |
32; 26; 31; 25; 17; 24 | 0.681 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Six Hours Post-Surgery |
26; 31; 31; 34; 19; 16 | 0.226 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation One Day Post-Surgery |
36; 25; 37; 35; 13; 25 | 0.244 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Two Days Post-Surgery |
37; 39; 38; 35; 16; 11 | 0.752 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation Seven Days Post-Surgery 7 Days |
27; 32; 34; 37; 23; 17 | 0.228 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 14 Days Post-Surgery |
31; 38; 36; 42; 23; 16 | 0.018 sig |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Foreign Body Sensation 30 Days Post-Surgery/Early Termination |
41; 44; 40; 46; 12; 10 | 0.271 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Haziness Two Hours Post-Surgery |
27; 24; 28; 17; 21; 17 | 0.320 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Haziness Six Hours Post-Surgery |
24; 20; 26; 23; 21; 20 | 0.778 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Haziness One Day Post-Surgery |
34; 29; 36; 38; 15; 19 | 0.374 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Haziness Two Days Post-Surgery |
36; 31; 39; 43; 19; 17 | 0.031 sig |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Haziness Seven Days Post-Surgery |
36; 33; 34; 41; 16; 17 | 0.476 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Haziness 14 Days Post-Surgery |
39; 34; 39; 47; 10; 16 | 0.075 |
| SECONDARY Ocular Symptoms Using Numerical Rating System - Haziness 30 Days Post-Surgery/Early Termination |
38; 42; 44; 44; 14; 6 | 0.226 |
| SECONDARY Best Corrected Visual Acuity (BVCA) - Log Score, Baseline |
0.4; 0.4; 0.4; 0.4 | 0.172 |
| SECONDARY Best Corrected Visual Acuity (BVCA) - Log Score, Day 1 |
0.1; 0.2; 0.2; 0.1 | 0.701 |
| SECONDARY Best Corrected Visual Acuity (BVCA) - Log Score, Day 2 |
0.1; 0.2; 0.1; 0.1 | 0.086 |
| SECONDARY Best Corrected Visual Acuity (BVCA) - Log Score, Day 7 |
0.1; 0.1; 0.1; 0.1 | 0.626 |
| SECONDARY Best Corrected Visual Acuity (BVCA) - Log Score, Day 14 |
0.1; 0.1; 0.1; 0.1 | 0.220 |
| SECONDARY Best Corrected Visual Acuity (BVCA) - Log Score, Day 30 |
0.1; 0.1; 0.1; 0.1 | 0.675 |
| SECONDARY Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Baseline |
0.0; 0.0; 0.0; 0.0 | 0.2066 |
| SECONDARY Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, 2 Hours Post Surgery |
2.7; 2.2; 2.5; 2.5 | 0.4222 |
| SECONDARY Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 1 |
2.7; 2.3; 2.6; 2.2 | 0.0510 |
| SECONDARY Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 2 |
2.4; 2.0; 2.6; 2.2 | 0.4099 |
| SECONDARY Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 7 |
1.5; 1.4; 1.5; 1.9 | 0.0688 |
| SECONDARY Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 14 |
0.7; 0.6; 0.7; 0.8 | 0.5369 |
| SECONDARY Postoperative Ocular Inflammation in Summed Ocular Inflammation Score (SOIS) Grade, Day 30 |
0.4; 0.2; 0.3; 0.2 | 0.1374 |
| SECONDARY Subjects With Postoperative Ocular Inflammation SOIS = 0, Baseline |
56; 56; 54; 54 | 0.317 |
| SECONDARY Subjects With Postoperative Ocular Inflammation SOIS = 0, Two Hours Post-surgery |
1; 3; 1; 2 | 0.559 |
| SECONDARY Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 1 |
1; 1; 1; 0 | 0.317 |
| SECONDARY Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 2 |
1; 2; 1; 1 | 1.000 |
| SECONDARY Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 7 |
9; 11; 12; 8 | 0.824 |
| SECONDARY Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 14 |
25; 29; 28; 25 | 0.842 |
| SECONDARY Subjects With Postoperative Ocular Inflammation SOIS = 0, Day 30 |
40; 43; 42; 40 | 0.773 |
| SECONDARY Postoperative Mean Anterior Chamber Cell Count, Two Hours Post-Surgery |
11.2; 9.2; 10.9; 10.3 | 0.695 |
| SECONDARY Postoperative Mean Anterior Chamber Cell Count, Day 1 |
11.2; 9.3; 10.4; 8.4 | 0.134 |
| SECONDARY Postoperative Mean Anterior Chamber Cell Count, Day 2 |
9.1; 6.8; 10.2; 7.2 | 0.086 |
| SECONDARY Postoperative Mean Anterior Chamber Cell Count, Day 7 |
4.5; 4.2; 3.6; 6.9 | 0.206 |
| SECONDARY Postoperative Mean Anterior Chamber Cell Count, Day 14 |
1.6; 1.3; 1.6; 2.1 | 0.822 |
| SECONDARY Postoperative Mean Anterior Chamber Cell Count, Day 30 |
1.1; 0.3; 0.5; 0.5 | 0.489 |
| SECONDARY Ocular Pain VAS Score After Day 0 |
13.4; 13.0; 2.7; 7.7; 6.6; 12.6 | — |
| SECONDARY Postoperative Use of Ophthalmic Anti-inflammatory Medications |
2; 9; 8; 6; 1; 0 | 0.4575 |
| SECONDARY Use of Pain Medications at Day 1 |
0; 0; 0; 1; 1; 0 | 0.1570 |
| SECONDARY Use of Pain Medications After Day 1 |
0; 0; 0; 1; 1; 0 | 0.711 |
Summary
The purpose of this study is to determine whether the use of OMS302 (the study drug) in individuals undergoing Cataract Extraction with Lens Replacement (CELR) surgery is safe and effective at maintaining an adequately dilated pupil during surgery and reducing post-operative symptoms of discomfort (such as eye pain and irritation).
Eligibility Criteria
Inclusion Criteria
- Competent and willing to voluntarily provide informed consent
- 18 years of age or older
- In good general health needing to undergo cataract extraction with lens replacement surgery in one eye, under topical anesthesia
- Other inclusion criteria to be evaluated by the investigator
Exclusion Criteria
- No allergies to the medications and/or the active ingredients of any of the study medications
- No medications with the same activities as the of the active ingredients in OMS302 for defined time intervals prior to and after surgery
- No other significant eye injuries, eye conditions or general medical conditions likely to interfere with the evaluation of the study medication
- Other exclusion criteria to be evaluated by the investigator
Data sourced from ClinicalTrials.gov (NCT01193127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.