Study of T-PRED(TM) Compared to Pred Forte(R) II

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00854061
• Collaborator: (none)
• Enrollment: 172
• Location: 1
• Arms: 2
• Duration (Months): 5.9
• Patients Per Site Per Month: 28.9

Study Details

Study Description

Brief Summary

Study of T-PRED(TM) Compared to Pred Forte(R)

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: T-Pred; Drug: Pred Forte	Phase 3

Detailed Description

This study was a multi-center, randomized, double-masked, bioequivalence study. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point.

The investigator determined which eye was clinically suited for the first operative procedure; treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.

Study Design

• Study Type: Interventional
• Actual Enrollment: 172 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T-Pred Tobramycin prednisolone acetate combination	Drug: T-Pred; sterile ophthalmic solution
Active Comparator: Pred Forte Prednisolone acetate	Drug: Pred Forte; sterile ophthalmic solution

Outcome Measures

Primary Outcome Measures

1. Means Aqueous Humor Prednisolone Acetate Concentration [35 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older

Exclusion Criteria:

• No active or adverse disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ISTA Pharmaceuticals, Inc.	Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Tim McNamara, PharmD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00854061
• Other Study ID Numbers: CL-PKT-0415083-P
• First Posted: Mar 2, 2009
• Last Update Posted: Oct 20, 2020
• Last Verified: Oct 1, 2020

• Additional relevant MeSH terms: Cataract; Prednisone; Prednisolone acetate; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone hemisuccinate; Prednisolone phosphate

Study Results

Participant Flow

Arm/Group Title	All Study Participants
Arm/Group Description	Participants received both treatment groups, one in each eye. A total of 172 participants undergoing bilateral cataract surgery were assigned investigational product to each eye according to a computer-generated randomization list for each of 2 study variables: treatment with T-PRED or Pred Forte in the first eye undergoing cataract extraction and the aqueous humor sampling time point. The investigator determined which eye was clinically suited for the first operative procedure (surgery); treatment of this eye was randomized to either T-PRED or Pred Forte. The second eye received the other study treatment (RP if the first eye received T-PRED; T-PRED if the first eye received Pred Forte) at the time of the second cataract extraction.
Period Title: Overall Study
STARTED	172
Completed 1st Surgery (T-PRED in One Eye and Pred Forte in the Other Eye)	162
Completed 2nd Surgery (T-PRED and Pred Forte in Opposite Eyes Compared to 1st Surgery)	149
COMPLETED	149
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Overall
Arm/Group Description	Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.
Overall Participants	172
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.1 (9.6)
Sex: Female, Male (Count of Participants)
Female	112 65.1%
Male	60 34.9%

Outcome Measures

1. Primary Outcome

Title	Means Aqueous Humor Prednisolone Acetate Concentration
Time Frame	35 days

Outcome Measure Data

Analysis Population Description

Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.

Arm/Group Title	T-Pred	Pred Forte
Arm/Group Description	Tobramycin prednisolone acetate combination T-Pred: sterile ophthalmic solution	Prednisolone acetate Pred Forte: sterile ophthalmic solution
Measure Participants	162	162
Measure eyes	81	81
Mean (Standard Deviation) [ng/mL]	100.02 (9.61)	131.65 (9.61)

Adverse Events

Time Frame	35 days
Adverse Event Reporting Description	The safety population was comprised of participants who received study treatment and had at least one post-baseline safety assessment. Participants received both treatment groups, one in each eye. The treatment assigned to an eye (right or left) was randomly assigned.g
Arm/Group Title	T-Pred		Pred-Forte
Arm/Group Description
All Cause Mortality
	T-Pred		Pred-Forte
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	T-Pred		Pred-Forte
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/162 (0.6%)		1/162 (0.6%)
Eye disorders
IOL dislocation	1/162 (0.6%)		0/162 (0%)
Vitritis	0/162 (0%)		1/162 (0.6%)
Other (Not Including Serious) Adverse Events
	T-Pred		Pred-Forte
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/162 (0%)		0/162 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.