Trial Outcomes & Findings for Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells (NCT NCT00478036)

Results Overview

IOP, measured by Goldmann applanation tonometry

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

31 participants

Primary outcome timeframe

8 weeks

Results posted on

2016-10-07

Participant Flow

Prospective study participants will be identified by a routine clinic visit at Rocky Mountain Lions Eye Institute, University of Colorado, and need to undergo selective laser trabeculoplasty treatment for their glaucoma. A study investigator will make the initial patient contact for recruitment.

The patients enrolled in this study will follow standard of care practice in regards to selective laser trabeculoplasty with the exception that the patients will be randomized 1:1:1 (Acular LS: Pred Forte: Refresh Tears) to the inflammation treatment given after the procedure.

Participant milestones

Participant milestones
Measure	Acular LS Acular LS - 1 drop in treated eye, 4 times a day, for 4 days Acular LS: Details covered in arm description	Pred Forte Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days Pred Forte: Details covered in arm description	Refresh Tears Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days Refresh Tears: Placebo
Overall Study STARTED	10	7	14
Overall Study COMPLETED	10	7	14
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Group n=14 Participants Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days	Acular Group n=10 Participants Used acular LS	Predforte Group n=7 Participants Used predforte eye drops	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Age, Continuous	68 years n=5 Participants	69.5 years n=7 Participants	73 years n=5 Participants	69 years n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Reported for subjects for whom all IOP values were available for all of the visits.

IOP, measured by Goldmann applanation tonometry

Outcome measures

Outcome measures
Measure	Acular LS n=9 Participants Acular LS - 1 drop in treated eye, 4 times a day, for 4 days Acular LS: Details covered in arm description	Pred Forte n=7 Participants Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days Pred Forte: Details covered in arm description	Refresh Tears n=11 Participants Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days Refresh Tears: Placebo
Interocular Pressure Baseline	16.1 mmHg Standard Deviation 3.1	17.0 mmHg Standard Deviation 3.3	17.8 mmHg Standard Deviation 4.5
Interocular Pressure Day 1	11.6 mmHg Standard Deviation 2.2	12.4 mmHg Standard Deviation 2.5	13.4 mmHg Standard Deviation 3.3
Interocular Pressure Week 1	15.2 mmHg Standard Deviation 3.3	15.7 mmHg Standard Deviation 2.8	15.6 mmHg Standard Deviation 3.7
Interocular Pressure Week 4	14.3 mmHg Standard Deviation 2.6	14.0 mmHg Standard Deviation 2.4	14.6 mmHg Standard Deviation 3.5
Interocular Pressure week 8	14.0 mmHg Standard Deviation 2.3	15.0 mmHg Standard Deviation 1.6	15.8 mmHg Standard Deviation 3.1

Adverse Events

Acular LS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pred Forte

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Refresh Tears

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Malik Kahook, MD

University of Colorado, Dept. of Ophthalmology

Phone: 720-848-2501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place